855 Lims Jobs - Page 3

As a SAP PP & QM Technical Architect at Birlasoft, you will be a key player in leveraging your expertise to deliver successful SAP implementations. With a focus on Logistics tracks such as OTC, PTP, or SCM, you will utilize your deep knowledge of PP and QM module functionalities to drive efficiency and productivity within the organization. With a minimum of 10 years of experience, including 3 to 5 end-to-end ECC and S/4HANA implementations, you will be responsible for ensuring seamless integrations with other modules such as MM, CS, FICO, PP, and PM. Your role will also involve acting as a functional expert, promptly identifying and resolving application issues to provide timely solutions. In addition to your technical skills, you will bring hands-on experience in ServiceNow and expertise in handling support, development, and rollout projects. Your proficiency in writing documents like Functional specifications, Business process documents, and Functional documents will be crucial in documenting project requirements and solutions. Furthermore, your familiarity with integration systems like LIMS, BizTalk, and knowledge of PLM systems with ECS DB will be advantageous. Experience with label printing software such as BarTender, TLAshford/BPCS, and SAP MII will also be beneficial in executing successful initiatives. Overall, as a SAP PP & QM Technical Architect, you will play a pivotal role in providing consulting services on new and existing initiatives, contributing to the growth and success of the organization.,

we are hiring for pan india location updated resume please share to Balaji.V254c1a@cognizant.com Job Description: TULIP Senior Developer Role Summary As a TULIP Senior Developer at Cognizant, you will lead the design, development, and deployment of advanced Tulip applications. You will work closely with business stakeholders, architects, and cross-functional teams to deliver scalable, compliant, and innovative manufacturing solutions. Key Responsibilities - Design and develop custom Tulip applications using low-code/no-code tools. - Implement complex workflows, logic, and integrations with enterprise systems. - Integrate Tulip with LIMS, ERP, QMS, SCADA, and IoT devices. - Develop APIs and connectors for seamless data exchange. - Mentor junior developers and provide technical guidance. - Review code, ensure best practices, and maintain high-quality standards. - Support CSV activities and ensure applications meet GxP and 21 CFR Part 11 requirements. - Monitor application performance and implement improvements. - Troubleshoot and resolve technical issues efficiently. Required Skills - Strong hands-on experience with Tulip platform. - Proficiency in JavaScript, SQL, and RESTful APIs. - Experience with low-code/no-code development, IoT, and cloud platforms. - Deep understanding of Life Science processes and GxP compliance. - Excellent problem-solving, communication, and leadership skills. Preferred Qualifications - Bachelors or Master’s degree in Computer Science, Engineering, or related field. - Certifications in Tulip, or related technologies. - Experience in life sciences or regulated manufacturing environments.

Mandatory Skills: Integrating systems - LIMS, eBMR, SAP, UAM systems Integrate data Flow diagrams Total Exp : 5+ years Job Description: Must have experience integrating LIMS, eBMR, SAP, UAM systems Expertise in application integration and will be responsible for Integration of Veeva application with other applications like Have strong technical and business knowledge and ensures seamless interaction between different applications. Integrate data from internal and external interfaces and create flow diagrams for end to end data mapping with a focus on traceability.

We are seeking an experienced ELN (Benchling, iLab, Biovia & Lab Informatics) Product Owner with strong domain expertise in electronic lab notebook (ELN) platforms, especially Benchling and Biovia. This role will serve as the functional lead responsible for defining the product vision and working closely with scientific and technical teams within Pharma or Life Sciences organizations to drive ELN development, integration, and adoption. Key Responsibilities Define and manage product vision, roadmap, and backlog for ELN solutions Gather and prioritize business and scientific requirements from R&D and lab users Collaborate with cross-functional technical teams to lead ELN development and customization Ensure seamless integration of ELN systems with LIMS, CDS, SDMS, and other lab informatics platforms Align ELN solutions with regulatory frameworks (e.g., GxP, ALCOA+) and industry standards Drive stakeholder engagement and support user onboarding through training and documentation Act as liaison between business and development teams to ensure product alignment and value delivery Primary Skills Product ownership and lifecycle management for ELN platforms Hands-on expertise with Benchling and Biovia Requirement gathering and backlog management Familiarity with lab informatics systems: LIMS, CDS, SDMS Knowledge of Pharma/Life Sciences domain practices and workflows Understanding of regulatory compliance standards: GxP, ALCOA+ Strong stakeholder engagement and cross-team collaboration Secondary Skills Business analysis experience in life sciences or pharmaceutical R&D Experience with user training and documentation processes Agile product development methodologies Excellent communication and presentation skills Preferred Qualifications Bachelors or Masters degree in Life Sciences, Pharmaceutical Sciences, or a related field 4+ years of experience in product ownership, business analysis, or platform integration roles Prior experience managing ELN initiatives for Pharma or Life Sciences organizations Proven track record of successfully delivering lab informatics solutions.

The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites globally. Key Responsibilities - Management Review Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content. Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA). Lead preparation of Management Review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items. Inspections and Compliance Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence. Actively contribute during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts. Lead Site Master File updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows. Technical Writing and Data Analytics Lead authoring and workflow coordination for periodic quality trend reports and related documentation. Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards. Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards. Preferred Qualifications Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles. Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred. Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights. Familiarity with electronic quality systems (e.g., Veeva, TrackWise, SAP-QM, LIMS) and documentation practices. Excellent verbal and written communication skills, including experience presenting to senior leaders. Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting. Core Competencies Leadership in Quality Governance (e.g., Management Review) Inspection Readiness and Compliance Assurance Quality Data Visualization, Interpretation and Analytics Technical Document Drafting and Workflow Ownership Cross-Functional Stakeholder Engagement Continuous Improvement Mindset Basic Qualifications and Experience: Master’s degree with 8-13 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Position Summary: The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. The Specialist QA will leverage industry, technical, and quality systems knowledge to provide support of product expiry management processes, product complaints processes, disposition manager training, and fulfillment of disposition related data requests across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally. Key Responsibilities DSI/DS/DP material shelf-life extension Executing the GMP process to extend expiration dates for clinical and commercial products produced at Amgen. Updating batch product expiration dates in the Amgen SAP inventory management system. Evaluating (approve or reject) expiry-SAF forms (expiry stability assessment forms). Disposition Support of Partner Requests Support requests made by Amgen partners for data and information related to their partnered product batches manufactured at Amgen sites. Data recovery from systems including, but not limited to, manufacturing execution system electronic batch records, the quality control laboratory information system, the regulatory information management system, and the Amgen enterprise resource management system (SAP). Uploading and communication of collected data to Amgen partners. COA Generation, special requests after disposition Generation and provision of Certificate of Analysis (CofA) records for Amgen drug substance, drug product, or final drug product batches. Uploading and communication of collected documentation to requestor (i.e. Amgen partners, regulatory compliance to support RTQs, process development). Disposition Manager Training Execution and delivery of quality systems training to new disposition managers across the Amgen network via virtual meetings. Training subject matter to include use of quality systems applied to execute the disposition process (i.e. ERP/SAP, MES/EBR, ARRS, LIMS, TW, CDOCS, DQMS, Kneat, etc.) Maintenance and revision of training document materials in the controlled documents management system (CDOCs). Product Complaints Execution of the drug substance, drug product, and final drug product complaint full batch record review process. Assessing electronic batch record (EBRs) documentation in the manufacturing execution system (MES) to identify any potential issues relevant to the complaint. Recording the results of the complaints batch record assessment in the Bioconnect quality system. Preferred Qualifications Experience in project management and related systems Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred. Excellent verbal and written communication skills Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting. Experience in manufacturing environments Core Competencies Experience working in a regulated environment with knowledge of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements. Experience working with Quality Systems that may include enterprise resource planning (ERP/SAP), regulatory information management (RIM), controlled document management (CDOCS), change control (QMTS), deviation (DQMS), and quality control laboratory information management systems (LIMS). Experienced in staff training and development. Technical Document Drafting and Workflow Ownership Basic Qualifications and Experience : Master’s degree with 8-12 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.

About Amgen Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. About The Role Role Description: In this vital role, you will lead the Amgen India, Quality Control Technical Resources Team. This is a unique opportunity to support the global Quality Control network and to learn about the testing of Amgen products through various stages of the product lifecycle. In addition, as this is a newly formed team, the Senior Manager will have the opportunity to develop new business processes and to strategically develop the team structure. The QC Technical Resources team will primarily provide centralized document management support for the global QC Network. This will include the creation and/or revision of controlled documents within Amgen’s enterprise document management system for a variety of QC processes. The Senior Manager Quality Control will provide management oversight of this team while fostering a culture of innovation, quality and collaboration. The Senior Manager will report directly to Amgen India Quality Leadership. This candidate will primarily work during regular working hours (9 AM – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally. Roles & Responsibilities: The Senior Manager Quality Control will be accountable for the following activities: Daily management of the Quality Control Technical Resources team Responsible for organizing team resources to ensure that agreed upon due dates are met for QC Network requests Responsible for creating and maintaining business processes and tools that will facilitate the management and visibility of QC network requests Responsible for ensuring that the Technical Resources team has access to the required laboratory information management and enterprise systems needed to carry out document management tasks (for example, LIMS, electronic laboratory notebook). Responsible for leading issue resolution and problem-solving exercises within the team and cross-functionally, as needed Support staff training, career development and performance management Responsible for ensuring compliance with safety guidelines, cGMPs and other applicable regulatory requirements. Additional Responsibilities: Participate in Amgen global network teams Establish and enable LEAN principles across area of responsibility Establish and enable department goals, strategies and KPIs Champion site and QC global process improvements Interfaces with management on significant matters, often requiring the coordination of activity across organizational units Plans and organizes project assignments of substantial variety and complexity Translates complex data into actionable information and applies strong technical knowledge to meet business objectives Identifies process gaps, introduces innovative solutions, and leads operational excellence projects to improve efficiency and productivity, while decreasing expense/operating costs. Leads root cause analysis discussions for more complex problems to develop and efficiently implement effective permanent solutions. Basic Qualifications and Experience: Master’s degree with 12-16 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience AND 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Functional Skills: Must-Have Skills: Experience working and leading teams in a cGMP laboratory environment. Strong technical writing skills within a highly regulated environment. Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control. Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources. Good-to-Have Skills: Track record of building or participating as a member of high performing team. Experience with various laboratory computer systems and applications. Strong leadership and negotiation skills with a demonstrated ability to influence different styles. Demonstrated innovative thinking and ability to transform work organizations. Exposure to Operational Excellence initiatives. Understanding of quality management systems and quality control processes related to drug substance and drug product for clinical and commercial operations. Demonstrated ability to navigate through ambiguity and provide structured problem solving. Demonstrated ability to coordinate multi-functional project teams and deliver on schedule. Demonstrated ability to coordinate and lead cross-functional teams. Demonstrated ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organization. Demonstrated skills in staff motivation, coaching/mentoring and professional development. Great teammate who can collaborate and provide leadership through influence to achieve the required results. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Role & responsibilities Production chemist and QC chemist Preferred candidate profile HPLC,GC wet lab,BPR,BATCH PLAN,REACTORS,ANALYSIS,WET LAB,INSTRUMENTATION, Perks and benefits As per company norms

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Position Summary: The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. The Specialist QA will leverage industry, technical, and quality systems knowledge to provide support of product expiry management processes, product complaints processes, disposition manager training, and fulfillment of disposition related data requests across the network. The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions. This candidate will primarily work during regular working hours (9 am – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally. Key Responsibilities DSI/DS/DP material shelf-life extension Executing the GMP process to extend expiration dates for clinical and commercial products produced at Amgen. Updating batch product expiration dates in the Amgen SAP inventory management system. Evaluating (approve or reject) expiry-SAF forms (expiry stability assessment forms). Disposition Support of Partner Requests Support requests made by Amgen partners for data and information related to their partnered product batches manufactured at Amgen sites. Data recovery from systems including, but not limited to, manufacturing execution system electronic batch records, the quality control laboratory information system, the regulatory information management system, and the Amgen enterprise resource management system (SAP). Uploading and communication of collected data to Amgen partners. COA Generation, special requests after disposition Generation and provision of Certificate of Analysis (CofA) records for Amgen drug substance, drug product, or final drug product batches. Uploading and communication of collected documentation to requestor (i.e. Amgen partners, regulatory compliance to support RTQs, process development). Disposition Manager Training Execution and delivery of quality systems training to new disposition managers across the Amgen network via virtual meetings. Training subject matter to include use of quality systems applied to execute the disposition process (i.e. ERP/SAP, MES/EBR, ARRS, LIMS, TW, CDOCS, DQMS, Kneat, etc.) Maintenance and revision of training document materials in the controlled documents management system (CDOCs). Product Complaints Execution of the drug substance, drug product, and final drug product complaint full batch record review process. Assessing electronic batch record (EBRs) documentation in the manufacturing execution system (MES) to identify any potential issues relevant to the complaint. Recording the results of the complaints batch record assessment in the Bioconnect quality system. Preferred Qualifications Experience in project management and related systems Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred. Excellent verbal and written communication skills Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting. Experience in manufacturing environments Core Competencies Experience working in a regulated environment with knowledge of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements. Experience working with Quality Systems that may include enterprise resource planning (ERP/SAP), regulatory information management (RIM), controlled document management (CDOCS), change control (QMTS), deviation (DQMS), and quality control laboratory information management systems (LIMS). Experienced in staff training and development. Technical Document Drafting and Workflow Ownership Basic Qualifications and Experience : Master’s degree with 8-12 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: In this vital role, you will lead the Amgen India, Quality Control Technical Resources Team. This is a unique opportunity to support the global Quality Control network and to learn about the testing of Amgen products through various stages of the product lifecycle. In addition, as this is a newly formed team, the Senior Manager will have the opportunity to develop new business processes and to strategically develop the team structure. The QC Technical Resources team will primarily provide centralized document management support for the global QC Network. This will include the creation and/or revision of controlled documents within Amgen’s enterprise document management system for a variety of QC processes. The Senior Manager Quality Control will provide management oversight of this team while fostering a culture of innovation, quality and collaboration. The Senior Manager will report directly to Amgen India Quality Leadership. This candidate will primarily work during regular working hours (9 AM – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally. Roles & Responsibilities: The Senior Manager Quality Control will be accountable for the following activities: Daily management of the Quality Control Technical Resources team Responsible for organizing team resources to ensure that agreed upon due dates are met for QC Network requests Responsible for creating and maintaining business processes and tools that will facilitate the management and visibility of QC network requests Responsible for ensuring that the Technical Resources team has access to the required laboratory information management and enterprise systems needed to carry out document management tasks (for example, LIMS, electronic laboratory notebook). Responsible for leading issue resolution and problem-solving exercises within the team and cross-functionally, as needed Support staff training, career development and performance management Responsible for ensuring compliance with safety guidelines, cGMPs and other applicable regulatory requirements. Additional Responsibilities: Participate in Amgen global network teams Establish and enable LEAN principles across area of responsibility Establish and enable department goals, strategies and KPIs Champion site and QC global process improvements Interfaces with management on significant matters, often requiring the coordination of activity across organizational units Plans and organizes project assignments of substantial variety and complexity Translates complex data into actionable information and applies strong technical knowledge to meet business objectives Identifies process gaps, introduces innovative solutions, and leads operational excellence projects to improve efficiency and productivity, while decreasing expense/operating costs. Leads root cause analysis discussions for more complex problems to develop and efficiently implement effective permanent solutions. Basic Qualifications and Experience: Master’s degree with 12-16 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience AND 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Functional Skills: Must-Have Skills: Experience working and leading teams in a cGMP laboratory environment. Strong technical writing skills within a highly regulated environment. Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control. Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources. Good-to-Have Skills: Track record of building or participating as a member of high performing team. Experience with various laboratory computer systems and applications. Strong leadership and negotiation skills with a demonstrated ability to influence different styles. Demonstrated innovative thinking and ability to transform work organizations. Exposure to Operational Excellence initiatives. Understanding of quality management systems and quality control processes related to drug substance and drug product for clinical and commercial operations. Demonstrated ability to navigate through ambiguity and provide structured problem solving. Demonstrated ability to coordinate multi-functional project teams and deliver on schedule. Demonstrated ability to coordinate and lead cross-functional teams. Demonstrated ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organization. Demonstrated skills in staff motivation, coaching/mentoring and professional development. Great teammate who can collaborate and provide leadership through influence to achieve the required results. EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

QA Technical Specialist The AIN QA Technical Specialist plays a critical role in advancing Quality Assurance initiatives across the Quality Operations Network, with a particular focus on Management Review, Inspections and Compliance, and Technical Writing & Data Analytics. This role provides operational support, technical leadership, and cross-functional collaboration to ensure compliance, continuous improvement, and data-driven decision making in support of the Quality Management System (QMS). The position will be responsible for tasks including the key responsibilities documented below and other technical quality-related job functions. This candidate will primarily work during regular working hours (9 AM – 6 PM local time) to enable the business in delivering Amgen’s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will also lead the remote support from AIN to Amgen sites globally. Key Responsibilities - Management Review Coordinate and manage all logistics related to Site Management Review, including compiling metrics, maintaining and updating Smartsheet trackers, and preparing content. Perform site-level and cross-site trend analysis (as applicable) using key quality metrics; identify trends and collaborate with site stakeholders to implement corrective and preventive actions (CAPA). Lead preparation of Management Review meetings, ensuring comprehensive data presentation creation, documentation of meeting minutes, and follow-up on action items. Inspections and Compliance Support readiness and response for internal and external inspections, including generation of pre-inspection documents such as deviation lists, change controls, and supporting evidence. Actively contribute during inspections by managing information requests, facilitating document electronic retrieval, and preparing responses in collaboration with subject matter experts. Lead Site Master File updates by coordinating content input from cross-functional stakeholders, drafting revisions, and managing review and approval workflows. Technical Writing and Data Analytics Lead authoring and workflow coordination for periodic quality trend reports and related documentation. Generate deviation summary reports to support product and process monitoring efforts, ensuring accuracy and consistency with cGMP standards. Drive quality risk assessments, providing technical leadership in risk identification, analysis, and mitigation planning in alignment with standards. Preferred Qualifications Demonstrated experience in a GMP-compliant environment with working knowledge of inspection protocols, site audits, and quality risk management principles. Proficiency in technical writing and data visualization tools; experience with Smartsheet, Tableau, or equivalent platforms preferred. Strong analytical skills with the ability to interpret data trends and drive improvements based on quality insights. Familiarity with electronic quality systems (e.g., Veeva, TrackWise, SAP-QM, LIMS) and documentation practices. Excellent verbal and written communication skills, including experience presenting to senior leaders. Proven ability to lead and collaborate within cross-functional teams in a dynamic, fast-paced setting. Core Competencies Leadership in Quality Governance (e.g., Management Review) Inspection Readiness and Compliance Assurance Quality Data Visualization, Interpretation and Analytics Technical Document Drafting and Workflow Ownership Cross-Functional Stakeholder Engagement Continuous Improvement Mindset Basic Qualifications and Experience: Master’s degree with 8-13 years of Pharma and Biotech commercial or clinical manufacturing Quality experience.

Job Title: Analyst - Analyst - Labware LIMS GCL - C3 Introduction To Role Are you ready to disrupt an industry and change lives? As Labware LIMS Analyst , you'll play a pivotal role in transforming our ability to develop life-changing medicines. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. You'll be empowered to perform at your peak, combining innovative science with leading digital technology platforms and data. With a passion for impacting lives through data, analytics, AI, machine learning, and more, you'll be part of a team that drives cross-company change to disrupt the entire industry. Accountabilities The main responsibilities of the role are to: Ensure optimum performance and stability of Labware LIMS system as part of Laboratory Quality Systems for AstraZeneca Operations, including providing workarounds and identifying areas for improvement or solutions to permanently address the issue. Provide 2nd/3rd line support (technical queries, bug fixes, and small enhancements relating to application and platform), aligning with AstraZeneca standards, and change control procedures. Take ownership of issues from delivery or issue resolution or escalation, as appropriate. Support development activities by helping in code build and deployment, tool configuration management and administration, application environment setup, and change and release management. Demonstrated ability to apply technical knowledge to multiple systems and support multiple business groups. Develop specialist knowledge in relevant systems, documenting and sharing that knowledge, as required, with global teams. Liaise with multiple stake holders including users, infrastructure/middleware teams, 3rd party software vendors for resolving issues and potential process improvements. Train, guide, and mentor new hires in the team. Essential Skills/Experience 3-5 years of experience in application support and maintenance (L2/L3 support) +3 years of experience working with LabWare LIMS V8. Strong Knowledge of the LIMS Basic programming language. Experience in Windows/UNIX application environment and understanding of client-server / distributed computing concepts. Experience in IT Service Management & Solution Delivery (Scrum/DevOps exp. preferred) Basic understanding of session virtualization concepts, and exposure to Citrix working environments. Strong knowledge of Incident, Problem, Change, and Release management processes. Demonstrated ability to apply technical knowledge to multiple systems and support multiple business groups. Development and fix experience with MS SQL Server. Development and fix experience with Oracle 12c or higher version. Good understanding of Microsoft IIS/Web Services (IIS 6.0, IIS 5.0) 1-2 years of experience managing projects following agile methodologies (SCRUM) Basic knowledge in DevOps. Desirable Skills/Experience Familiarity with life sciences (Pharma) domain concepts, workflow, and terminology Good knowledge of regulatory requirements including GMP and GxP. Exposure to system validation in the GxP systems. Experience working in global work teams. Experience in setting up and managing application environments. The mindset to support business-critical applications. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca is where innovation meets impact! Our diverse team works inclusively across international boundaries to lead change. We couple technology with an inclusive mindset to develop a leading ecosystem. Here, you can explore new solutions holistically, building partnerships inside and out. We drive simplicity and efficiencies that make a real difference. With investment behind us, there's no slowing us down. The variety of work we do is incredible—always different and interesting. Join us to work on cutting-edge technologies and feed your passion for data, analytics, AI, machine learning, and more. Ready to make a meaningful impact? Apply now to join our dynamic team! Date Posted 21-Jul-2025 Closing Date 27-Jul-2025 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Location: Ankleshwar Department: Quality Control Experience: 4 to 7 years Position : Executive Job Description: We are looking for a skilled HPLC Analyst (Executive QC) who will be responsible for ensuring quality compliance in laboratory testing of pharmaceutical raw materials, intermediates, finished goods, and stability samples. Key Responsibilities: Adhere to GLP (Good Laboratory Practices) and laboratory safety protocols . Perform routine and stability analysis of raw materials, intermediates, finished products, in-process samples , returned goods, hold time studies using HPLC . Maintain online documentation and ensure CFR 21 Part 11 compliance. Record and maintain analytical results in worksheets and LIMS modules. Conduct analysis as per current STP, SOPs, and specifications . Prepare and standardize reagents, solutions, and mobile phases as per requirement. Ensure column performance is tracked and updated in column logbooks . Maintain instrument logbooks , calibration schedules, and instrument history records . Participate in analytical method transfer (AMT) with A.R. laboratory teams. Prepare stability protocols and reports , and perform stability sample analysis . Monitor temperature & humidity of laboratory, refrigerators, and working standard chambers. Report and initiate investigations for OOS, OOT, Deviation, QI, NQI, and discrepancies in analysis. Follow Good Chromatographic Practices for integration and review of chromatographic data. Ensure data integrity and compliance during all analytical activities. Communicate and coordinate with stores for urgent material analysis. Avoid solvent/chemical wastage and ensure clean laboratory operations. Interested candidate please fill the below given link: https://docs.google.com/forms/d/e/1FAIpQLScDxs_rRkTFo3l4kQNsy9oij5XXDEi4ztPPsIbwxHvGaLaKbA/viewform?usp=header

A. MICROBIOLOGY DEPARTMENT 1. Laboratory Management & Compliance 1.1 Oversee daily operations, including staff management, scheduling, and resource allocation. Manage the day-to-day activities of the lab, ensuring efficient workflow. This includes supervising staff, creating schedules, and allocating resources like equipment and materials to meet operational needs and deadlines. 1.2 Ensure all laboratory activities comply with ISO 17025:2017 and relevant regulations. Maintain strict adherence to quality standards and regulatory requirements. This involves implementing and monitoring procedures to guarantee that all tests, calibrations, and lab practices meet the rigorous specifications of the ISO 17025:2017 standard. 1.3 Develop and implement laboratory policies, procedures, and standard operating procedures (SOPs) to maintain operational efficiency. Create and enforce clear guidelines for all lab processes. These policies and SOPs standardize workflows, improve consistency, and ensure that all tasks are performed accurately and efficiently. 1.4 Collaborate with the Business Development (BD) team to identify and upscale low-utilized areas within the scope of laboratory accreditation, ensuring optimal resource allocation and enhanced service offerings. Work with the BD team to find untapped opportunities within the lab's accredited testing capabilities. This collaboration helps to maximize the use of existing resources and expand the range of services offered to clients. 1.5 Evaluate and make strategic decisions regarding scope expansion and trimming; for scope expansion, plan and oversee Proficiency Testing (PT), Inter-Laboratory Comparisons (ILC), and Internal Quality Audits (IQA) to ensure compliance and readiness for new testing areas. Assess which services to add or remove based on market needs and business strategy. When expanding, meticulously plan and manage quality assurance activities like PT, ILC, and IQA to confirm the lab's technical competence and readiness for new accredited testing areas. 1.6 Provide technical expertise to the BD team by guiding the development of new microbiological test methods and confirming their feasibility to meet client needs, market demands, and accreditation standards. Offer technical advice to the BD team for creating new testing solutions. This involves ensuring that new microbiological methods are scientifically sound, practical to implement, and will satisfy client requirements while also meeting accreditation standards. 1.7 Estimate the costs associated with new method development, including resources, equipment, reagents, personnel, validation studies, etc., to support budgeting and decision-making. Calculate the financial investment required for new test methods. This includes a detailed cost analysis of all necessary resources, from equipment and chemicals to personnel and validation studies, to support informed budget planning and strategic decision-making. 1.8 Oversee website improvement, manage social media posts and update, and develop engaging content for WhatsApp pamphlets, brochures, "Do You Know" (DYK) series, blogs, and similar platforms to boost visibility and communication. Manage the lab's online presence and public outreach efforts. This includes improving the website, creating social media content, and developing informative materials to increase visibility, communicate with clients, and build a strong brand presence. 2. Quality Assurance and Compliance 2.1 Ensure adherence to food safety regulations, such as those from the FSSAI, EIC & APEDA. Maintain strict compliance with national and international food safety standards. 2.2 Conduct internal audits, manage non-conformances, and implement corrective and preventive actions (CAPAs). Perform regular internal checks to assess compliance with quality management systems. This process includes identifying any deviations or non-conformances, systematically managing them, and then implementing corrective and preventive actions to resolve the root causes and prevent recurrence. 2.3 Coordinate external audits and assessments by accreditation bodies and customers. Serve as the primary point of contact for all external quality and compliance audits. This involves scheduling, preparing for, and facilitating assessments by third-party accreditation bodies and client representatives to demonstrate the lab's competence and adherence to required standards. 3. Personnel Management 3.1 Screening of resumes provided by human resource dept., shortlisting & selection of personnel through video conferencing or face to face interview. Manage the recruitment process by reviewing candidate resumes and shortlisting top talent. Conduct interviews, whether online or in person, to select the most suitable individuals for the team based on their qualifications and potential. 3.2 Recruit, train, and develop laboratory staff to ensure competency in their roles. 3.3 Verify the internal and external training plan of the employees prepared by deputy and plan the timely execution of trainings. 3.4 Conduct performance evaluations and provide feedback for probation confirmation of the employees. Assess the performance of new employees during their probationary period. Provide constructive feedback on their work and make informed decisions on whether to confirm their employment based on their performance and fit within the team. 3.5 Support continuous professional development of the personnels. 3.6 Foster a culture of safety, quality, and continuous improvement. Create a work environment where a commitment to safety and quality is a top priority for everyone. Promote a mindset of constant improvement by encouraging staff to identify better ways to perform tasks and solve problems. 3.7 Ensure staff are trained in ISO 17025:2017 requirements and laboratory safety protocols. Provide mandatory training for all staff on the key principles of the ISO 17025 standard to guarantee compliance and quality in all lab operations. Additionally, ensure everyone is fully trained on essential safety protocols to maintain a secure working environment. 4. Technical Oversight 4.1 Provide technical leadership for microbiological testing methodologies for incoming laboratory samples. 4.2 Stay updated on advancements in technologies and regulatory requirements. 4.3 Plan and oversee method validation, method verification, measurement of uncertainty, proficiency testing, and metrological traceability. Systematically plan and manage all quality assurance activities to ensure the reliability of test results. This involves validating new methods, verifying existing ones, calculating measurement uncertainty, participating in proficiency testing, and establishing metrological traceability for all measurements. 4.4 Reviewing and verifying raw data, as well as authorization of Test-Reports. Meticulously examine and verify all raw data generated from laboratory tests to ensure its accuracy and integrity. After a thorough review, authorize and sign off on the final test reports, confirming their validity and readiness for release to clients. 5. Stakeholder Communication 5.1 Liaise with clients, regulatory bodies, and accreditation bodies to meet expectations. Serve as the primary point of contact for all external stakeholders. This includes building and maintaining strong relationships with clients to understand their needs, and working with regulatory and accreditation bodies to ensure the lab meets all required standards and expectations. 5.2 Represent the laboratory in meetings, conferences, and industry forums. Act as a key spokesperson for the lab at various professional gatherings. This involves participating in meetings, presenting at conferences, and attending industry forums to promote the lab's services, share expertise, and stay current on market trends. 6. Budget and Resource Management 6.1 Manage the laboratory budget, including equipment procurement, maintenance, and calibration. 6.2 Ensure efficient resource use to meet operational needs while maintaining cost-effectiveness. to 6.3 Plan and implement upgrades to laboratory infrastructure and technology. 7. Risk Management 7.1 Identify and mitigate risks related to laboratory operations, such as contamination or equipment failures. Proactively identify potential threats to laboratory integrity and workflow. This involves implementing robust protocols and procedures to prevent risks like sample contamination or equipment malfunctions, ensuring the reliability of all test results and operational continuity. 7.2 Ensure proper handling, storage, and disposal of food samples and hazardous materials. Establish and enforce strict safety and quality protocols for all materials in the lab. This includes meticulously managing the entire lifecycle of food samples and hazardous substances, from secure storage to safe and compliant disposal. Skills and Competencies • Education: Master’s degree or Ph.D. in Microbiology, Biotechnology, or a related field. • Leadership and Team Management: Ability to lead and motivate a diverse team. • Technical Expertise: Deep knowledge of microbiological food testing techniques. • Regulatory Compliance: Familiarity with food safety standards (e.g., FDA, FSSAI, Codex Alimentarius). • Communication: Excellent verbal and written skills for client and regulatory interactions. • Problem-Solving: Strong analytical skills to address operational and technical challenges. • Project Management: Ability to manage multiple priorities effectively. • Software Proficiency: Experience with laboratory information management systems (LIMS) and relevant software. Additional Requirements • Ability to work in a fast-paced environment and meet tight deadlines. • Commitment to maintaining high standards of laboratory safety and quality. • Dedication to fostering continuous improvement and innovation.

Job Title Business Analyst – Oil & Gas Digital Solutions (5–7 years exp.) Location Remote, Ready to travel based on project need Role Objective Bridge business needs and engineering execution for digital products in the Oil & Gas sector . You will turn domain‑specific challenges - across exploration, drilling, production, midstream operations or downstream refining - into clear, actionable requirements that help our teams deliver high‑value software. Proven experience analysing Oil & Gas processes and at least one end‑to‑end release of a digital solution are must‑haves. Key Responsibilities Discover & Define Lead discovery sessions with geoscientists, production engineers, and field supervisors to capture workflows, data points and success metrics. Map current‑state processes (well‑to‑tank flows, maintenance work orders) and design future‑state journeys that reduce downtime and improve safety or throughput. Document detailed business requirements, user stories and acceptance criteria in plain language that both engineers and domain experts understand. Analyse Data & Validate Solutions Work with data engineers to specify data sources - SCADA, PI historians, LIMS, ERP/MMS and define data‑quality checks. Thorough analysis to validate assumptions and establish baselines for KPIs such as OEE, MTBF, NPT or emissions intensity. Partner with QA to design test scenarios that reflect real‑world edge cases. Support Agile Delivery Groom and prioritise the backlog; ensure stories are “Ready” before sprint planning. Clarify domain questions for developers and track resolution of defects or change requests. Maintain traceability from requirements to deployed functionality and regulatory mandates. Engage Stakeholders Present sprint reviews to offshore/onshore asset teams, IT leadership and client CXOs. Prepare concise artefacts - process maps, data dictionaries, training decks—to drive user adoption. Champion business value throughout the project lifecycle, flagging scope creep and recommending phased delivery when needed. Continuous Improvement & Knowledge Sharing Stay current with digital oilfield trends (predictive maintenance, real‑time production optimisation, digital twins). Share learnings via internal brown‑bags and contribute to the Oil & Gas practice playbook. Expected Results Key Metric Target & Measurement Method Business Impact On‑time delivery ≥ 90 % of backlog items accepted by the business on or before the sprint/release commitment date. Keeps project timelines predictable and avoids costly rig‑ or plant‑schedule overruns. Requirements Accuracy ≤ 5 % of stories returned for re‑work due to unclear or missing acceptance criteria. Minimises churn for engineering and reduces defect leakage into UAT/production. Stakeholder satisfaction Average CSAT ≥ 4.2 / 5 across quarterly surveys of asset teams, IT leaders and field users. Confirms the product is solving real operational pain points. Domain knowledge depth Peer review ≥ 80 % on key Oil & Gas concepts (well lifecycle, OEE, emissions KPIs, industry regulations). Ensures the analyst can translate complex field processes into actionable requirements. Business value realisation Document at least two case studies showing measurable impact (e.g., 2 % uptime gain, 10 % work‑order cycle‑time reduction, $X OPEX saved). Demonstrates ROI and supports follow‑on engagements. Essential Qualifications & Skills Education Bachelor’s degree in Engineering / IT required . MBA or relevant master’s preferred . Professional Experience 5–7 years total in business‑analysis or techno‑functional roles delivering digital solutions. Minimum 3 years hands‑on work in Oil & Gas (upstream, midstream or downstream) with clear exposure to production operations, asset maintenance or plant/refinery workflows, or at least in any other asset heavy industry. Participated in at least one end‑to‑end product or system launch ( concept → deployment). Consulting, SI or multi‑client product‑engineering background strongly valued. Core Skills Skilled in Agile delivery: backlog grooming, INVEST stories, Definition of Ready/Done. Ability to read and interpret P&IDs, equipment hierarchies, well schematics and relevant industry data standards (e.g., ISO 14224, OSDU). Proficient with requirements and data tools: Jira/Azure DevOps, Visio/Lucidchart, SQL or BI platforms (Power BI/Tableau). Clear, persuasive communicator; comfortable presenting to CXOs and field personnel alike. Behavioural Competencies Domain Curiosity – digs deep to understand field realities, safety regulations and production economics. Structured Thinking – converts complex operations into well‑organised requirements. Collaboration – builds trust with field staff and development teams alike. Ownership – follows features from idea to post‑launch feedback. Adaptability – balances long‑term vision with on‑the‑ground constraints and changing priorities. Join Us Codvo is a fast‑growing, empathy‑led technology company where domain expertise meets cutting‑edge engineering. If you’re passionate about making Oil & Gas operations safer, cleaner and more efficient through software—and you enjoy turning real‑world challenges into clear product requirements—we’d love to meet you.

As a valued member of our team, you will play a crucial role in ensuring the delivery of safe and effective products to patients. Your dedication to quality, coupled with our customer-oriented culture, rooted in science and compliance, will directly impact patient care. You will contribute to upholding a quality culture that evolves to meet patient needs, guaranteeing that our products meet the highest safety and efficacy standards. In this role, your responsibilities will include creating, reviewing, and approving test method transfer and validation protocols, reports, and equipment qualification records. You will maintain compliance with Good Manufacturing Practices in Quality Control and Stability laboratories, support media preparation, handle Bio ball cultures, and conduct microbiology-related investigations. Additionally, you will perform testing on various samples, manage Laboratory Information Management System builds, review laboratory data, serve on cross-functional teams, conduct safety inspections, participate in investigations, recommend corrective actions, and provide training to junior colleagues. To excel in this role, you must possess a Master's degree in microbiology with a minimum of 6 years of relevant experience. Strong technical skills in method validation and testing, along with experience in microbiological testing of water, are essential. A deep understanding of pharmaceutical manufacturing, packaging, and quality assurance operations, coupled with attention to detail and robust knowledge of quality systems, will be key to your success. Effective written and verbal communication, interpersonal skills, and familiarity with research unit clinical and analytical laboratory environments are also necessary. Preferred qualifications include relevant pharmaceutical experience, a strong understanding of computer system hardware, infrastructure, and networks, as well as experience with Laboratory Information Management Systems (LIMS). Proficiency in data analysis and interpretation, knowledge of regulatory requirements and guidelines, strong problem-solving abilities, effective time management, organizational skills, and the ability to mentor and train junior colleagues are considered advantageous. Your work location will be on premise, and Pfizer is proud to be an equal opportunity employer that complies with all applicable equal employment opportunity legislation in each jurisdiction where it operates. Join us in upholding quality assurance and control to make a meaningful difference in patient care.,

About The Job Company Context Sanofi's strategic direction is to standardize processes across sites, embrace digital transformation of its Manufacturing & Supply perimeter, simplify its current solution landscape, and leverage advanced technologies to bring business value. The MARS (MES Accelerated Roadmap @ Sanofi) program aims to implement Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). This program will transform Sanofi plants, improving compliance, cost, and cycle time performance. Over recent years, Sanofi has deployed various Production sites across GBUs (multiple pharmaceutical processes, Weighing & Dispensing & full MES), with a second wave currently in motion. This represents a strategic opportunity for Manufacturing & Supply Transformation to: Design standardized end-to-end processes to generate business value and deliver best-in-class solutions to industrial sites, with high focus on electronic batch record management & review by exception process Deliver innovative "state of the art" tools enabling performance for manufacturing processes Allow new generation of deployment – more Agile & business centric Maintain robust and highly available solutions to operate industrial processes efficiently Role Overview: The MES DevOps Manager is responsible for leading the delivery, design/ build/ implementation and continuous enhancement of global end-to-end Manufacturing Execution System (MES) solutions at Sanofi. This role focuses on team mgt/leadership, technical mgt/expertise, and delivery excellence to ensure MES configurations meet the needs of Sanofi's manufacturing operations while adhering to quality, regulatory, and cybersecurity requirements. The manager will manage a team (functionally, technically and administratively) of MES DevOps Engineers and MBR developers, take the ownership/leadership of technical delivery of the team to answer to the requirements of manufacturing sites and align with the expectations of the product owner (Siemens OPCenter) and capability manager. Main Responsibilities Systems & Processes in Scope Main MES Systems: Siemens MES Opcenter Execution Pharma Product Siemens Equipment logbook Pharma Main platform : Mendix Business Processes Covered: Master data management (items, user rights, equipment, locations, work orders) Master batch record design & approval (including workflows) Master batch record review & approval (by Exception) Templates for elogbook Instructions on Operating Text Production execution Weighing & Dispensing Communication to equipment or SCADA systems Equipment management Material flow management Traceability / Genealogy Labelling Reporting Interface with ERP, quality, logistics & shopfloor systems (LIMS, Documentation, Deviation management, Serialization, eOEE) Key Responsibilities: 1. Team Leadership and Management: Lead and manage a team of MES DevOps Engineers and MBR developers Facilitate onboarding and integration of team members as they join the organization Drive knowledge building and skill development within the team. Foster a culture of continuous learning and best practice sharing among team members Ensure team members are prepared and able to travel to Sanofi industrial sites globally (Europe, NA, Asia) where MES is in use. And ensure team members are developing a closed partnerships with sites users & business system owners to guarantee a full understanding of business requirements, stakes, challenges, constraints & ultimately build efficient solutions Managing the priorities of the team, Facilitating resource allocation and management for various MES projects across Digital Manufacturing & Supply Taking the ownership/leadership of technical delivery of the team, ensuring knowledge transfer, and contributing to operational excellence to answer to the requirements of manufacturing sites and align with the expectations of the product owner (Siemens OPCenter) and capability manager. 2. Technical Expertise and Team Development: Assess and enhance the technical capabilities of the team Identify skill gaps and implement targeted training and development programs Establish mentoring relationships to accelerate team members' growth and expertise Create a collaborative environment that encourages innovation and problem-solving Ensure the team stays current with evolving MES technologies and industry best practices Develop leadership & accountability at each individual level 3. Technical Configuration and Solution Design: Oversee the design and build of MES configurations, ensuring alignment with standard market solutions and Sanofi best practices Coordinate / align with expectations of Product Owner for Siemens OPCenter to support configuration, implementation, and deployment projects Guide the team in developing MBRs, Process Instructions, blocks, and templates according to functional specifications Establish configuration strategies that leverage market solutions and align with industry best practices and Ensure configurations align with the Core model and operational excellence standards 4. Delivery and Quality of Services: Drive timely and high-quality delivery of configuration projects while maintaining robust, cost-effective solutions Establish and maintain delivery frameworks that ensure consistent, predictable outcomes Implement delivery metrics and KPIs to track performance, quality of service, and team productivity Lead risk mitigation strategies to address potential delivery challenges proactively Coordinate cross-functional implementation activities to ensure smooth deployment/ configurations across different industrial sites Ensure compliance with legal and regulatory requirements (GxP, Data Privacy, SOX, etc.) Establish delivery governance to maintain transparency and accountability throughout the delivery lifecycle Oversee the implementation of various MES projects, including product builds and data foundations, maintaining accountability for the results delivered by MES DevOps Engineers and MBR developers Work closely with product owners and across MES teams to develop and implement strategies supporting product build and configuration, delivery, implementation projects Ensuring optimal resource allocation and project outcomes 5. Operational Excellence and Continuous Improvement: Drive the implementation of best practices in MES configuration and development Identify opportunities for process optimization and efficiency improvements Lead initiatives to streamline workflows and enhance productivity Collaborate with cross-functional teams to align MES configuration with broader organizational goals Promote a culture of quality and continuous improvement within the team and across projects Develop culture of empowerment, ownership, Thoughtful risk taking 6. Stakeholder Management: Collaborate with MES Product Owner, Service manager, capability manager and lifecycle manager and users/ manufacturing sites Work with Enterprise Architects, solution architects, Quality and the Cybersecurity team to review & qualify configuration designs Communicate effectively with Digital management teams, staff, and business stakeholders Oversee trainings & knowledge transfer and best practice sharing between the team and sites Ensure the team provides effective functional & technical support throughout the solution lifecycle 7. Business Alignment and Innovation: Analyze business requirements for various processes, providing direction to challenge, consolidate, and develop solutions expandable to multi-business unit use cases Develop strategies to maximize customer satisfaction while minimizing build and maintenance costs and risks Guide the strategic evaluation of configuration options and assess/manage associated risks Remain current on technology trends and benchmark with other companies to bring innovative inputs to solutions Lead initiatives to evolve GxP Validation approaches to simplify and adapt to next-generation technologies Required Skills and Qualifications: Experience & Knowledge: 12+ years of work experience in Digital Manufacturing domain, with 8+ years of experience in MES, specifically Siemens OPCenter Execution Pharma and Siemens Equipment Logbook Strong team management experience with demonstrated success in leading and developing technical and functional teams Proven track record of successful delivery of complex technical solutions in regulated environments Demonstrated experience in managing delivery timelines, resources, and quality simultaneously Experience in multicultural, multilanguage environments and matrixed organizations Broad knowledge of manufacturing processes in pharmaceutical industrial plants Strong MES experience: market standards knowledge (solutions, technologies, integration, architecture) Experience & understanding of core product/model concept Technical Skills: Expertise in MES solutions: Siemens OPCenter Execution Pharma Strong knowledge of Manufacturing Execution Systems, including Master Batch Record and Review by Exception business processes Solid understanding of manufacturing processes in pharmaceutical plants Strong knowledge of pharma industry regulatory context (GxP) Knowledge of solution architecture, integration, and infrastructure technologies Knowledge of Automation layer (SCADA, DCS, PLCs, industrial protocols) Experience & knowledge of Mendix/ low-code platforms Knowledge of scripting (VB etc.) is a plus but not required Soft Skills: Strong leadership capabilities with proven ability to inspire and develop teams High degree of accountability and proactive problem-solving mindset Results-oriented approach with strong focus on delivery excellence Excellent interpersonal and communication skills Ability to build and maintain strong relationships across all organizational levels Customer-centric approach with focus on delivering value Collaborative team leader & player with experience in matrix organizations Change management expertise and ability to adapt to dynamic environments Strategic thinking with strong decision-making abilities Agile methodology practitioner Ability to manage competing priorities and resilience to deliver under pressure Education: Engineering degree or Master's in Computer Science or related field (or equivalent experience) MBA or equivalent business management qualification is a plus Language: Fluency in English, other languages are a plus Working Environment: Occasional travel requirement to manufacturing sites in Europe / North America/ Asia Global, matrix organization environment Must be able to work effectively across different time zones and cultures Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

About The Job Company Context Sanofi's strategic direction is to standardize processes across sites, embrace digital transformation of its Manufacturing & Supply perimeter, simplify its current solution landscape, and leverage advanced technologies to bring business value. The MARS (MES Accelerated Roadmap @ Sanofi) program aims to implement Computer-assisted batch review, enabled by the definition and roll-out of a core Manufacturing Execution System (MES). This program will transform Sanofi plants, improving compliance, cost, and cycle time performance. Over recent years, Sanofi has deployed various Production sites across GBUs (multiple pharmaceutical processes, Weighing & Dispensing & full MES), with a second wave currently in motion. This represents a strategic opportunity for Manufacturing & Supply Transformation to: Design standardized end-to-end processes to generate business value and deliver best-in-class solutions to industrial sites, with high focus on electronic batch record management & review by exception process Deliver innovative "state of the art" tools enabling performance for manufacturing processes Allow new generation of deployment – more Agile & business centric Maintain robust and highly available solutions to operate industrial processes efficiently Role Overview The Manufacturing Execution System (MES) DevOps Engineer drive the design, build, and lifecycle of global end-to-end MES solutions. You will ensure local configurations align with the Core model and operational excellence standards while guaranteeing and promoting the right usage of Sanofi Digital and Industrial standards for Processes, Applications, and Infrastructure environments. You will leverage the Digital Portfolio's Detail Design documents, catalogue of services, and existing Core building blocks while supporting sites in troubleshooting and remediation action plans. Working in close collaboration with MES Product Owners, MES DevOps Manager, MBR Developer, MES Full Stack Engineers, MES installers/developers, Product lines, local digital teams, Business Process Owners, Archetype leads, Site modelers, and Shopfloor experts, you will remain current on company standards, Digital industry practices, and emerging standards while contributing to Digital standards maintenance. Systems & Processes in Scope Main MES Systems: Siemens MES Opcenter Execution Pharma Product Siemens Equipment logbook Pharma Main platform : Mendix Business Processes Covered: Master data management (items, user rights, equipment, locations, work orders) Master batch record design & approval (including workflows) Master batch record review & approval (by Exception) Templates for elogbook Instructions for Operating Text Production execution Weighing & Dispensing Communication to equipment or SCADA systems Equipment management Material flow management Traceability / Genealogy Labelling Reporting Interface with ERP, quality, logistics & shopfloor systems (LIMS, Documentation, Deviation management, Serialization, eOEE) Main Responsibilities Key Responsibilities Understand business requirements (including analytics) for various processes, challenge, consolidate, and extrapolate them to design & build solutions expandable to multi-business unit use cases and plant configurations Maximize customer satisfaction while minimizing build and maintenance costs and risks associated with fulfillment of business needs Implement appropriate services to ensure optimal allocation of all available capabilities Evaluate impact analysis of solution options and assess/manage associated risks Conduct end-to-end business process analysis including integration with partner systems (ERP, shopfloor systems, automation layers), labelling technologies, and mobile technologies Stakeholder Management & Training Coordinate, inform, and ensure functional expertise in a matrix context Transfer know-how, experience, and best practices to sites Contribute to Digital skills development within your domain Provide functional & technical support during the full solution lifecycle and to the sites Ensure adoption and adequate use of solutions Deliver on-site training to manufacturing sites Delivery & Quality of Services Design and build MBRs, Process Instructions, blocks, and templates including Functional specifications Configure & implement core solutions as close to standard market solutions as possible, based on state-of-the-art best practices Aim to align processes and enable industrial efficiency across different Sanofi industrial sites Define appropriate design & build of solutions by adopting GxP validations Participate in regular design reviews with site modelers to ensure best practices are followed Perform or participate in regular MBR reviews for sites Ensure technical solutions comply with recommendations for Quality, Security, and Accessibility Lead the on-time delivery of projects while ensuring robust, cost-effective solutions Safeguard proper deployment of core solutions on different industrial sites Participate in defining indicators for performance and quality of service, monitor and communicate them Manage preventive/corrective maintenance for components Ensure standards and rules for Platform Management (Release management, Solution Documentation, Testing) are correctly understood and applied Manage incidents & corrective/preventive actions Strategy Development & Implementation Remain current on technology trends and benchmark with other companies and partners to bring innovative inputs to solutions, operating models, and strategy Collaborate with peers (Enterprise Architects, solution/ technical architects, Quality, Cybersecurity) to review and qualify solution design and/or introduction of new technology Explain/present architecture and technical matters in an understandable way to Digital management team, staff, and business stakeholders Break current GxP Validation established postulates to simplify and adapt to current and next-generation technologies & methodologies (Cloud, Service Management, Agile) About You Experience & Knowledge 8+ years of work experience in Digital for Manufacturing domain, with 5+ years of experience in MES, specifically Siemens OPCenter Execution Pharma and Siemens Equipment logbook Demonstrated experience in multicultural/multilanguage environments and matrixed organizations Broad knowledge of manufacturing processes in industrial plants Strong MES experience: market standards knowledge (solutions, technologies, integration, architecture), process industry within life science/pharmaceutical industries Experience & understanding of core product/model concept Successful and significant Project Management experience is a plus Technical Skills Expertise in MES solutions: Siemens OPCenter Execution Pharma and Siemens Equipment logbook Strong knowledge of Manufacturing Execution Systems, including Master Batch Record and Review by Exception business processes Solid understanding of manufacturing processes in pharmaceutical plants Strong knowledge of pharma industry regulatory context (GxP) Strong knowledge of Digital technologies & concepts Knowledge of Automation layer (SCADA, DCS, PLCs, industrial protocols) Good experience & knowledge of Mendix Knowledge of Scripting (VB/.Net) development & validation JSON development is a plus Knowledge of reporting tools (Power BI) is a plus Soft Skills Accountability and reliability Customer-driven mindset Fast learner, proactive, willing to apply change management Ability to deal with ambiguous situations Strong focus on value delivery, with ability to work autonomously on solution design Ownership and leadership within assigned scope Agile methodology practitioner Communication and interaction skills Ability to challenge, open-minded and active listening Ability to explain complex matters in a simple and understandable way Education Engineering degree or Master's in Computer Science or related field (or equivalent experience) Language Fluent in English, other languages are a plus Working Environment Travel requirement: 30% of time to manufacturing sites in Europe, North America & Asia Global, matrix organization environment Must be able to work effectively across different time zones and cultures Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

About The Job Context: As part of Sanofi's initiative to standardize processes and drive digital transformation across Manufacturing & Supply, this role is crucial in orchestrating the lifecycle management of MES systems, including the MARS (MES Accelerated Roadmap @ Sanofi) implementations across multiple production sites globally. Job Summary: The MES Lifecycle Manager drives the strategic planning and execution of MES installations, updates and migrations across Sanofi's industrial network and the lifecycle planning in alignment with the Product Owner Vision & product Roadmap. This role provides technical and strategic leadership in developing and implementing long-term strategies to optimize MES performance, reduce obsolescence, and align MES capabilities with Sanofi's digital transformation goals. Main Responsibilities Strategic MES Lifecycle Management: Develop and execute a comprehensive MES lifecycle planning/ strategy aligned with Sanofi's digital transformation objectives, Product Owner Vision & product Roadmap Orchestrate high-level planning of MES installations, updates, and migrations across global industrial sites Create and implement strategies to reduce system obsolescence and optimize MES performance across the network Lead and coordinate multiple concurrent MES lifecycle initiatives through effective coordination Implementation Strategy & Site Engagement: Establish strong collaboration and coordination with manufacturing sites for planning of updates, installations, and migrations Partner with site leadership to ensure MES lifecycle activities align with production schedules and business priorities Facilitate communication between digital teams and manufacturing sites to ensure mutual understanding of requirements and constraints Develop site-specific implementation strategies that minimize disruption to manufacturing operations Leadership & Projects/ initiatives oversight: Drive & coordinate multiple MES lifecycle initiatives, ensuring alignment with stakeholders, PO and objectives Establish effective governance practices to support MES lifecycle management Drive decision-making processes, balancing technical, business, and compliance considerations Apply project management approaches to ensure successful execution of MES lifecycle initiatives Develop roadmaps and timelines for MES lifecycle activities across sites Act as direct lead of external coordinators globally/ across the world Digital Transformation & Innovation: Spearhead the evolution of MES capabilities by leveraging emerging technologies such as AI, Cloud services, and DevOps Collaborate with leadership to define the future state of manufacturing systems and drive digital innovation Drive strategic initiatives to enhance integration between MES and other critical systems (ERP, SCADA, LIMS, etc.) Change Management: Guide change management efforts to ensure successful adoption of new MES technologies and processes Align diverse stakeholders across IT, Manufacturing, Quality, and Business units to support MES lifecycle initiatives Risk Management & Compliance: Develop risk management strategies for MES lifecycle planning, ensuring GxP compliance and data integrity Collaborate with Quality and Regulatory Affairs to ensure MES strategies meet evolving compliance requirements Foster relationships with key industry groups to stay abreast of emerging trends and regulations Monitor and report on initiative risks, issues, and mitigation strategies Required Qualifications: Master's degree in engineering, Computer Science, or related field 12+ years of experience in pharmaceutical manufacturing systems, with 8+ years' experience on MES, specifically Siemens Opcenter and Werum PAS-X Demonstrated experience in project & initiative management of complex technology initiatives in regulated environments Track record of successful coordination with manufacturing sites on technology implementations Deep understanding of pharmaceutical manufacturing processes and GxP regulations Strong knowledge of MES technologies and their integration with broader manufacturing and business systems Project Management Certification (eg PMP) and Scrum certification are desired Leadership & Soft Skills: Strategic thinking and ability to translate vision into actionable plans Strong interpersonal skills with ability to build and maintain relationships across all organizational levels Excellent project/ initiative coordination and stakeholder engagement capabilities Ability to influence without direct authority and align diverse groups across the organization Change management expertise with proven ability to drive organizational transformation Cultural awareness and sensitivity in global interactions Active listening and empathetic communication style Exceptional communication skills, including ability to articulate complex technical concepts to diverse audiences Strong facilitation skills for cross-functional meetings and workshops Diplomatic approach to stakeholder management Excellent negotiation and conflict resolution capabilities Adaptability and resilience in managing complex, evolving situations Calm and composed under pressure Proactive problem-solving mindset Technical Knowledge: Good understanding of MES solutions (e.g., Siemens Opcenter, Koerber PAS-X) Expertise in managing technology obsolescence, including lifecycle management & risk mitigation Strong knowledge of MES installation, migration, and update methodologies Familiarity with emerging technologies in manufacturing (AI, Cloud) Knowledge of integration approaches for complex manufacturing IT landscapes Knowledge and Experience of JIRA, Confluence Experience of project management methodology and tools – Microsoft Project Experience with system validation and qualification in GxP environments Knowledge of technology refresh strategies and implementation approaches Working Environment: Flexibility to contribute occasionally on operations out of working hours Occasional travel to manufacturing sites in Europe, NA and Asia Global, matrix organization environment Must be able to work effectively across different time zones and cultures Languages: Fluent in English; additional languages are a plus Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Pursue Progress . Discover Extraordinary . Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Employment Type : On Contract _ till December 2026 Role & responsibilities: Lead Global GxP relevant IT Projects. Perform Global Quality Approval and Release of GxP relevant IT System Validations Manage, create, implement and maintain of harmonized STADA Global GxP Computer Validation System (CSV) Governance. STADA Global Quality Expert and CSV Champion to provide support to local, cluster and global teams in IT Validations in compliance with Health Authority requirements. Lead STADA Global GxP relevant IT Projects Lead Quality and other Business Teams in IT System Projects to ensure compliance with Health Authority requirements, such as, GxP and Data Integrity Prepare in collaboration with STADA Global IT highest level of Validation Governance documents, such as Validation Plans, in compliance with CSV regulations. Lead success closure activities of all required GxP relevant documents that are required for releasing the Global IT system for use/production. Present Projects to STADA Global Leadership members, including TechOps and Global IT Senior Vice Presidents and Global Quality Leadership Team. Global Quality Approvals and Releases Approve or ensure compliant approval process of Global GxP Validation key documents, including Validation Plan, URS, Risk Assessments, Testing Plans, Change Controls that are governing the GxP relevant IT System Validations. Approve and Release for use/production Global GxP relevant IT Systems, including but not limited to eQMS, EDMS, RIMS, LIMS and SAP. STADA Global Governance of GxP CSV Develop strategies to harmonize STADA Global approach on IT validation for GxP systems to ensure lean, efficient and compliant processes. STADA Quality Leader for Global CSV creation, implementation and continuous improvements. Identify any gaps of STADA Global CSV against Pharmaceutical Health Authority regulations, including but not limited to EU GMP Annex 11 and Data Integrity. Lead required enhancement initiatives to ensure compliance. STADA Global Quality CSV Expert and Champion Global Quality CSV expert during Health Authority Inspection, including all STADA operational sites and commercial affiliates. Quality Expert during customer audits at STADA. Quality Expert in STADAs audits at IT system service providers. Global Quality Expert for STADA GxP IT Validation Project Managers, System Owners, Business Owners, Process Owners and Key Users. Global Quality Expert to STADA internal and external clients on any GxP CSV related enhancement initiative and resolution of identified issues, including Data Integrity. Provide training to internal STADA customers related to GxP relevant electronic systems. Preferred candidate profile: Minimum 5+ years of experience in Pharmaceutical Quality IT role. Strong knowledge on GxP and Pharmaceutical Health Authority requirements on Data Integrity, electronic and automated systems, including EU GMP Annex 11. Strong experience in GAMP principals or similar. Experience in latest IT developments, including Cloud solutions Proven experience in leadership and in execution of GxP relevant IT systems. Proven experience in providing training on electronic systems and relevant Quality regulations. Experience in Global electronic and automated systems, preferable with SAP, EDMS, LIMS. Experience with matrix organizations and either in European or global position Fluent English Ability to work directly with Global Quality Leadership members including Global Senior Vice President, other Global and Cluster Heads, Global Project leads, Subject Matter Experts and project team members. Proactive, self-driven, highly motivated, takes responsibility seriously, cooperative, able to work under pressure Good communicator, excellent soft skills Ability to structure complex facts in an understandable fashion Willingness and capability to take decisions Technical understanding of electronic and automated systems Qualification : Graduation / Post Graduation in Pharmacy, Natural sciences, Engineering or equivalent, or long-term experience in the pharmaceutical industry

Role Definition The Laboratory Director, heading the Center of Excellence (COE) in Laboratory Medicine, is responsible for the strategic and operational leadership of all laboratory medicine services, including Clinical Pathology, Hematology, and Biochemistry. The role ensures business enablement, diagnostic accuracy, quality assurance, operational efficiency, clinician engagement, and technical team development. It involves high-level expert consultation, end-to-end laboratory operations management, adherence to regulatory and NABL/ISO standards, and strategic collaboration with clinicians and healthcare providers to strengthen market leadership. Role Deliverables Business Enablement – Drive scientific and commercial growth of laboratory medicine services. Diagnostic Accuracy & TAT Adherence – Ensure 100% accurate and clinically correlated reporting within committed turnaround times. Laboratory Operations Management – Oversee Central and Regional Labs for optimal efficiency, cost control, and resource management. Helpdesk Management – Ensure seamless resolution of clinician and branch queries with technical authority. Clinician Engagement & Scientific Consultation – Build scientific credibility and strengthen clinician partnerships. Quality Management & Compliance – Achieve and maintain NABL/ISO compliance with robust internal and external quality programs. People Leadership – Build, mentor, and lead high-performing technical teams with a strong performance and learning culture. Task And Activities Business Enablement: Drive revenue growth through strategic business development initiatives. Collaborate with business teams to enhance partnerships with hospitals, clinics, and healthcare providers. Act as a medical advisor to key clinicians and healthcare institutions. Engage in scientific marketing, RTMs, CMEs, industry events, and expert consultation to expand diagnostic services. Provide high-level consultation to referring physicians and healthcare professionals to enhance patient management. Respond to technical queries, critical value discussions, and interpretation requests from doctors. Collaborate with business development to address technical queries from partner hospitals and doctors. Collaborate with Marketing for CME content, diagnostic bulletins, and clinician awareness programs. Assess the relevance and volume of current test panels; recommend test menu enhancements based on market and medical needs. Diagnostic Accuracy & TAT Adherence Monitor end-to-end sample workflows for Biochemistry, Hematology, Immunology, and Clinical Pathology. Personally validate critical reports and ensure proper clinical correlation before release. Conduct daily delta checks, histogram reviews, and trend analysis for critical parameters. Identify bottlenecks and ensure 99%+ TAT adherence, coordinating with logistics and operations teams Laboratory Operations Management Implement the laboratory policies, procedures, and quality control protocols as aligned with the Medical Directorate. Oversee daily operations of Central and Regional Laboratories, ensuring efficiency, cost-effectiveness, and compliance. Ensure the accuracy of diagnostic tests and reports. Manage the laboratory resources, including equipment, reagents and other supplies. Manage the laboratory’s financials, including budgeting and cost control. Monitor financial performance indicators and implement corrective actions as needed Quality Management And Compliance Conduct daily quality management practices across Central and Regional Laboratories to meet regulatory requirements. Ensure daily internal QC, EQAS, and LIMS-based control validations are completed and signed off. Manage the Internal audits and participate in external quality assurance programs to ensure compliance. Monitor delta checks, critical value communication, and compliance with QC protocols Implement corrective and preventive actions (CAPA) based on audit findings and quality assessments. Ensure SOPs, checklists, and dashboards are updated on real time basis. Coordinate with the QC Team to monitor and enhance quality control measures. Report quality indicators trends in monthly meetings and track improvements Helpdesk Management Lead the Laboratory Helpdesk team and serve as the primary point of contact for resolving technical queries from branches and clinicians. Ensure seamless communication and issue resolution within defined SLAs. Manage escalations related to test results, patient concerns, and clinician inquiries. Develop and implement protocols to handle service-related complaints effectively. People Leadership Recruit, train, and supervise technical teams. Set an individual role clarity, roster with each team member aligned with the laboratory objectives. Conduct daily huddles with the team to discuss ongoing activities and address any issues. Hold weekly meetings with the team to discuss operational performance indicators and lead measures. Conduct monthly 1:1 meetings with direct repartees to review progress on KPIs and plan the way ahead. Document and share feedback with each team member. Assess individual ASK (Attitude, Skills, Knowledge) on a quarterly basis and manage the learning of the team in collaboration with the HR team to enhance skills and drive career paths. Monthly recognize and reward high performance and initiate improvement plans where necessary. Achieve the People Score of 90. Success Metrics 100% achievement of strategic goals (Revenue & Profitability) 100% accuracy rate in diagnostic tests and reports. 100% timely delivery of diagnostic results within established turnaround times 90% achievement of Quality indicators Adhere to a budget with no more than 2% variance. Customer feedback score of 4.8 or higher. Monthly RTM/ CME/ Clinician engagement activity as per calendar 100% compliance in NABL audits, IQC, EQAS Requirements :: D/DNB in Pathology, with additional training/fellowship in Hematopathology or Laboratory Medicine preferred. 12–15 years of post-MD experience, including 5+ years in leadership of multi-specialty diagnostic labs with NABL/ISO audit exposure. Proficiency in Clinical Pathology, Hematology, Biochemistry, LIMS, quality protocols (IQC/EQAS), and advanced diagnostic technologies. Strong clinician engagement, team mentoring, strategic decision-making, and business-aligned diagnostic leadership.

Job Description Analyst with having the knowledge of Instrument HPLC, UV, FTIR, GC ,Polarimeter , KF, Auto titrator e.t.c. Responsible for sampling, testing and release of Raw material, packing material and miscellaneous material samples and maintain reserve sample as per SOP. Responsible for review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Analysis related to qualification of Instrument/Equipment and Standards Qualification of Standards and Instruments Knowledge and Skill on Sophisticated instruments like UV, HPLC, GC, UPLC, FTIR, Polarimeter and KFtitrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Responsible to perform activities with respective TNI . To ensure the timeline for initiation and completion of testing. Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department Skills And Proficiency Analytical Instrumentation Handling – Expert Particulate Matter Testing – Practitioner Good Laboratory Practices (GLP) & Documentation Accuracy – Practitioner Data Integrity & Documentation – Practitioner Regulatory Compliance – Practitioner SOP Preparation & Revision – Practitioner Analytical testing expertise and evaluation skills – Expert Handling of Analytical Instruments and Interpretation of Resulting Data – Practitioner Laboratory Instrument qualification, Calibration & Maintenance – Practitioner Quality Control & Compliance – Practitioner LIMS Operation & Data Management – Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) – Beginner CAPA, Deviation, and Change Control Management – Beginner Qualifications Qualification : Bachelor or Master's degree in science Experience: Minimum 4 to 6 years of relevant experience in QCC Department Note: Candidate who want to apply for internal job posting must have completed at least 2 years in his current job role.

Job Description Analyst with having the knowledge of Instrument HPLC, UV, FTIR, GC ,Polarimeter , KF, Autotitratior e.t.c. Responsible for sampling, testing and release of Raw material, packing material and miscellaneous material samples and maintain reserve sample as per SOP. Responsible for review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Skills And Proficiency Analytical Instrumentation Handling – Expert Particulate Matter Testing – Practitioner Good Laboratory Practices (GLP) & Documentation Accuracy – Practitioner Data Integrity & Documentation – Practitioner Regulatory Compliance – Practitioner SOP Preparation & Revision – Practitioner Analytical testing expertise and evaluation skills – Expert Handling of Analytical Instruments and Interpretation of Resulting Data – Practitioner Laboratory Instrument qualification, Calibration & Maintenance – Practitioner Quality Control & Compliance – Practitioner LIMS Operation & Data Management – Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) – Beginner CAPA, Deviation, and Change Control Management – Beginner Qualifications Qualification : Bachelor or Master's degree in science Experience: Minimum 4 to 6 years of relevant experience in QCC Department Note: Candidate who want to apply for internal job posting must have completed atleast 2 years in his current job role.

Job Description Analyst with having the knowledge of Instrument HPLC, UV, FTIR, GC, Polarimeter , KF, Auto titrator e.t.c. Responsible for QCC-QMS Section regarding the test procedure, OOS, OOAL, Deviation, Change Control Note, Incident, Investigation Report Preparation e.t.c. Responsible for review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Responsible for QCC-QMS Section regarding the test procedure, OOS, OOAL, Deviation, Change Control Note, Incident , Investigation Report Preparation e.t.c. Skills And Proficiency Analytical Instrumentation Handling – Practitioner Good Laboratory Practices (GLP) & Documentation Accuracy – Practitioner Data Integrity & Documentation – Practitioner Regulatory Compliance – Practitioner SOP Preparation & Revision – Practitioner Handling of Analytical Instruments and Interpretation of Resulting Data – Practitioner Quality Control & Compliance – Practitioner LIMS Operation & Data Management – Practitioner QMS Documentation (OOS, OOT, Deviation & Incident) – Beginner CAPA, Deviation, and Change Control Management – Beginner Qualifications Experience: Minimum 1 to 4 years of relevant experience in QCC Department Note: Candidate who want to apply for internal job posting must have completed atleast 2 years in his current jobrole.

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for monitoring, auditing and assuring the quality of operational aspects of the Facility according to established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements with support of auditors & other senior members. Job Responsibilities Ensures that assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable. Performs audits (both project and non-project related) to assure the compliance to GCP/ GLP, SOPs, regulatory requirements of the following departments wherever applicable; Bio analytical Operations, Clinical Operations Department, Pharmacokinetic Unit, Quality Assurance Unit, and Other general divisional operations. Conducts in process surveillance (both project and non-project related) to assure ongoing compliance of the Bio analytical Operations/Clinical Operations/others Department as applicable. Prepares QA audit reports for all the above audits/surveillances performed. Conducts appropriate follow-up and take to completion any unresolved issues as a result of audit findings. Performs audit / review of software validation packages and IQ/OQ documents for systems used within the facility. Assists in the formal training of new and existing QA staff members to both QA and facility audit and procedures. Revise, implements, and maintains records of standards Operating procedures and additional relevant documents for the facility. Assists in Internal Audits whenever required. Reports to QA Management with respect to the operational status and disposition of all matters relating to the operations in the QA unit. Performs all work in accordance with all established regulatory and compliance and safety requirements. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education Minimum Bachelor Degree holder in Science or Pharmacy. Knowledge, Skills and Abilities Knowledgle on current Guidelines like ICH Guidlines ,GCP and GLP for BA/BE studies Technical skills on LIMS, EP and Analyst software. Ability to perform audits in accordance to GDP, GLP and GCP and other requlatory requirements. Experience Minimum 2-4 years Experience in Regulated Industry. At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.