150 Gxp Jobs - Page 2

Develop, implement & maintain a robust Quality Management System (QMS) in compliance with applicable regulations (GLP, GCP, GXP, ICH guidelines) Create, review, and manage SOPs, work instructions, protocols, reports & documentation across departments Required Candidate profile 4+ years of experience in QA/QC within the pharmaceutical, biotech or drug discovery industry. Quality control certifications are preferred In depth understanding of QA/QC procedures & legal standards

You will be responsible for the site Master Data processes to ensure accurate and timely creation and maintenance of master data in the ERP System, aligning with local and global requirements. As the Material Planner, your role involves driving the tactical purchasing process for all materials to ensure materials availability and execution plan feasibility in accordance with Site inventory policy. Your primary responsibilities will include focusing on accurate and timely preparation and maintenance of master data in the SAP ERP system, aligning with Supply chain operational activities in compliance with GxP & Regulatory requirements, internal regulations, Good Practices, and business objectives. You will be tasked with processing master Data tickets assigned as per relevant SOPs, business matrix, SLA time lines & KPIs, facilitating the setup and maintenance of Global & Local Master Data, and developing functional understanding in Supply Chain, Data Quality, and other domains. Key Role Requirements: - Minimum 6 years of experience in Master Data Operations in Supply chain Management preferred - User experience of Change Control system (e.g. SAP) and Pharmaceutical Industry experience advantageous - Understanding of working in a GxP environment and adherence to compliance policies - Proactive planning, change management anticipation, and meticulous implementation of team goals and metrics - Accountability & ownership of work with good data quality, participation in mandatory trainings, and proactive action for improvements - Initiation and Supply continuous improvement projects for operational excellence and quality enhancement - Compliance with GMP, regulatory requirements, HSE, and hands-on experience in Supply chain management and SAP ERP systems Desirable qualifications include a Graduate/Postgraduate degree in Pharmacy/Life Science/Engineering/Commerce/Economics with excellent spoken and written English skills. Novartis is committed to diversity and inclusion, aiming to build an outstanding work environment and diverse teams. If you are passionate about making a difference in patients" lives and thrive in a collaborative environment, join our Novartis Network to explore career opportunities and benefits aimed at personal and professional growth.,

Novo Nordisk Global Business Services (GBS) India Department Centralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Senior Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. About the department Bangalore Global Development since its inception, has transitioned from a small start-up to one of the largest units in Global Business Services, Bangalore (GBS) and a key contributor to Novo Nordisk clinical development portfolio. The Centralised Monitoring Unit (CMU) was established in GBS in 2016 to support the Risk Based Monitoring of clinical trials conducted by Novo Nordisk in line with health authority requirements. The unit is the single and only entity across the globe responsible for performance of centralised medical monitoring for all clinical trials involving medical review of patient data that includes medical monitoring and lab surveillance and generation of visualisations and reports identifying outliers and trends from various data sources. The Position As a Senior Functional Programmer, the role involves generating standard and customized trial monitoring reports to support Risk-Based Quality Monitoring (RBQM) across clinical trial portfolios, using tools like SQL, SAS, Power BI, and Python. Responsibilities include understanding stakeholder needs, programming data-driven reports from multiple clinical systems, and ensuring high-quality deliverables through rigorous quality checks. The role also includes preparing documentation, supporting process improvements, and contributing to training initiatives. Responsible to generate standard and custom trial monitoring reports using languages like SQL, SAS, Python in different BI tools (Qlik Sense, Power BI, SAS JMP Clinical, Clue Point, eClincal etc.) ensuring alignment with stakeholder needs and RBQM requirements. Responsible to prepare, maintain, and peer-review report-related documentation; develop and perform quality checks to ensure accuracy and compliance. Conduct and chair trial monitoring meetings, gather requirements, train stakeholders on report usage, track requests, and manage expectations and timelines. Train and mentor new team members, support onboarding processes, and assist in developing training materials based on project needs. Ensure contributing to process enhancements, share best practices, and support the manager in resource allocation and project timeline planning. Qualifications A Masters or Bachelors degree in Life Sciences, Computer Science, Information Technology, Clinical Information Management, or a related field. Equivalent qualifications or relevant professional certifications will also be considered. 4"“6 years of experience in the pharmaceutical or life sciences industry, with a minimum of 4 years in clinical data management systems, bioinformatics, or as a Clinical Research Associate. Strong technical proficiency in computer systems and IT, particularly as they apply to clinical data handling and process optimization. In-depth understanding of GxP principles, as well as international guidelines and regulations related to drug development. Knowledge of computer system validation practices is essential. Proven experience in project management, team supervision, and mentoring, with the ability to lead cross-functional and cross-regional collaborations effectively. Strong interpersonal and presentation skills, with the ability to communicate complex technical and clinical concepts to both technical and non-technical stakeholders. Solid understanding of the drug development lifecycle, along with working knowledge of basic medical and clinical terminology. Advanced skills in any of the programming languages such as SAS, VBScript, SQL, PL/SQL, Power BI, or Python. Experience with additional tools like JSL, R-Shiny, or Natural Language Processing (NLP) is a strong plus.

Novo Nordisk Global Business Services (GBS) India Department Centralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. About the department Bangalore Global Development since its inception, has transitioned from a small start-up to one of the largest units in Global Business Services, Bangalore (GBS) and a key contributor to Novo Nordisk clinical development portfolio. The Centralised Monitoring Unit (CMU) was established in GBS in 2016 to support the Risk Based Monitoring of clinical trials conducted by Novo Nordisk in line with health authority requirements. The unit is the single and only entity across the globe responsible for performance of centralised medical monitoring for all clinical trials involving medical review of patient data that includes medical monitoring and lab surveillance and generation of visualisations and reports identifying outliers and trends from various data sources. The Position As a Functional Programmer, the role involves generating standard and customized trial monitoring reports to support Risk-Based Quality Monitoring (RBQM) across clinical trial portfolios, using tools like SQL, SAS, Power BI, and Python. Responsibilities include understanding stakeholder needs, programming data-driven reports from multiple clinical systems, and ensuring high-quality deliverables through rigorous quality checks. The role also includes preparing documentation, supporting process improvements, and contributing to training initiatives. Responsible to generate standard and custom trial monitoring reports using languages like SQL, SAS, Python in different BI tools (Qlik Sense, Power BI, SAS JMP Clinical, Clue Point, eClincal etc.) ensuring alignment with stakeholder needs and RBQM requirements. Responsible to prepare, maintain, and peer-review report-related documentation; develop and perform quality checks to ensure accuracy and compliance. Conduct and chair trial monitoring meetings, gather requirements, train stakeholders on report usage, track requests, and manage expectations and timelines. Train and mentor new team members, support onboarding processes, and assist in developing training materials based on project needs. Ensure contributing to process enhancements, share best practices, and support the manager in resource allocation and project timeline planning. Qualifications A Masters or Bachelors degree in Life Sciences, Computer Science, Information Technology, Clinical Information Management, or a related field. Equivalent qualifications or relevant professional certifications will also be considered. Above 3 years of experience in the pharmaceutical or life sciences industry, with a minimum of 2 years in clinical data management systems, bioinformatics, or as a Clinical Research Associate. Strong technical proficiency in computer systems and IT, particularly as they apply to clinical data handling and process optimization. In-depth understanding of GxP principles, as well as international guidelines and regulations related to drug development. Knowledge of computer system validation practices is essential. Proven experience in project management, team supervision, and mentoring, with the ability to lead cross-functional and cross-regional collaborations effectively. Strong interpersonal and presentation skills, with the ability to communicate complex technical and clinical concepts to both technical and non-technical stakeholders. Solid understanding of the drug development lifecycle, along with working knowledge of basic medical and clinical terminology. Advanced skills in any of the programming languages such as SAS, VBScript, SQL, PL/SQL, Power BI, or Python. Experience with additional tools like JSL, R-Shiny, or Natural Language Processing (NLP) is a strong plus.

Job Title: CSV Engineer Location: Bangalore Experience: 2-4 years Industry: Pharmaceutical / Biotechnology / Lifesciences About the Role: We are looking for a CSV (Computer System Validation) Engineer with hands-on experience in the pharmaceutical, biotechnology, or life sciences sectors. You will be responsible for ensuring that systems are validated in compliance with regulatory requirements and internal quality standards. Key Responsibilities: Perform validation activities for GxP computerized systems (planning, risk assessment, URS, IQ, OQ, PQ, summary reports) Prepare and review validation documentation in line with 21 CFR Part 11, EU Annex 11, and other regulatory guidelines Conduct impact assessments and periodic reviews for existing validated systems Support audits and inspections by presenting CSV documentation and processes Collaborate with QA, IT, and business users to ensure validation deliverables are met within timelines Guide project teams on validation requirements and risk-based approaches Ensure data integrity compliance across systems and processes Key Requirements: Bachelors or Masters degree in Lifesciences, Pharmacy, Biotechnology, or related field 2-4 years of hands-on experience in computer system validation within pharmaceutical, biotech, or life sciences industries Strong knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and data integrity requirements Experience with validation of ERP, LIMS, QMS, or other laboratory/manufacturing systems preferred Excellent documentation and communication skills Ability to work independently and in cross-functional teams

Performing audits of all Dr. Reddy’s Laboratories manufacturing, packing, testing, development centers and distribution warehouses as per the audit schedule. Primarily performing internal audits of CTO, FTO and R&D Sites. Performing GAP assessment of the new/revised regulatory guidance documents, USFDA warning letters / form 483s to evaluate the current approved documents for compliance / improvements or requirement of new procedures and harmonizing and implementing the best practices across sites. Review of audit responses and tracking the CAPA generated out of internal audits, regulatory audits, customer audits, cross-applicable CAPAs through OCMS, Warning letters & 483 forms gap assessment of all sites for timely and effective implementation. Performing on site verification or review of the documented evidence for compliance of previous audit observations. Preparation and review of harmonized Standard Operating Procedures and Guidance documents which shall be implemented at Global, FTOs, CTOs business units and related supporting functions. Assessing the impact on the procedures during implementation of changes in IT applications. Overview harmonization of CSV/IT compliance practices across Dr Reddy’s sites. Ensuring timely assessment and implementation of pharmacopeia and regulatory guidance updates w.r.t. CSV/IT compliance procedures across Dr Reddy’s sites. Ensuring review and implementation of simplification procedure for different CSV/IT compliance procedures across Dr Reddy’s sites to reduce redundancy. Tracking and revision of SOPs identified during SuCCEED drive and Re-Imagine QMS. Conducting training sessions for the approved documents before implementation of the procedure. Preparation of questionnaire for SOP in order to evaluate the effectiveness of training imparted. Initiation and review of quality notifications raised for revision, preparation of documents as per identified requirements. Timely communication to stakeholders about revision/implementation of SOPs. Providing data for monthly report. Providing support to sites during regulatory audits for review of systems / documents. Any work assigned by the Lead and Head of the Department Qualification M.Sc (Chemistry) with 15+ years of Pharma experience in IT/CSV quality Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com

Position Summary: We are seeking a highly experienced and driven Business Analyst to lead and manage Product digital and IT initiatives within the pharmaceutical/life sciences sector. The ideal candidate will have strong experience in Business analysis, stakeholder engagement, and driving execution across multiple workstreams, while ensuring compliance with regulatory and quality standards. ______________ Key Responsibilities: Lead end-to-end product management for IT/technology initiatives in the pharma/life sciences domain, ensuring requirement gathering , gap analysis , process flows modelling documentation practices and technical document writing. Experienced in data analysis (SQL, ETL etc), automated testing experience (UAT experience), understanding of Machine Learning and AI Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Commercial teams. Define product scope, objectives, backlog refinement. Manage vendor coordination, software implementation, system integration, and infrastructure deployments. Ensure alignment of projects with industry regulations such as GxP, CFR Part 11, HIPAA, GDPR, etc. Experience in change management, training, and adoption strategies. Ensure adherence to internal project governance, compliance, and validation procedures. Proficient in Jira, Confluence, ALM, Vera, Veeva platforms, Lucidchart, Microsoft Tools, PowerBI. Soft Skills: Problem solver, critical thinker, detail oriented and big picture thinker, inquisitive, ability to communicate technology to the business/decode solutions, process optimization. ______________ Required Qualifications: 5 to 8 years of total experience in IT/Technology Business analysis, with at least 4 years in the Pharma/Life Sciences domain. Strong understanding of regulatory environments and compliance standards (FDA, GxP, CSV, etc.). Hands-on experience with Agile, Scrum, or Hybrid delivery methodologies. Ability to manage cross-functional teams and third-party vendors. Excellent communication, stakeholder management, and leadership skills. Relevant BA certification is a plus ______________ Must Have: Analysis Experience with data platforms, analytics in pharma, or AI/ML initiatives in life sciences. Exposure to cloud migrations, enterprise platforms like SAP, Veeva, Oracle Health Sciences, etc. Understanding of pharma manufacturing processes, quality control, or clinical development lifecycle. ______________ Education: Bachelors/Master’s degree in Engineering, Information Technology, Life Sciences, or related field.

OVERALL OBJECTIVES: As a senior member of the team, you will join a challenging and unique large-scale Transformation Program with high impact and visibility. Primary focus is the assessment, planning and implementation of new or improved IT Services as part of the project engineering team. Senior Reliability Engineer (SRE) is primarily responsible for the engineering, configuration, installation, and maintenance of; Windows physical and virtual servers, Active Directory, Azure cloud and on-prem environments based on Hyper-V/VMWare, storage, backups, and disaster recovery planning. We rely on our engineers to empower our users with high availability, excellent performance levels and key service. Ideally, we are seeking an experienced engineer to deliver insights and guidance as we design, build, and operate a state-of-the-art multi-cloud greenfield infrastructure. Of most interest to us is someone who brings ideas and solutions, a lateral thinker, demonstrates a unique and informed viewpoint, and enjoys collaborating with a cross-functional team to develop real-world IT service. Management Infrastructure and Identity services, Server Virtualization, Operating Systems, Multi-Cloud infrastructure Primary Focus Build, configure and operate Microsoft Windows Server Environment Manage Active Directory Entra ID Hyper-VManage server and storage resources Develop and implement agile and scalable infrastructure solutions, with advanced monitoring and alerting, while establishing best practice tools, frameworks, and processes Assists with advanced troubleshooting (proficient in all levels and phases of systems support) Identify, diagnose, and resolve connection, reliability, or performance issues Contact vendor technical support for Priority 1 incidents and requests Develop scripts (mainly Powershell) to deliver automation and innovation initiatives, ability to drive automation initiatives independent of automation tools. Validate system upgrades and patches when required Additional Focus Areas Team members are expected to grow their expertise in other systems engineer areas to provide support for the entire IT infrastructure landscape through formal training, job shadowing, service transition and documentation Evaluate, recommend, manage, and operate compute and storage resources on Cloud Support of non-Windows operating systems Core IT Infrastructure Technology / Operations Duties Partner with other infrastructure Team Members to learn, develop and enhance the skills needed to support software-based infrastructure Ensure that IT Services are delivered effectively to business customers. This includes the execution of SOPs (Standard Operating Procedures), management of IT Incidents/Problems and IT Changes as per well-defined ITIL processes, as implemented in the ITSM system. Contribute to the reference documents to establish consistency and shared knowledge of Operations best practices and delivery methods. Deliver quality documentation allowing smooth day-to-day operations Identify opportunities to innovate, extend and enhance service delivery wherever possible Participate in disaster recovery plans and practicing recovery operations Consult with senior peers to learn through experience Partner with key vendors to maintain an understanding of modern technology and leading practices Cooperate closely with other Zone / Regional / Group IT Infra resources Provide after-hours on-call support (rotation) and participate with solution implementation (upgrades, new releases, ) and deployment activities after hours as needed Additional / Certifications Microsoft Certifications like Former MCSE, MCST are required Certifications in any of the following or similar technologies are a plus: Azure, VMWare ITIL Foundation certification is a plus Work Experience Minimum 7-10 years of experience on Windows 2016-2019 Server environments, Microsoft Active Directory Minimum 2-4 years of experience in managing public cloud-based resources in Microsoft Azure Experience on Hyper-V/VMware virtualization environments Experience or knowledge on Bare Metal Servers (ILO, IDRAC, Firmware management) Experience or knowledge on Storage Concepts Experience with or knowledge on backup tools like CommVault Competencies & Skills: Technical Skills Experience in IT Infrastructure and Operations administration, engineering, architecture (enterprise scale), including demonstrated working experience with: Windows OS system administration Microsoft Active Directory Entra ID Administration Microsoft PKI Services Virtualization technologies like Hyper-V/VMware Infrastructure Services (DNS, DHCP, NPS, etc.) Automation and self-service solutions Scripting languages such as PowerShell, Bash, etc A solid understanding of Windows Systems Administration, Active Directory virtual machines, and networking fundamentals. Knowledge on Azure fundamentals (IAM, network, security, etc.), plus working experience with (provisioning of / migration to / support of) Azure Server & Storage resources Hands-on experience creating resource groups, virtual networks, load balancer, virtual machine, attaching storage disks, amongst other Cloud operations Experience supporting IaaS, PaaS, and SaaS based solutions Experience with or knowledge of backup & disaster recovery preparedness, monitoring, testing, and activation. Experience in monitoring, alerting and analytics, proactive maintenance, root cause analysis, and troubleshooting. Working experience in observability tools Exposure with IaC: Terraform, Ansible, etc. is a plus Understanding of Docker, Kubernetes and Jenkins, etc. Other / Soft skills Passion for technology and staying current with emerging security trends Accustomed to working in a fast-paced environment with a career track-record of engineering, developing, deploying, and maintaining business critical systems Able to troubleshoot complex problems, and translate technical issues into understandable business language for end users Compliance with standards for quality, performance, or productivity Able to prioritize, drive results and provide clear and documented status updates/metrics to management. Translate business requirements into scalable infrastructure designs, cost models, and forecasts. Excellent writing and communication skills (fluent spoken and written English); excellent interpersonal skills and able to interact and work efficiently with people at all levels in an organization (internal employees, contractors, managers, third parties, etc.). Apply curiosity and technological intellect to analyze emerging concepts and make necessary recommendations to achieve transformational results in Deployments, Application & Infrastructure Support, and Automation Setup and Implementation. Knowledge of laboratory (regulated/controlled environment) operations and processes is a plus Familiarity with relevant regulatory requirements (GxP, HIPAA, GDPR, ) is a plus Qualifications Bachelor's degree in computer science / comparable fields or equivalent working experience.

We are looking for a Computer System Validation (CSV) Engineer with specialization in SAP HANA/S/4HANA validation to join a prestigious MNC Pharma company at their corporate headquarters in Mumbai. As a CSV Engineer, your main responsibilities will include developing and overseeing CSV deliverables such as VP, URS, FRA, IQ/OQ/PQ, etc. It is essential to ensure adherence to regulatory standards like 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborating with diverse teams including QA, IT, and BPOs will be a key aspect of your role. Additionally, managing SAP system upgrades, patches, and audits will be part of your day-to-day tasks. The ideal candidate should hold a Bachelor's degree in Computer Science, Engineering, or Life Sciences and possess a minimum of 3 years of experience in CSV within regulated industries. Proficiency in GxP, ALCOA+, and data integrity standards is required. Candidates with SAP HANA Certification and experience in audit trails, security roles, EDMS/QMS are preferred for this role. This is a full-time position located in Mumbai. To apply, please send your CV to ankur.tiwari@ics-india.co.in or contact +91 9109188512. Join us now and contribute to the global pharmaceutical innovation journey.,

Trackwise Consultant Experience: 5 to 8 Years Location:- Bangalore/Pune/hyderabad Notice period : Immediate to 15days Job Description Knowledge of Trackwise is a must Should have indepth knowledge of handling Quality management in TrackWise Should have a strong understanding of Trackwise Business processes such as Change Management System IncidentDeviation Investigation CAPA implementation etc Should have a deep understanding of the individual workflowsapprovals in each Trackwise Module Experienced in generating various types of queries in TrackWise requirements Well versed knowledge of Quality Risk assessment through TrackWise Application Should have managed QMS implementation projects including configuration migrations data migration multisite rollouts data archival etc Should have adequate knowledge in performing gap assessments from an end user perspective Need to ensure quality assurance procedures are followed and in accordance with Customers methodology and standards Minimum 5 years of experience in a Pharmaceutical Life Sciences setting is preferred Experience with industry standard and best practices regarding quality quality assurance and quality control principles and techniques eg 21 CFR Part 11 GAMP 5 Versed in health authority regulations such as FDA 21 CFR MHRA Annex 11 Subject Matter Expert in GxP GDP GLP GMP and Data Integrity Mandatory Skills : Architecture Principle Design, Software Engineering and Design Architecture, Trackwise

1.Responsible for Sample Management Activities like Sample collection, Handling, Labeling, Tracking, Chain of custody documentation and Sample Disposal 2.Responsible for arranging the samples to be sent to the vendor for the required external testing and receiving the appropriate reports 3.Responsible for following GLP/GDP practices and Compliance with respect to sample management. 4.Responsible for reagents / chemicals / standards / consumable / utilities receiving, labelling, proper maintenance, consumption records listing of procurements requirements.

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Requirements Strong knowledge of Kneat CSV principles and practices. Experience working with large datasets and complex data processing systems. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Familiarity with industry-standard data integration tools and technologies.

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clients QMS and quality training requirements. Responsible for ensuring that the work conducted by the Facilities team, and its subcontractors is in full compliance with contractual requirements, clients SOPs, GxP, FDA and other regulations. Able to perform/support internal JLL compliance audits and prepare SOPs, and training materials for use by the Life Sciences facilities team in the performance of their work. Guide Life Sciences facilities team in closing recommendations from clients audit. Expected to interface with the clients quality personnel to ensure that all of the clients SOPs are followed, work performed by the LS facilities team is properly documented for traceability in the framework of GDP. Sustain quality assurance support and develop a Quality Engineering Maintenance program for a controlled-environment manufacturing and laboratory facility as it relates to the facilities maintenance of this plant. Conduct investigations and drive accountability for all quality events. Lead programs to create value for client to ensure program deliveries meet or exceed expectations. Facilitate quality-relevance investigation via structured Root Cause Analysis. As part of career development, lead Life Sciences accounts as an IFM leader.Reporting Manage and report on critical & key performance measurements. Develop and submit periodic site status reports related to the Quality Program. People Management Effectively lead and guide a Life Sciences Quality team by clearly communicating expectations, accountabilities and providing performance feedback for continuous improvement. Ensure Life Sciences Operations team members complete relevant quality and compliance training. Coach new Life Sciences team members on quality and compliance for their adaptation into specific Life Sciences accounts. Mentor, develop and train peer and direct report team members. Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.Others Any other quality-relevant duties and tasks assigned. Knowledge, Skills & Abilities. MINIMUM REQUIRED / PREFERRED - Education/training Bachelor degree preferred Degree in science, technical or relevant discipline Sound fundamental knowledge in process utilities. 6+ Years of relevant experience preferred with minimum 4+ years in Quality and Compliance discipline in GxP manufacturing or laboratory environment. Six-Sigma and Root Cause Analysis training is essential. Skills and knowledge Background in technical documentation Work independently and within a team. Strong mindset of compliance and client-focus. Communicate effectively with technical, quality assurance and other personnel. Proficient in Word, Excel and other Microsoft Office Suite programs Ability to investigate, recognize and diagnose trends and patterns. Solid understanding of cGMPs as they relate to the performance of maintenance and repairs to facilities, utilities and equipment utilized for the manufacturing plants and laboratories for drug products. Experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity. Support investigations and corrective action plans for appropriate discrepancies. Investigation of compliance issues as required, collaborating with relevant Compliance Partner(s) Understanding of FDA regulations including 210 CFR part 210 and 211. Strong commitment to quality assurance, and a willingness to help develop a quality first culture on the site. Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems English communication is essential Other abilities Good oral and written communication skills including the ability to communicate to all levels of management and willing to interface with a diverse customer base including technical and non-technical personnel.Physical work requirements and work conditions Familiar with process utilities and GxP environment.

CSV L1/L2 Support Validating, Reviewing and updating validation documentation Hands on exp in CSV principles and GxP compliance. Experience in validation practices with hands on exp in 21 CFR Part 11/ EU Annex 11 /GAMP 5 Guidelines /GxP Standards

Greetings from HCL! Currently Hiring for "Validation" JD: Computer System Validation (CSV) Good Documentation Practices (GDP) Regulatory Compliance (GxP, FDA 21 CFR Part 11, EU Annex 11) Risk Assessment & Management & SDLC Experience - 5-14 years Location - Bangalore / Chennai / Noida / Pune / Hyderabad Notice period - Immediate to 30 days Only CTC - Can be discussed Interested candidate please share below details along with update resume Name- contact Number- Email ID- Total Experience- Relevant Experience- Current company- Preferred location- Notice Period- Current CTC- Expected CTC- Interested candidate please drop mail to "kushmathattanda.baby@hcltech.com" Regards, Kushma kushmathattanda.baby@hcltech.com

Minimum 10 - 12 years of experience in handling complex large transformation projects Experience in Client Relationship Management – key client stakeholders, understanding their requirements and Outsourcing ability to meet them Experience of leading large teams located across multiple cities in India and across the world. Experience of Driving Digital Transformation across a portfolio of accounts Demonstrates a breadth and depth of operational service delivery management expertise. Preferred: Ability to create technical designs based on functional designs, including, mockups, process and data flow diagrams, etc Ability to gather critical information from meetings with various stakeholders and produce useful reports. Ability to conduct market research for product development Knowledge of cloud platforms (Fundamentals of GCP/AWS/Azure) GDPR, HIPAA/GXP compliance, ERP and SAP application Role Lead the delivery of multi-functional, large-scale Cloud transformation projects Conduct a thorough review of all components in the Project/Program Plan: scope, deliverables, time frame, and cost Stakeholder management ( Internal and external ) Manage the risks, issues, scope changes, unplanned events and other actions of the project and regularly track them to meet the expected outcomes and timelines, building mitigation plans as the program evolves. Work closely with Developers, BA, Quality, Engineering, and cross-functional team to resolve issues that arise during design, implementation and in post-production. Work with external and internal partners on integration and product expansion opportunities.

As a Senior Principal at Infosys Consulting dedicated to serving Life Sciences firms globally, you will play a crucial role in managing transformations from strategy setting to execution, ensuring the delivery of realized business value. We are looking for individuals with exceptional communication skills, intellectual curiosity, and a strong passion for ethics and compliance management, particularly in the field of Risk & Compliance within Life Sciences. Your responsibilities will include conducting comprehensive risk assessments of AI applications, ensuring compliance with relevant regulations and standards, developing risk assurance frameworks specific to AI technologies in life sciences, collaborating with cross-functional teams to identify and mitigate AI-related risks, and establishing metrics to track AI risk factors. Additionally, you will lead the design and implementation of control integration systems, ensure SoX compliance for life sciences clients, and provide guidance on regulatory requirements and best practices. To excel in this role, you should have a minimum of 15 years of overall experience, with at least 2 years of top-tier consulting experience post MBA, specifically in programs/projects with Life Sciences/Healthcare clients. You should possess a strong regulatory background in areas such as 21 CFR part 11, Data Privacy, Data Integrity, Information Security, GxP, and SOX IT knowledge. Your ability to handle multiple large projects, engage with senior business and technology leaders, and stay abreast of market and regulatory trends will be crucial. At Infosys Consulting, you will be responsible for delivering business results to global pharmaceutical, medical devices, and pharmaceutical distributors. You will serve as a team member or lead on consulting engagements, execute projects in a global delivery model, contribute to sales pursuits and internal initiatives, analyze complex business problems, and drive business process improvement using various consulting tools and methodologies. Your role will also involve collaborating with client teams, creating detailed action plans for organizational change management, and participating in thought leadership events to build deep industry expertise. If you are a self-driven individual with a passion for driving business transformation and ensuring compliance in the Life Sciences sector, we invite you to join our team at Infosys Consulting and make a meaningful impact in the field of Risk & Compliance within Life Sciences.,

We have an exciting opportunity for a Manager IT-MES & L2 project coordinator at our Halol/Baska(Gujarat) location. As a seasoned professional with 7-9 years of experience in the pharmaceutical industry, you will be responsible for overseeing Manufacturing Execution Systems (MES) and L2 integration. Your role as the Site Project coordinator for MES Implementation will involve coordinating all MES-related activities at the Halol / Baska sites. It is essential that you provide dedicated full-time support to the project to ensure smooth execution, alignment with the global MES strategy, and timely delivery of milestones to enhance manufacturing efficiency, compliance, and digital transformation. Collaboration with internal teams including QA, IT, SAP, business users, and L2 integrations, as well as external vendors and infrastructure leads, will be a key aspect of this role. Your responsibilities will encompass stakeholder management, managing project timelines, risks, and dependencies, ensuring infrastructure readiness, facilitating change management, and maintaining compliance with site validation and quality standards. As the single point of contact for MES implementation at the site, you will play a critical role in driving collaboration and successful deployment. It is crucial to ensure adherence to global regulations such as FDA 21 CFR Part 11, EU GMP, GAMP5. Previous experience with Werum (Korber Pharma) for the pharma industry is highly desirable. Your main areas of responsibility will include: - Project Coordination: Leading and coordinating all MES implementation activities at the site to ensure alignment with the global MES strategy. - Stakeholder Management: Serving as the single point of contact for site-level stakeholders, including QA, QA IT, IT, SAP, and business users (Production & Engineering). - Vendor & Partner Collaboration: Working closely with MES vendors, infrastructure teams, and integration partners to ensure smooth execution. - Timeline & Risk Management: Managing project schedules, tracking milestones, identifying risks, and implementing mitigation plans. - Infrastructure & Readiness: Ensuring site infrastructure (network, servers, systems) is ready and validated for MES deployment. - Compliance & Validation: Overseeing adherence to site quality standards, IT validation (CSV), and regulatory requirements. - Communication & Reporting: Maintaining clear and timely communication with the Global Project Manager and other stakeholders; providing regular updates and escalating issues as needed. - Change Management: Facilitating change control processes and supporting user readiness and adoption. To qualify for this role, you should hold a Bachelor's degree in Engineering, Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field. A Master's degree (e.g., MBA, M.Tech, M.Pharm) with specialization in Project Management, Operations Management, Industrial Automation, or Pharmaceutical Technology is preferred. Specific certifications such as PMP for structured project execution and GAMP5 or CSV Training for compliance in regulated environments are advantageous. Ideally, you should have 9 to 10 years of experience managing IT or digital transformation projects, preferably in pharmaceutical manufacturing. Hands-on experience with MES platforms, L2/PLC systems, and SAP integration and Edge Cloud IoT is required. A proven track record in project planning, stakeholder coordination, and cross-functional team leadership is essential. Strong background in GxP compliance, CSV, and validation protocols (IQ/OQ/PQ) is crucial, along with experience working on the shop floor and with QA, IT, and business teams in a regulated environment. Your functional and behavioral skills should include strong project management expertise in IT/digital systems, knowledge of MES platforms, L2/PLC systems, and SAP integration, familiarity with GxP, CSV, and validation protocols, understanding of pharmaceutical manufacturing processes and shop floor operations, proficiency in stakeholder coordination and cross-functional collaboration, strong communication and interpersonal skills, proactive problem-solving and risk management, high attention to detail and compliance mindset, ability to work under pressure and manage multiple priorities, and a team-oriented approach with a focus on collaboration and accountability. Additional skills such as knowledge of data analytics tools, Edge Cloud deployment experience with IoT and IIoT, L2 integration with MES, MES integration with SAP, and understanding of network and databases would be beneficial for this role.,

Experience in CSV, GAMP, GXP, 21CFR, Part11. Experience in Documentation Writing Good Communication skills. NP - Immediate to 15 Days

Job Type: Full-Time Experience Level: 5+ years in MES / Automation domain with strong expertise in Siemens Opcenter EXPH Job Summary: We are seeking a skilled and experienced Siemens Opcenter Execution Pharma (EXPH) Consultant to join our dynamic team. The ideal candidate will have hands-on experience in installation qualification, development, configuration, and upgrades of Opcenter EXPH, as well as a strong background in MES, SCADA(Optional), Automation, and related software systems. Key Responsibilities: Lead and support installation qualification, upgrades, patching, and configuration of Siemens Opcenter EXPH . Perform development and customization tasks including electronic recipe design, simulation, and testing. Work on full lifecycle delivery of MES, SCADA(Optional), and automation projects. Analyze business and recipe requirements and translate them into functional MES configurations and electronic batch records (eBR). Design and implement solutions involving modules like: User Management PI Management, Process, Review Equipment Management Weighing & Dispensing, PI Assembly XSI Console, Material Flow Management Troubleshoot and resolve technical issues across hardware, software, and network layers across MES. Collaborate with cross-functional teams for system integration, validation, and testing. Provide technical expertise on POSTGRE SQL DB , SQL Server Reporting Services (SSRS), VB scripting in MES . Support system access, hardware support, and security compliance. Define and support overall solution architecture (HW, SW, Network). Document configurations, perform impact assessments, and ensure compliance with regulatory standards (GxP, 21 CFR Part 11, etc.). Required Skills & Experience: 5+ years of experience in MES/Automation systems implementation Hands-on experience with Siemens Opcenter Execution Pharma (EXPH) (formerly SIMATIC IT eBR) Strong knowledge of POSTGRE SQL DB, VB scripting, and SSRS,MES system Monitoring Experience in recipe process design and eBR configuration Good understanding of integration between MES, SCADA(Optional), Automation, and Historian systems Experience in patch management, version upgrades, and system validation in MES Strong analytical and problem-solving skills in MES Preferred Qualifications: Bachelors or Master’s degree in Engineering, Computer Science, or related field Familiarity with GAMP 5 guidelines, GxP compliance, and 21 CFR Part 11 Experience with pharmaceutical manufacturing processes and workflows Siemens or MES-related certifications (preferred) Share resume at info@gntpage.com or Whatsapp at 8629031243

Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 23 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control Support Analyst ,Application Admin ,IT Support, GLP Compliance ,Application Support ,SOP ,System Validation

Zoetis, Inc. is the world's largest producer of medicine and vaccinations for pets and livestock. Join the Zoetis Tech & Digital (ZTD) Global ERP organization at Zoetis India Capability Center (ZICC) in Hyderabad, where innovation meets excellence. As part of a leading animal healthcare company, ZICC is dedicated to driving transformative advancements and applying technology to solve complex problems. The mission is to ensure sustainable growth and maintain a competitive edge for Zoetis globally by leveraging exceptional talent in India. As a member of ZICC, you will collaborate with colleagues worldwide, embodying the spirit of One Zoetis. Together, seamless integration and collaboration are fostered to create an environment where your contributions can have a real impact. Join us on the journey to pioneer innovation and drive the future of animal healthcare. The role entails responsibility for SAP Plant Maintenance module, Production Planning, Manufacturing, Lab Information Management System ERP system solutions at Zoetis. It requires strong experience with SAP Quality Management. Responsibilities: - Act as an SAP Solution Architect / Functional Designer - Deliver SAP Solutions aligned with business requirements and best practices - Gather requirements and estimate for SAP Project requests - Analyze to identify potential impacts for project/enhancement requests - Design, configure, and test SAP PP-PM and QM solutions - Integrate QM interfaces with third-party applications - Work with peers and business representatives to determine business process and solution design - Collaborate with other SAP functions to ensure process integration and consistency - Train others for quick onboarding and productivity - Manage colleagues and/or contractors reporting to this position - Provide support for global and regional systems and services - Ensure audit, SOX, and other compliance requirements - Identify and initiate process improvements - Monitor process compliance and performance metrics Position Responsibilities: - Act as a bridge between Business and technical teams - Work closely with stakeholders to deliver robust and compliant SAP Manufacturing solutions - Responsible for meeting KPI targets, continuous improvement, and automation - Serve as a Technical Subject Matter Expert for SAP Manufacturing Plant Maintenance Education and Experience: - Bachelor's degree in engineering, Computer Science, Manufacturing, Supply Chain, or related field. Master's degree preferred - 8+ years of SAP delivery & configuration experience with multiple full life cycle implementations - Functional/Technical proficiency with at least 3 full lifecycle SAP implementations - Experience in pharmaceutical/life science business and knowledge of GxP is a plus - S4/Hana Experience for Manufacturing and Quality Solutions preferred - Ability to work independently and coordinate multiple priorities in a collaborative environment Technical Skills Requirements: - Experience with configuration of SAP S4 HANA, ECC 6.0, MM IM WM - Detailed knowledge of SAP Plant Maintenance, Transactional activities, Maintenance notifications, orders, Preventive Maintenance, Calibration, etc. - Extensive experience in interface with external systems, data transfers, and reporting - Ability to configure master data, work orders, maintenance plans, etc. - Proficient in testing, development, enhancement, UAT, and user training Physical Position Requirements: This role is based in Hyderabad, India, with occasional weekend work and travel requirements based on project demands. Regular hours are from 3:00 AM to 12:00 PM EST. Join Zoetis, a Fortune 500 company, and world leader in animal health, to advance care for animals and humankind. Embrace a culture of inclusion and diversity, where each colleague can thrive and make a positive impact.,

Efficiently monitor all operations which affect the quality. Devise procedures for inspecting and reporting all the persisting quality issues. Assure the consistency and reliability of production with thorough checking procedures and final output. Supervise and guide inspectors, technicians, and all other staff. Report all malfunctions to production executives only to ensure immediate action. Appraise all the requirements of customers and ensuring they are quite satisfied. Facilitate proactive solutions by collecting and analyzing quality data. Keep permanent records of quality reports, statistical reviews, and relevant documentation. Review the current standards and policies. Communicate with external quality assurance officers during on-site inspections. Efficiently ensure that all the legal standards are met with great care. Provide assistance during the recruiting process. Efficiently create reports for tracking progress.Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.

Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provideconstructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop theirprofessional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagementwithin the team Mandatory Skills: SAP FS-CM Functional. Experience: 8-10 Years.

We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applications supporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 2-3 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control.