1756 Gmp Jobs - Page 20

Currently we are hiring Q.A officer for our pharma manufacturing industry. Requirement:- Qualification:- M.Sc./Pharma/Pharma Experience :- Fresher can apply Location:- Panoli (Gujarat) Salary :- As per company norms Benefits:- PF/Bonus

Execute and monitor API production operations as per BMRs, SOPs, and production plans. Handle day-to-day operations of reactors, centrifuges, dryers, and other related equipment. Ensure compliance with cGMP, safety, and environmental guidelines. Required Candidate profile Coordinate with QA/QC, maintenance, and warehouse departments to ensure smooth workflow. Ensure line clearance, raw material availability, Immediate to 30 days preferred

Novo Nordisk Global Business Services (GBS) India Department GCM DP RoW Job Location Hyderabad Are you an expert in aseptic manufacturing with a strong quality mindset and a desire to make a tangible impact on global healthNovo Nordisk is seeking a dedicated Manufacturing Specialist to join our Global Contract Manufacturing Drug Product (GCM DP) team in Hyderabad, India. In this role, you''ll be crucial in ensuring the high-quality production of life-saving insulin and GLP-1 products through our Contract Manufacturing Organizations (CMOs). ! The Position As a Manufacturing Specialist (SME), you''ll be the go-to expert driving Technology Transfer projects for commercial products, ensuring top-tier quality with our Contract Manufacturing Organizations (CMO) partners. Your key responsibilities will include: Lead cross-functional teams, ensuring seamless collaboration between Novo Nordisk as the sending Unit and Contract Manufacturing Organizations (CMOs) partners as the receiving Unit. Act as a mentor and support Contract Manufacturing Organizations (CMOs) to ensure Novo Nordisk products are manufactured to the highest quality standards. Provide training, share best practices, and review and approve validation documents to safeguard compliance. Offer oversight and support during the planning and execution of validation and qualification activities. Define, manage, and deliver on complex projects in collaboration with CMOs, Quality Assurance, and project managers. Drive problem-solving initiatives and provide scientific and technical solutions within tight project timelines. Qualifications Bachelor’s /Master’s degree in engineering. Possess 10+Years experience and relevant 5 years of manufacturing experience, especially in an international, multicultural environment. Expertise in aseptic manufacturing processes is non-negotiable. Capable of communicating naturally and effectively with stakeholders at all levels with adept at finding solutions and motivating stakeholders to achieve ambitious goals. Possessing a strong mindset, a focus on continuous improvement, and keen attention to detail. Demonstrates the ability to work independently with minimal supervision, a strong willingness to learn new skills, and the motivation and flexibility to thrive in a fast-paced, dynamic environment. About the Department GCM DP RoW Projects is dedicated to delivering life-saving insulin and GLP-1 to patients in regions such as Africa, India, the Middle East, and Asia. By partnering with CMOs in these areas, the department plays a pivotal role in improving the quality of life for patients living with diabetes and obesity. With a focus on Market Access initiatives, the team tailors projects to meet the unique requirements of each country, offering exciting growth opportunities. The department thrives on innovation and problem-solving, overcoming challenges and navigating complex regulatory landscapes to deliver insulin and GLP-1 on a global scale. Based in Hyderabad, India, you’ll join a diverse and dynamic team committed to making a difference.

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing. Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR). Conduct in-process checks and ensure batch release activities. Required Candidate profile Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.). Review of analytical documents, stability protocols, validation protocols & reports. Immediate to 30 days preferred

Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and govern if the defined processes are being executed from time to time, including regulatory changes In-depth understanding of KYC and Other Regulatory Guidelines. Providing tailor made solution to Product Operations for specific business requirement. Ideate & suggest Product and Operations with end to end execution of a Process Digital Journey"s new initiatives features etc. Ensuring the Digital Journey controls and logics is in line with defined Process, Regulation and Risk perspective Responsible for the documentation of Business Processes, workflows. Publish MIS and Reports Job Requirement Graduate/Post-Graduate with at least 5 to 6 years of experience in Business Processes In-depth knowledge of Credit Cards business Knowledge of Regulatory requirements and market competition/intelligence will be an added advantage. Excellent communication skills Verbal & Written Good Logical reasoning and data analysis skill Should be able to think proactively for process changes from Business Process Re-engineering perspective Assertive attitude Self-Driven and ability to follow-up promptly Good analytical skills & eye for details

Perform line clearance activities prior to production operations. Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and Batch Filling Records (BFR). Execute in-process QA checks and verifications during manufacturing and packaging. Manage control sample collection, storage, and documentation. Collect in-process, finished product, and customer complaint samples as required. Compile Annual Product Quality Review (APQR) data and perform trend analysis. Participate in process validation, hold time studies, and related quality activities. Coordinate with relevant departments for timely batch release. Conduct routine GMP checks in production, warehouse, and other relevant departments. Coordinate and review vendor management documents and compile vendor assessment reports. Manage document archival as and when required in compliance with applicable procedures. Issue and control formats, Standard Operating Procedures (SOPs), specifications, and batch records. Qualifications: B.Pharma/M.Pharma/M.Sc (Chemistry) Exp.- 5-10yrs

The Deputy Manager - Quality Management System (QMS) is responsible for overseeing and ensuring the effective implementation, maintenance, and improvement of the Quality Management System within the PCC Digwal. The role involves meticulous management of documentation, adherence to regulatory requirements, and proactive involvement in quality-related processes. Key Responsibilities: Key Responsibilities: 1. Manage the ENSUR system for issuance and retrieval of SOPs, specifications, ATRA, worksheets, stability protocols, BMRs, BPRs, BFRs, etc., as per requirements. 2. Ensure adherence to document control procedures, including archival, retention, and destruction of documents as defined in the procedure. 3. Manage master and obsolete copies of SOPs, specifications, ATRs, worksheets, stability protocols, BMRs, BFRs, BPRs, etc. 4. Track SOPs, procedures, specifications, etc., for revision according to their validity period. 5. Responsible for archival management, including archival and retrieval of documents as required. 6. Perform login and review of quality management system documents such as change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 7. Track all quality management system documents till closure, including change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. 8. Generate monthly tracking reports for quality management systems as per defined procedures. 9. Handle product quality complaints (Adverse Events) and medical inquiry reconciliation tracker for the Digwal site, coordinating with Pharmacovigilance team for adverse events as applicable. 10. Review and approve investigation reports, risk assessment reports, and ensure the implementation and effectiveness assessment of CAPAs. 11. Review quality system documents such as protocols, reports, procedures, APOR, trend analysis reports, continual process verification reports, etc., as required. 12. Share documents with the Regulatory Affairs department for filing updates based on change control implementation. 13. Prepare and review customer and external audit compliance reports. 14. Review and approve analytical reports such as batch analysis, standards, stability studies, etc. 15. Perform GMP verification and compliance review. 16. Ensure compliance with Safety, Health, and Environment (SHE) guidelines, rules, and regulations, including the usage of Personal Protective Equipment (PPE) where applicable. Qualifications: Bachelors degree in pharmacy, Chemistry, or related field. Master's degree preferred. 8-12 years of relevant experience in pharmaceutical Quality Assurance/QMS roles( API / API & Formulations ) Strong understanding of regulatory requirements and quality standards in the pharmaceutical industry. Excellent organizational, communication, and problem-solving skills. Ability to work effectively in a team and independently, with attention to detail and accuracy Skills: Proficiency in handling documentation and data management systems, particularly Harmony. Strong organizational skills with attention to detail and the ability to manage multiple priorities.

Actively involve during LIMS deployment, act as LIMS admin, aware about CSV LIMS data management, Mater data creator and static maintainer for LIMS. Shall perform assessment, and supporting to investigations, deviations and implementing CAPA effectively. Overall responsible for Internal & External vendor follow ups and completions within the timelines. Responsible to procure and maintain the minimum stock for working standards, reference standards, impurity standards, chemicals, reagents, glass wares and solvents required for analysis and ordering as and when required Responsible to complete the work assigned and ensure the training on the activity which are assigned by supervisor/ HOD-QC prior execution. Responsible for completing assigned tasks and ensuring training on activities as assigned by the supervisor/HOD-QC prior to execution. Review of packing materials, raw materials, stability samples, in-process data, and finished product data. Review qualification, validation, calibration data, procedures, and audit trails in a timely manner. Identify unsafe conditions or acts in the laboratory, report them to the supervisor/HOD-QC, and ensure appropriate action is taken to address them. Receive and inward analysis samples, including packing materials, raw materials, in-process samples, intermediates, APIs, finished products, and stability samples, and log entries in the respective AR number logs. Allocate tasks for chemical and instrumentation areas, ensuring timely completion. Ensure assigned tasks align with analyst qualification reports. Review QC logs, incident reports, and other records, ensuring proper document archiving after the release of samples. Oversee control sample inspection and ensure the proper disposal of leftover samples after analysis. Ensure instrument calibration and AMC are completed as per the schedule. Prepare and revise SOPs, specifications, and procedures in line with regulatory requirements. Conduct training on SOPs, trending, and other relevant procedures. Prepare stability schedules, stability protocols, and reports, as well as validation/qualification and trending reports. Participate in investigations and ensure the effectiveness of CAPAs. Perform SAP activities and ensure QMS closure before batch releases in SAP. Actively participate during LIMS deployment, act as LIMS admin, and manage LIMS data. This includes master data creation and static maintenance. Conduct assessments, support investigations and deviations, and implement CAPAs effectively.

As a Production Chemist in the nutraceutical industry, you will leverage your 5-7 years of experience to lead the production of various products such as tablets, capsules, proteins, and pre-workout blends. Your responsibilities will include ensuring strict compliance with industry regulations and Good Manufacturing Practices (GMP), guiding formulation and development of new products, monitoring quality control processes, and collaborating with cross-functional teams to enhance manufacturing efficiency. Your expertise in nutraceutical ingredients, manufacturing processes, and quality control standards will be crucial in overseeing the production process and driving process optimization. You will be responsible for ensuring product efficacy, stability, and regulatory compliance through your deep understanding of ingredient functionality and interactions. Your role will also involve troubleshooting and resolving production issues related to blending, mixing, encapsulation, and tableting. Additionally, you will maintain comprehensive records of batch production, train and supervise production staff, and ensure that all raw materials and finished products meet defined specification requirements. To qualify for this position, you should have a Masters degree in Pharmaceutical Sciences or Food Science & Technology, along with hands-on experience in tablet and capsule manufacturing, protein and pre-workout product blending, and knowledge of GMP and regulatory requirements in the nutraceutical sector. Strong leadership, communication, and team management capabilities are essential, along with excellent troubleshooting and problem-solving skills. Preferred skills include experience with sports nutrition and pre-workout formulations, as well as familiarity with stability testing and shelf-life analysis. This is a full-time role with health insurance benefits, requiring a night shift schedule and an expected start date of 20/01/2025.,

Overview of the role: Alvotech is currently seeking a Quality Control scientist in the Microbiology Lab to join our Microbiology team in Reykjavik. QC Microbiology scientist is responsible for various microbiological testing, ensuring that the testing related to microbial analysis are conducted accurately, efficiently, and in compliance with regulatory standards, particularly Good Manufacturing Practices (GMP) to support manufacturing operations and shows thorough understanding of various techniques and microbial processes. Scope and responsibility: Performs routine microbial testing with advanced techniques to support manufacturing during 24/7 operations (shift-based work schedule). Execute endotoxin and bioburden testing Plate reading activities Sampling Environmental and Utility monitoring samples Execution of method and product verifications Management of identifications, microbial cultures and maintenance Performing routine cleaning, verification, reviews, stock checks, and upkeep of laboratory and equipment Participate as required in Aseptic Process Simulation Activities Support quality events such as CAPAs, Deviations, Change controls and laboratory investigations. Participation in the creation and maintenance of quality documents within Alvotech. Contributes to other documentation reviews and/or updates within the Quality management system, as Subject matter expect. Job requirements: BSc or M.Sc in Microbiology or relevant scientific discipline 1-5 years of experience in Pharmaceutical or Biopharmaceutical industry and a direct experience in the field of Microbiology. Strong understanding of microbial processes and regulatory compliance Good conceptual, problem solving, and organizational skills - must be detail-oriented, well organized, and able to work independently and in teams Knowledge of Good Manufacturing Practices (GMP) and documentation Rules is an asset. Proficient in using a PC and common Microsoft packages such as Word and Excel. Ability to work on a shift-based pattern work schedule What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be a part of a global and fast-growing company. An international work culture that encourages diversity, collaboration, and inclusion. Positive, flexible, and innovative work environment. Support for personal growth and internal career development. Company social events and milestone celebrations. Excellent in-house canteen and coffee house. Exercise and well-being support for full-time employees. On-site shower facility. Transportation grant towards eco-friendly modes of travel for full-time employees. Internet at home for full-time employees. Why Alvotech We at Alvotech are passionate about improving lives by increasing access to affordable biologics. We re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity, and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work, and empowered to succeed in an agile environment. True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds, regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let s create a healthier world together through affordable biologic medicines.

Overview of Role Alvotech is currently seeking a Quality Control senior scientist in the Microbiology Lab to join our Microbiology team in Reykjavik. QC Microbiology senior scientist is responsible for various microbiological testing, ensuring that the testing related to microbial analysis are conducted accurately, efficiently, and in compliance with regulatory standards, particularly Good Manufacturing Practices (GMP) to support manufacturing operations and shows thorough understanding of various techniques and microbial processes. Additionally senior scientist supports variosu projects with new product introduction, laboratory investigations and overall improvement projects within the team. Scope and responsibility Performs routine microbial testing with advanced techniques to support manufacturing during 24/7 operations (shift-based work schedule). Execute endotoxin and bioburden testing Plate reading activities Sampling Environmental and Utility monitoring samples Execution of method and product verifications Management of identifications, microbial cultures and maintenance Performing routine cleaning, verification, reviews, stock checks, and upkeep of laboratory and equipment Aseptic practices Participate as required in Aseptic Process Simulation Activities Support and lead quality events such as CAPAs, Deviations, Change controls and laboratory investigations. Creation of testing protocols and reports Participation and leading in creation and maintenance of quality documents within Alvotech. Training of personele Contributes to other documentation reviews and/or updates within the Quality management system, as Subject matter expect. Job requirements M.Sc in Microbiology and/or other relevant scientific discipline 5+ years of experience in Pharmaceutical or Biopharmaceutical industry and a direct experience in the field of Microbiology. Strong understanding of microbial processes and regulatory compliance Good conceptual, problem solving, and organizational skills - must be detail-oriented, well organized, and able to work independently and in teams Knowledge of Good Manufacturing Practices (GMP) and documentation Rules is an asset. Proficient in using a PC and common Microsoft packages such as Word and Excel. Ability to work on a shift-based pattern work schedule What we offer: An inspiring challenge to work with great co-workers on ambitious projects that change peoples lives. The chance to be a part of a global and fast-growing company. An international work culture that encourages diversity, collaboration and inclusion. Positive, flexible, and innovative work environment. Support for personal growth and internal career development. Company social events and milestone celebrations. Excellent in-house canteen and coffee house. Exercise and wellbeing support for full-time employees. On-site shower facility. Transportation grant towards eco-friendly modes of travel for full-time employees. Internet at home for full-time employees. Why Alvotech At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment. True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let s create a healthier world together, through affordable biologic medicines.

Inspect raw materials, in-process assemblies, and finished machinery to ensure quality and performance. Prepare QC reports, track non-conformities, and enforce ISO/GMP standards in production.

You will be joining Sohan Healthcare Private Limited in Daund as a full-time QA Manager. In this role, you will be responsible for overseeing the quality assurance processes, conducting internal audits, ensuring compliance with regulatory requirements, managing quality control activities, and implementing quality improvement initiatives. Your expertise in Quality Assurance, Quality Control, and Regulatory Compliance will be utilized to uphold the highest standards of quality at Sohan Healthcare Private Limited. To excel in this role, you should possess experience in conducting internal audits and implementing quality improvement initiatives. An in-depth understanding of GMP, GLP, and other relevant quality standards will be essential. Your strong analytical and problem-solving skills will enable you to address quality assurance challenges effectively. Attention to detail and accuracy in quality assurance processes will be crucial to ensure the products meet the required quality benchmarks. Excellent communication and interpersonal skills are key as you will collaborate with various teams within the organization and external stakeholders. A Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field is required for this role. Additionally, certification in Quality Management or Quality Assurance would be advantageous in demonstrating your expertise in ensuring quality compliance. Join Sohan Healthcare Private Limited and contribute to maintaining the reputation of the company as a leading manufacturer specializing in Active Pharmaceutical Ingredients, Semi-finished Formulations, and Finished Dosage Forms for the global market.,

The ideal candidate will have a consistent record of leadership in technology-driven environments using 3DEXPERIENCE Cloud platform and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the customers feel informed and engaged Lead and manage large, diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Responsible for managing, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Understand the decision-making process, workflows, and business and information needs of business partners and collaborators Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in collaborator and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Facilitate standard process sharing, ensuring ongoing alignment with the Technology & Digital strategy Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 12 to 17 years of experience in Business, Engineering, IT or related field . Preferred Qualifications: Functional Skills: Must-Have Skills: Strategize, plan, and implement various phases of PLM roadmap using Dassault Systemes 3DEXPERIENCE platform and integrating with key enterprise platforms Strong Technical/Functional experience solutioning and supporting GMP applications across Engineering, Clinical, Commercial and Quality functions. Demonstrated hands-on experience in managing technology solutions involving one of the leading PLM solutions (Windchill, Teamcenter or 3DEXPERIENCE). Experience integrate PLM with enterprise systems such as Data Fabric, Veeva vault, SAP, MES and SCADA systems. Experience in people management and leading highly skilled matrixed teams, passion for mentorship, culture and fostering the development of talent. Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Exceptional collaboration, communication and interpersonal skills to effectively manage collaborator relationships and build new partnerships. Experience in applying technology standard process methodologies: Scaled Agile (SAFe) Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Experience with configuring and customizing solutions for Requirements, CAD, Risk, EBOM, MBOM, Configuration/Variants, Recipe, MPP, Document and Change management. Experience leading data migration from various sources to 3DEXPERIENCE platforms. Experience creating solutions using Enterprise Integration Framework and usage of middleware systems such as Mulesoft, Boomi or Tibco. Extensive experience in software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business stakeholders Broad working knowledge of key IS domains and layers Professional Certifications: Scaled Agile Framework (SAFe) for Teams (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams

Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and comply with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Lead, mentor and coach junior Quality and Validation engineers in their activities Analyze test results, collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution. Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), Validation Reports, deviations, change control, non-conformance and other Computer System Validation (CSV) documents. Ensure validation strategies meet regulatory requirements and company standards. Guide junior validation engineers in writing the CSV documents and verify their output for completeness, accuracy and quality. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Lead test automation scripting, framework maintenance, and CI/CD integration. Develop and execute automated test suites across various modules in 3DEXPERIENCE. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Involve actively in release planning and estimate test efforts. Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of Software Quality and GMP Validation . Must-Have Skills: Experience in Quality Assurance (QA) testing with at least 6 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions. Strong experience in manual and automated testing for complex applications, especially in the 3DEXPERIENCE platform. Experience in Computerized System Validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc. ). Experience in QA & Test Automation is expected. Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Hands-on experience executing and analyzing automated test suites Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points Experience with automated and computer-controlled systems validation (21 CFR Part 11) Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills.

-This is a universal job description meant to capture some of the primary duties of this role that are common across functions or divisions. It is not intended to represent all of the specific responsibilities of the position -Management TrackLead and manage the Engineering, Logistics and Safety Experts team inthe Local Supply Center to ensure deliveries of intermediates anddrug substance, maintaining compliance with internal and externalregulatory and quality standards(GMP and HSE) and budget targets. Responsible for maintenance and investment budgets and long terminvestment plan for DSS. TRD Representative for Engineering for Rhinetal Valley. -Scientific / Technical TrackHas operational end to end responsibility for assigned supply activities. Leads and manages complex and demanding projects and global network activities and participates in cross-functional teams. Accountable for performance improvement initiatives. -Produces, packages and manufactures drugs to be used in clinical trials. Responsible for distribution, warehousing, transportation, packaging, randomization, blinding, and labeling of material for clinical trials in conformity with guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). -To oversee clinical supply on holistic global trials level, proactively negotiates and communicates clinical supply plan/timeline to internal and external customers and partners. About the Role Major accountabilities: Management Track. Lead projects or campaigns or proactively drive project execution. Set key milestones and /or ensure project progress, quality and budget adherence. Act as unit representative on or lead development teams and/or other cross functional teams. Ensure governance process is in place to be compliant to Novartis and other relevant regulations. Writing and reviewing of SOPs. Coaching senior associates in technical and leadership area. Act as mentor for senior associates globally. Perform role of facilitator/mediator in difficult scenarios. Provide strong input into OTR process and Talent Management. In close cooperation with the Unit Head, drive the unit long term strategic plan and its implementation. Ensure current and future needs are fully met, unit projects are assigned, adequately resourced, delivered on time and in full compliance. Manage resource constraints and lead cost saving opportunities. Being accountable for a large budget (Project, infrastructure, plan maintenance). Scientific Track. Coordinates internal and external stakeholders, customers and /or vendors and performs stakeholder management. Lead projects or campaigns or proactively drive project execution. Set key milestones and/or ensure project progress, quality and budget adherence. Act as unit representative on or lead development teams and/or other cross functional teams. Communicate issues to teams and line management in a proactive way and propose corrective actions and mitigation plan. Organize and ensure regular lessons learned sessions and follow up on actions. Coaching and technical training as recognized technical expert or leader. Act as mentor for junior and senior associates (academics) globally. Perform role of facilitator / mediator in difficult scenarios. Understand resource constraints and identify and lead cost saving opportunities. Being accountable for a medium budget (Project, infrastructure, plan maintenance). Ensure own and other team members compliance to Novartis and other relevant regulations. Writing and reviewing of SOPs. Consolidate data evaluation and propose solutions / risk mitigation plans -Act as role model for cultural evolution within TRD. Being accountable for global process improvement as leader or member. Drive implementation and sustain phase in and outside expertise / organization. Oversees clinical supply projects on holistic global trials level, proactively negotiates and communicates clinical supply plan/timeline to internal and external customers and partners. Reviews clinical trial protocol and provides input to drug sections. Develops packaging design matching the study design, which ensures optimized supply plan in terms of cost, feasibility and overage for own studies and guides and coaches other Trial managers regarding best possible design. Applies simulation tools to drive optimal clinical supply plan, adequately supports studies. Drives the development and use of simulation technique with ex Key performance indicators: Management Track -Drive the planning, coordination, and execution of all people management processes in the unit, including performance management, training, and development planning. Partner with the Development and Education Office (DEO) to identify and devise unit training opportunities, addressing both strategic and behavioral needs while taking into account suitable metrics to quantify training success. Drive a culture of excellence in knowledge sharing. Provide strong input into OTR process and Talent Management. Develop, monitor, and report on Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken. Permanent measurement, benchmarking, and continuous improvement of KPI for the unit. In close cooperation with the Unit Head, drive the unit long term strategic plan and its implementation. Ensure current and future needs are fully met, unit projects are assigned, adequately resourced, delivered on time and in full compliance. Scientific / Technical Track. Quality (GMP), quantity, and timelines for all assigned tasks/projects. Compliance with Novartis standards, in particular, ethics, health, safety, and environment (HSE), and information security (ISEC) standards. Unit KPIs (e. g. FPFV (first patient first visit), LTA (lost time accident), FTR (first time right), Rework Rates, Recalls). Cross functional and TRD KPIs . Minimum Requirements: Work Experience: Collaborating across boundaries. Representing the organization. People Leadership. Skills: Continual Improvement Process. Master Data. Material Requirements Planning (Mrp). Materials Management. People Management. Production Planning. Project Management. Supplier Relationship Management (Srm). Supply Chain Planning. Supply-Chain Management. Technical Requirements. Wms (Warehouse Management Systems). Languages : English.

Summary -This is a universal job description meant to capture some of the primary duties of this role that are common across functions or divisions. It is not intended to represent all of the specific responsibilities of the position. -Has operational end to end responsibility for assigned supply activities. Leads and manages projects of different complexity and local network activities and participates in cross-functional teams. -Produces, packages and manufactures drugs to be used in clinical trials. Responsible for distribution, warehousing, transportation, packaging, randomization, blinding, and labeling of material for clinical trials in conformity with guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). -Has operational end to end responsibility for assigned supply activity. Leads and manages demanding projects and network activities and participates in cross-functional teams. About the Role Major accountabilities: Contributes as unit representative on project teams. Ensures that own deliverables are met. Interprets results, evaluates data, draws conclusions and reports back to team and management -Coordinates internal and external stakeholders, customers and/or vendors and performs stakeholder management -Proactively drive project execution to ensure key milestones and quality are met -Act as unit representative on development teams and/or other cross functional teams -Communicates issues involved stakeholders and to teams and line management and propose corrective actions -For GMP units: ensure compliance to cGMP -Organizes and ensures regular lessons learned sessions -Coaching and technical training as recognized technical expert or leader. Act as mentor for junior and senior associates (academics) also globally -Understand resource constraints and identify and lead cost saving opportunities. Might be accountable for a minor budget -Ensure compliance to Novartis and other relevant regulations. Writing and reviewing of SOPs. As process owner being accountable for process improvement. Drive implementation and sustain phase within area of expertise -Consolidate data evaluation, propose solutions and contribute to risk mitigation plans -Act as role model for cultural evolution within TRD -Being accountable for process improvement as leader or member. Drive implementation and sustain phase in and outside expertise / organization. Support cultural evolution within own function by showing positive work ethics and influencing others. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Adherence to costs, quality (GMP), quantity, and timelines for all assigned tasks/projects -Compliance with Novartis standards, in particular, ethics, health, safety, and environment (HSE), and information security (ISEC) standards. Unit KPIs (e. g. FPFV (first patient first visit), LTA (lost time accident), FTR (first time right), Rework Rates, Recalls) -Cross -functional KPIs (if applicable) Minimum Requirements: Work Experience: Functional Breadth. Managing Crises. People Challenges. Collaborating across boundaries. Operations Management and Execution. Project Management. 3-4 years relevant experience. Skills: Continual Improvement Process. Master Data. Material Requirements Planning (Mrp). Materials Management. Production Planning. Project Management. Supply Chain Planning. Supply-Chain Management. Technical Requirements. Wms (Warehouse Management Systems). Languages : English.

1. Responsible for calibration & Schedule activities of the field instruments activities. 2. Hands on experience in DCS operations, Calibration activities, CSV and Documentation activities. 3. Experience on DCS systems Hardware configuration, termination as per wiring drawings, cold loop checking, Hot Loop checking and field instruments configuration and communication. 4. Experience on rectification of process equipment like Reactors, ANFD, VTD etc. 5. Temperature Mapping & its Documentation. 6. Responsible for the preventive maintenance and breakdown issues. 7. Experience on Reactor utility automation, Solvent Dispensing System, pH adjustments. 8. Installation and maintenance of Temperature Transmitters, Pressure & Level Transmitters & Level controllers. 9. hands on experience on Qualifications like IQ, OQ and preparation of qualification documents. 10. Experience on Qualification Documents for the PLC, SCADA & HMI and QMS activity and executing the task in CCPs, CCTs. Deviations related activity like CAPA, risk assessmentsEtc. 11. Experience in handling of Team.

Ensure adherence to quality standards and regulatory requirements throughout the manufacturing and packing processes Deep understanding of pharmaceutical quality assurance practices. Prior experience in pharmaceutical or quality assurance preferred. Required Candidate profile Knowledge of GMP regulations and quality systems. Effective communication and interpersonal skills. Proficiency in MS Office applications (Word, Excel). Flexible with shifts.

Prior experience in pharmaceutical manufacturing or quality assurance preferred. Knowledge of GMP regulations and quality systems. The IPQA Officer will play a crucial role in ensuring that all manufacturing and packing activities Required Candidate profile Strong attention to detail and excellent organizational skills. Effective communication and interpersonal skills. Proficiency in MS Office applications (Word, Excel). Flexible with shift.

Filling & review BMRs, MFRs, SOPs, ECR Maintain records for CC, CCF Ensure documentation aligns with GMP Requirement Support audits & investigations with accurate records. Coordinate with production & QA for data verification. Required Candidate profile Must Require Knowledge for filling & Review of BMR BMR, CC, CCF, and OOS handling Documentation practices & regulatory understanding Good communication & MS Office proficiency

Safety roles within pharmaceutical or chemical industries; experience in a pellets manufacturing setup is preferred. OSHA, WHO-GMP, NDMA guidelines, Risk Assessment tools (HAZOP, JSA), ETP operations Proficiency in MS Office, Safety Audit Tools. Required Candidate profile Conduct risk assessments (HIRA, JSA) control dust generation and potential explosion risks occupational health, process safety, fire prevention, and statutory compliance Flexible with the shifts .

Computer proficiency, Excellent knowledge in HACCP & GMP, working in freezers & chillers, staying late for night closing, with difficult customers, shift flexibility. Quality of all products, food safety. Training TMs & CTMs on food safety.

WHO-GMP guidelines, pharmaceutical material handling, inventory systems (ERP/SAP) Material handling, storage, and movement comply with WHO-GMP Strong expertise in pharmaceutical warehousing, inventory control, regulatory compliance, cross-functional. Required Candidate profile Lead day-to-day warehouse operations receipt, storage, issuance, and dispatch of raw materials, packaging materials, intermediates, finished goods. Relevant experience in a pharmaceutical warehouse

5-10 years experience in plant operations, administration, or security coordination in a manufacturing Emergency handling, shift supervision. -Experience as Night Managers - Ability to handle emergency situations - Preferably retired forces personnel Required Candidate profile Graduate in any discipline (preferably Science/Engineering/Pharmacy). Proficient in both English and local language. Must reside near the plant Must have two-wheeler/four-wheeler Night Shift