1682 Gmp Jobs - Page 4

Job Description: Role : Executive Microbiologist Location : Hyderabad Job Purpose/Overview To ensure the Dry Pet Food products leaving the factory operation confirms to the MARS specifications through the assurance of raw materials quality & compliance to process parameters by demonstrating quality inspections, process monitoring & control through microbiological testing of samples. The Microbiologist shall assist the Quality control lab manager in managing the Laboratory (microbiology) in terms of executing test plans in timely manner, follow GLP, & cost optimization. Shall participate & support effectively in design & implementation of Food Safety Quality Management Systems (HACCP) and essential Pre-requisite programs (PRPs) for Dry Pet food plant. Job Responsibilities 1. Plant Responsibilities: o Conduct analysis of incoming raw materials, Finished products as per Microbiological test plan. o Conduct routine microbiological tests as per the Mars Micro verification standard. o Communicate the status of materials or products for release/hold/ rework/ reject o Ensure effective implementation of personal-plant hygiene, cleaning & sanitations programs in line with GMP standard o Ensure Calibration the laboratory testing & measuring equipment s as per calibration plan o Conduct microbiological analysis for intermediate products & finished products as per test plan o Learn & implement new testing methods, as required. o Track & report the microbiological performance using trend charts , suggest & follow up corrective & preventive actions o Maintain Lab testing data and relevant test records. Ensure timely completion of all testing and documentation. o Conduct Environmental Monitoring of plant by taking Swabs samples, Air Monitoring and water testing. 2. Suppliers Interface: Track supplier performance basis raw materials quality, microbiological contaminations, handle non-conformities & record Communicate materials/ suppliers related issues to Supply chain and follow up Conduct/ Co-ordinate analysis of Shelf life samples, Market samples & Concerned samples to track product performance and feedback Co-ordinate/ facilitate with external testing laboratories for analysis & records 3. Support Quality & Food Safety Systems: Support effective implementation of HACCP in the plant by ensuring cleaning sanitation. Assist in designing MRAs for raw materials by sharing the analysis outcomes. Support in CCP/OPRP verifications wherever applicable through Microbiological Samples collections, Testing and reports sharing. Support in GMP verifications at site. 4. Other Responsibilities: Demonstrate GLP & support Lab cost optimization initiatives Conduct Associate on-job and classroom training on Food Safety Management. Focus on personal-plant hygiene, cleaning & sanitation plans. Quality- Associate is responsible to ensure effective implementation of Mars QMP (Quality Management Process), Quality and Food Safety requirements including Personnel Hygiene and GMP stated by the Organization as applicable. Associate shall deliver through Respective Area/Process Standard Operating Procedures. Meet basic competency requirements mentioned in the job Role Skill Matrix to ensure Quality and Food Safety requirements are implemented to satisfactory level. SES-Overall responsibility to ensure the individual compliance to Mars Global/Asset conservation standards and other relevant local SES legislation. Responsible for implementing and maintaining all relevant SES Management systems in their respective work area. Responsible for understand risks and controls in their area, get appropriate training, report all incidents and ensure that SES objectives are captured as KRAs in TMS The incumbent would work collaboratively with other Executives Microbiology for supporting the deliverables of the Lab He/She would act along with other Executives Microbiology as interface to Suppliers related to Microbiology testing Media procurement, PCR vendors and External microbiology labs. Job Specifications/Qualifications 1. Educational & Professional Qualification MSc- Microbiology or B. Tech with Microbiology Knowledge/Experience 3-4 years experience in microbiology Lab Required experience with Food/ Pharma Company

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Planning and executing various analytical method development, validation for new products, comprehensive testing of API and finished dosages with all established regulatory and compliance and safety requirements. Review of laboratory data, instrument logbook and reports wherever applicable. Initiation of departmental CCRs and tracking the progress to execute the proposed changes through QMS system. Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites. Preparation, maintenance and archival of regulatory submission documentation like SOP, protocols, reports for method development and validation. Job Responsibilities Prepares working plan for assigned projects and provides timeline to Manager. Develops stability indicative analytical methods for drug substance and finished product Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems. Applies AQbD approach to analytical method development where applicable. Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters. Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines. Responsible for method verifications and publishing of analytical methods. Maintenance and archival of analytical method validation documents. Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation. Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution. Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing. Conducts other tests required for dosage submissions. Conducts lab investigations for OOS and OOT results. Raising Change control for various analytical activities (Method SOP and department SOPs) by QMS trackwise To prepare General, Operation and Calibration Standard Operating Procedures. Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable. Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor. Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes. With minimal guidance, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products. To participate in the mandatory trainings to execute the day to day job responsibilities. Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP. Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time. Practice and up-gradation of knowledge with respect to cGMP. Performs all work in accordance with all established regulatory and compliance and safety requirements. Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements. Ensures all instruments assigned with responsibility within group/department are well maintained. Performs the calibration of instruments in Analytical R&D and ensures the compliance as per cGLP requirements. Work as a member of a team to achieve all outcomes. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Job Requirements Education A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field. Knowledge, Skills and Abilities knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques. Knowledge in HPLC method development and method validation. Knowledge on preparation and review of various documents like SOPs, Formats, Protocols, Reports, analytical data, investigation and deviation reports. Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities Should possess troubleshooting knowledge on Instruments and analysis. Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems. Working knowledge of LIMS is an asset. Good written and verbal English communication skills. Experience BSc with 5 years or MSc with 4 years or PhD with 2 years experience in a pharmaceutical lab in an R&D environment. Chromatographic method development and validation. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Required Skills: Strong coping, emotional resilience, and stress-management skillsExcellent comprehension and communication Ability to perform duties objectively, devoid of inherent biases or personal beliefs, in the best interest of client policies Strong attention to detail Comfort synthesizing and analyzing information from multiple streams Strong critical thinking and decision-making skillsLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Good Communication Skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance New Associate Qualifications: BCom Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Commitment to qualityAdaptable and flexibleAbility to work well in a teamAgility for quick learningAbility to meet deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification BCom

Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and maintaining a proactive approach to mitigate the risk of engaging with sanctioned entities. What are we looking for Commitment to qualityCollaboration and interpersonal skillsAbility to work well in a teamAbility to perform under pressureAbility to meet deadlines Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom

The candidate will be responsible for the proper receipt, storage, and GMP-compliant dispensing of raw materials used in pharmaceutical production Perform raw material dispensing activity in designated dispensing booths under controlled conditions.. Required Candidate profile Receive, inspect & label incoming raw materials as per SOP Coordinate with the QA, Production & QC department during material movement Ensure adherence to GMP, GDP & safety guideline during dispensing

Assist in maintaining QMS and documentation (SOPs, BMRs, audit reports). Support internal and external audits. Learn GMP compliance and regulatory guidelines. Coordinate with QA and other teams to ensure smooth quality processes.

Support QMS implementation and maintenance. Conduct internal/external audits, including customer & regulatory. Prepare audit docs, handle vendor/customer questionnaires. Coordinate with teams to ensure GMP. Report deviations, OOS, and assist in CAPA.

Candidate needs to handle all shop floor responsibilities of plant which includes batch and shift schedules preparation, planning and execution of batches, GMP documentation compliance, support in GMP audit compliance and investigation team

Job Title: Quality Engineer. Experience: 4 to 10 years Location: Mysuru Notice Period: immediate to 15 days Mandatory Skill: QMS, Capa, GMP/Gdp/ GLP, Change Control, Deviation, Sop Preparation JD : Good understanding of Pharmaceutical GMP/GLP/GDP practices. *Experience in Pharma QMS activities like, handling Change Controls, Deviations, vendor qualifications and SOP updates. *Understanding of Internal Audits and CAPA closures. *Supporting for Quality metrics program. *Proficient experience with MS-office is required. *Strong written and verbal communication skills are essential *Experience working with virtual teams • Understanding of ISO 9001:2015 is required. *Strong communication, teamwork, data analysis, inductive reasoning and root cause analysis skills are required.

Role & responsibilities Company: Cravicious Foods Pvt Ltd Job Title: Packaging In charge / Packaging Supervisor Location: Greater Noida Key Responsibilities: Supervise and coordinate daily packaging operations for frozen chicken products. Ensure adherence to quality standards, safety protocols, and hygiene regulations. Monitor packaging line performance and troubleshoot issues to minimize downtime. Maintain accurate documentation related to packaging processes, batch codes, and quality checks. Lead and train packaging staff to ensure compliance with company standards and procedures. Collaborate with production and quality control teams to ensure timely delivery of packaged products. Implement continuous improvement initiatives to enhance packaging efficiency and safety. Ensure proper handling, storage, and disposal of packaging materials. Conduct regular inspections to maintain cleanliness and sanitation of the packaging area. Preferred candidate profile Bachelor's degree or diploma in Food Technology, Packaging Technology, or a related field. Minimum 2-5 years of experience in packaging, preferably in the food industry or frozen food sector. Knowledge of food safety standards and GMP (Good Manufacturing Practices). Strong leadership and team management skills. Experience with packaging machinery and equipment used in food manufacturing. Familiarity with HACCP, ISO, or other food safety certifications. Attention to detail and quality-oriented mindset.

Issuance & retrieval of BPCRs/ ECRs/ formats/ log books etc. Preparation of QA SOPs and list of SOPs. Follow-up cross functional team for periodic review and review of other departmental SOPs as and when required. Distribution of controlled documents e.g. SOPs, specification etc. QC Analytical Raw data and sampling and review checklist Issued. Ensure all the activities comply with EHS regulations and policies. Ensure Zero accident / Incident at work place Ensure all the activities / documentation as per the cGMP guideline

Role & responsibilities Industry Preference: Food, Beverages, FMCG Strong knowledge of GMP, HACCP, and GHP standards Hands-on experience in production operations Expertise in handling non-conforming products and implementing corrective actions Well-versed with quality checking parameters for teabags and pouches Sound understanding of Product Recall & Traceability systems Knowledge of product labeling regulations and compliance Skilled in online quality checks , root cause analysis, and CAPA implementation Proficient in quality documentation , including record-keeping for audits Good exposure to Food Safety standards and practices Proven team handling experience (minimum 3-4 years) in production/quality environments Must Haves: Bachelors degree / Diploma in food technology, Production Engineering, or a related field. Min 3-8 years of experience in QA/QC roles in FMCG/Food/Beverages industry. Knowledge on GMP. Handling of non-conforming product. Quality checking Criteria of teabag / pouch. Good to Haves: Exposure to the tea industry. Familiar with ISO 9001: 2015. Proficiency in tools such as MS Office .

* Implement and manage production processes for injectable DPI and liquid injection product. * Ensure all operations comply with GMP and regulatory requirements. * Prepare daily reports and update process documentation consistently Required Candidate profile * Knowledge of Peptide synthesis, Purification & Lyophilization operation. * Operation of reactor, Nutsche filter, centrifuge * Handling experience of equipment Lyophilizer and Autoclave

As an Executive / Senior Executive in Quality Control (QC), you will play a crucial role in ensuring that products consistently meet the defined quality standards of the company. Your responsibilities will include conducting quality testing of raw materials, in-process, and finished products as per Standard Operating Procedures (SOPs). It will be your duty to identify, document, and escalate any non-conformities or deviations found during testing, while maintaining thorough and accurate records of test results, logs, and batch documents. Your role will also involve ensuring alignment with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory requirements. Collaboration with the production team to troubleshoot and resolve quality-related concerns will be essential. Moreover, you will be preparing and assisting in internal and external audits as well as regulatory inspections. Monitoring key quality metrics and providing inputs for process improvements are also part of your responsibilities. To excel in this role, you should have 2 to 5 years of experience in QC roles within the cosmetics, pharmaceutical, or FMCG industries. A strong technical understanding of quality control protocols, lab equipment, and analytical techniques is necessary. Knowledge of regulatory frameworks such as ISO, WHO-GMP, and FDA will be beneficial. Your detail-oriented mindset, coupled with strong documentation and analytical skills, will be key to success. Proficiency in handling quality management systems (QMS) and MS Office is essential. Effective communication and interpersonal abilities will also be valuable in this position.,

Supplier Quality Data Analyst Duration: Sept 1, 2025 Nov 30, 2025 Location: Remote (Bangalore, India-based) Work Hours: 40 hrs/week, 8 AM – 5 PM EST (flexible) Interview Process: 1 Virtual Round Team: Global Supplier Quality – Operations Pay: 12/hr USD – (41,000 to 42,000/week in India) Role Overview The selected candidate will support the Global Supplier Quality Operations Team with a 50/50 focus on data analytics and quality documentation within a GxP / GMP-compliant environment , using Veeva and Excel-based systems. Responsibilities Maintain and update weekly KPI reports , quarterly performance reports , and supplier quality data sets . Handle supplier qualification documents , including ISO , GxP , and GMP certificates. Monitor expiration dates and request renewals from suppliers. Pull weekly data from supplier quality systems , analyze for errors, and track performance metrics. Manage and track supplier change requests . Upload, monitor, and maintain documents using Veeva software. Conduct data assessments , error tracking , and assist in compliance reporting. Work closely with cross-functional teams during on-the-job training and process ramp-up. Must-Have Skills & Requirements 3+ years experience in documentation or data quality support roles. Strong hands-on experience with MS Excel (reporting, error-checking, formatting). Familiarity with GMP / GxP / ISO compliance environments (Pharma or Medical Device preferred). Working knowledge of Veeva or similar document control systems. Ability to read and understand specifications and track supplier compliance . Comfortable handling data integrity , compliance documentation, and internal reporting tasks. Working 50% Quality Documentation & Compliance 50% Data Analytics & Reporting

Job Summary As a Team Member in the Instrumentation section at Dr. Reddys Laboratories Ltd., your primary responsibility will be to coordinate breakdown activities, improvement activities, and preventive maintenance schedules. You will oversee external contractors, ensuring compliance with safety and quality standards. Your role will involve reviewing production operations, training team members, managing spare parts inventory, and leading troubleshooting efforts to minimize downtime. Additionally, you will be responsible for maintaining budgets, supporting technical activities, and ensuring regulatory compliance to contribute to the efficient and reliable operation of instruments, equipment, and facilities. Roles & Responsibilities - Coordinate with cross-functional team members to ensure improvement activities and preventive maintenance schedules are carried out in SAP. Maintain necessary records and plan preventive maintenance activities according to defined frequencies. - Oversee external contractors and agencies to ensure compliance with safety and quality standards during maintenance operations. - Review production operation instructions such as work instructions (WI) and standard operating procedures (SOPs) to ensure implementation and adherence to quality standards. - Train and assist team members during troubleshooting, breakdowns of machines, and commissioning of new equipment to enhance technical skills and capabilities. - Manage spares inventory for all instrument spare parts, conduct balance investigations, and implement inventory control measures for availability of necessary parts. - Lead troubleshooting efforts for all instrumentation-related breakdowns, identify root causes, and implement corrective actions to minimize downtime. - Plan and consolidate maintenance budgets for the assigned area/unit, ensuring expenses are within budgeted amounts and optimizing cost-effectiveness. - Maintain spares for process equipment by coordinating with OEMs, external vendors, and supply chain management to ensure timely availability. - Ensure timely closure and completion of assigned corrective and preventive actions (CAPAs) to address maintenance issues and improve operational efficiency. - Provide support for technical and documentation activities at the site as directed by the Section Head, ensuring compliance with regulatory requirements. - Prepare, update, and maintain all necessary documents for audits, including SOPs, formats, PM books, protocols, and machine history books, to ensure compliance with GMP and cGMP standards. - Implement Good Engineering Practices at the site to maintain the reliability, safety, and efficiency of instruments, equipment, and facilities. Qualifications Educational Qualification: Diploma or Bachelor's in Engineering Minimum Work Experience: 8-10 years of experience in the pharmaceutical industry with a focus on maintenance and engineering. Skills & Attributes Technical Skills: - Prior experience in maintenance and engineering roles preferred. - Strong understanding of preventive maintenance practices and procedures. - Proficiency in SAP or similar maintenance management systems. - Ability to lead troubleshooting efforts and implement corrective actions effectively. - Knowledge of regulatory requirements, including GMP and cGMP standards. Behavioural Skills: - Attention to detail and strong organizational skills. - Ability to work collaboratively in a cross-functional team environment. - Excellent communication and interpersonal skills. Dr. Reddys Laboratories Ltd., a global pharmaceutical company, is committed to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we operate state-of-the-art manufacturing plants across various locations, delivering quality medicines to patients worldwide. Join us in our mission to accelerate access to affordable and innovative medicines because Good Health Cant Wait. For more information, visit our career website at https://careers.drreddys.com/#!/,

As a Senior Regulatory Affairs Associate at our organization, you will play a crucial role in managing regulatory documentation, resolving technical queries from clients, and supporting vendor qualification processes. With a solid background in the Pharma raw material industry, particularly in excipient products, you will leverage your expertise to ensure compliance with regulatory standards and guidelines. Your responsibilities will include handling all regulatory documents related to excipients, addressing technical queries from pharmaceutical clients, managing technical matters and documentation for excipient manufacturers, and preparing technical documents for the promotion of excipient products. Additionally, you will be expected to provide specific technical documents for manufacturer and product qualification, manage regulatory qualification documents and queries, and coordinate with overseas excipient manufacturers. To excel in this role, you should possess good technical knowledge regarding guidelines, GMP, and testing methods for excipients, along with experience in vendor management. A minimum of 2+ years of experience in a regulatory and data role, as well as team management experience, is required. Candidates with a background in Pharma and experience in team handling will be given preference. This position offers competitive remuneration and benefits, and if you believe you have the necessary skills and experience to succeed in this role, we encourage you to apply. We look forward to connecting with you and potentially welcoming you to our team at CLYZO.,

Reporting to the Senior Manager International Quality JAPAC, the responsibilities of your role will cover, but are not limited to the following: Main Responsibilities Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality - JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier Management: Perform quality oversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers , contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Win What we expect of you Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus Thrive What you can expect of us As we work to develop treatments that take care of others, we work to care for our teammates professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Let s do this. Let s change the world. In this vital role you will be a skilled Software Test engineer to develop, implement and maintain the test scripts for data platforms and custom-built solutions. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Front-end testing, Back-end testing, API testing, and test automation. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products follow the required validation processes, documentation, and align 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, Database, and Beta. Actively involved in release planning and estimate test efforts Collaborate and test in an Agile development environment Analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Contribute to test automation scripting, framework maintenance, and CI/CD integration. Implement automated test suites across various layers including data pipelines, APIs, and semantic layers. 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. Work closely with manager on implementing automation strategies, document all bugs in a tracking tool, and always follow the best QA practices Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Identify opportunities for process improvements in validation activities. Stay ahead of on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master s degree and 1 to 3 years of Computer Science, IT or related field experience Or Bachelor s degree and 3 to 5 years of Computer Science, IT or related field experience Preferred Qualifications: Must-Have Skills: 3+ years of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 6-8 Years overall experience in Testing & Validation Projects 2 to 4 years overall experience in QA & Test Automation is expected. Experience leading software validation projects. Proficiency in developing and implementing validation protocols (IQ, OQ, PQ), reports, and related documentation. Hands-on experience implementing and analyzing automated test suites Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and collaboration skills. Good-to-Have Skills: 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 balance 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. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products 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: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. 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. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 5 + year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 8-10 Years overall experience in Testing & Validation Projects Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor s degree in computer science and engineering preferred, other Engineering field is considered 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.

We seek a skilled Validation Lead to oversee and manage validation activities for data platforms and solutions . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data and analytics products 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: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of data products and software applications . Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Write, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. 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. T rack the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management . Identify opportunities for process improvements in validation activities. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams. Functional Skills: Must-Have Skills: 2+ year s of experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.). 5+ to 9 Years overall experience in Testing with 2+ years of experience in validation experience is mandatory. Experience leading software validation projects. Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Familiarity with computer system validation and software validation is a plus. Strong problem-solving and analytical skills. Excellent communication and teamwork skills. Good-to-Have Skills: Experience with automated and computer-controlled systems validation (21 CFR Part 11) Education and Professional Certifications Bachelor s /Masters degree in computer science and engineering preferred, other Engineering field is considered 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.

Career Category Information Systems Job Description Let s do this. Let s change the world. In this vital role you will be responsible for developing and leading a highly talented team that is built for delivering high-end and innovative technologies. 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 What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. In this vital role you willbe serving patients through internal collaboration with Amgen s global quality teams, manufacturing sites and external engagement with contract manufacturing organisations. You will make key contributions to ensure high quality and right first time materials are received at the Amgen, build a resilient supply network and conclude with a positive patient experience. In this role you will be part of Amgen s Global Supply Quality team supporting oversight and maintenance of contract manufacturers. Roles & Responsibilities: Working independently, the individual will be responsible for, but not limited to the following: Enter analytical into LIMS Create and update LIMS sample plans Generate Certificate of Analysis Compile batch release documentation Perform QA Approver role on the Quality Events Initiate Quality records for supplier related changes Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Take part in operational and quality improvement initiatives, programs, and projects. Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs. This role may require working in shifts or extended hours within the same shift to support global timezones. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Master s degree and 1 to 3 years of professional experience in related fields OR Bachelor s degree and 3 to 5 years of professional experience in related fields OR Diploma and 7 to 9 years of professional experience in related fields Understanding GMP/GDP requirements. Familiarity with raw material compendial testing Experience overseeing quality of suppliers or external parties Strong technical writing skills Preferred Qualifications: Experience and strong familiarity with digital tools and computerized systems. Strong continuous improvement attitude and lean practices experience. Understanding of end-to-end supply chain business processes. Experience in project management across multiple departments and geographies. Quick process understanding, insight and visualizing. Strong analytical and problem-solving skills. Independent self-starter, able to work autonomously, under pressure and in teams. GMP/GDP knowledge and understanding of pharmaceutical regulations. Energetic, detail oriented, highly motivated with a can do outlook. Change management skills. Ability to communicate across all levels of the organization. Effective written and verbal communication skills. Experience with Microsoft Office Tools including Excel, Word, and PowerPoint. Ability to multi-task and prioritize Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.