2128 Change Control Jobs

Purpose/Objective Officer - Safety is responsible for implementing QSHE (Quality, Safety, Health, and Environment) policies and procedures, identifying and mitigating risks, and ensuring a safe and healthy work environment. The role involves auditing, investigating incidents, and providing safety support and guidance to line managers, as well as ensuring compliance with relevant statutory requirements. Key Responsibilities of Role Safety Program Implementation: Implement Safety policies and procedures in the allocated area, ensuring adherence to company and industry safety standards. Safety Objectives & Action plans: Advise and assist line managers in planning, organizing, and maintaining a ...

Role & responsibilities QMS Related Activity: - 1. Handling of market complaint investigation, documentation and follow-up and reports closure 2. Handling of CAPA & change control activity. 3. Issuance, control and retrieval or batch records, SOPs, Logbook, and other documents. 4. Prepare and review Annual product quality review. 5. Management of control sample room. 6. Preparation and review of SOP. IPQA Related Activity: - 7. To take shop floor round and do gap analysis between practices followed vs GMP practices. 8.. To review all executed BMR, BPR and Final Batch Release of Finished Product in SAP for Sale or Distribution. 9.To perform line clearance and In-process checks in manufacturin...

USV (Pharma) is Hiring Senior Manager - QA (Sterile) for USFDA Formulation Manufacturing Plant based at Daman near Vapi. We are looking for dynamic professionals having more than 15 years of experience in hard core injectables (Liquid Vials, Ophthalmic and Pre-filled syringes). The incumbent must be having the thorough knowledge of IPQA, Qualification and Validation, QMS Aseptic techniques and practices. Should have faced the Regulatory Audit (USFDA, MHRA, EU GMP, TGA) and should be able to explain the auditors during inspections. Excellent verbal and written communication are expected. Oversee and manage QMS processes including Deviation Management, CAPA, Change Control, Risk Management, an...

JD: Evaluation of the change controls. Drafting and sending the change notification to customers till its implementation. Skills required: Good understating life cycle management in API regulatory affairs Clarity on regulatory guidance documents on post approval changes Experience in drafting/reviewing the Module 3 of API

Role Overview: Join EY as a Regulatory Compliance Senior in the Enterprise Risk team where you will assist clients by understanding their business needs and delivering solutions in line with EY guidelines. Your role involves establishing and maintaining relationships, driving projects to completion with high-quality deliverables, and leading internal initiatives to achieve operational efficiency. Key Responsibilities: - Configure, customize, and deploy Veeva Vault QMS modules (QRM, CAPA, Change Control, Complaints) to align with client-specific quality processes and regulatory requirements. - Design workflows, object lifecycles, security roles, and page layouts to support scalable and compli...

Site Name: Bengaluru Luxor North Tower Posted Date: Dec 17 2025 Job Purpose Work with the GBPO to develop a strategy for the end-to-end process for PQR generation across medicines sites, vaccines sites, CMOs, LOCs and central functions. Lead deployment of the new global PQR solutions in the supply chain. Act as SME for MAH activities, ensure compliance and oversight of MAH activities for Trading Partner entities, ensuring compliance with relevant regulations, licenses and authority requirements. Lead the MAH GCC team accountable for generating PQRs. Key Responsibilities: Team Leadership: Manage the TPQ MAH/PQR GCC team accountable for generating PQRs. Develop the capabilities within the GCC ...

Title Head - Microbiology Business Unit SGO Quality Job Grade Senior Manager Location: Mohali Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Job Description Responsible for Oversight and Monitoring of Mi...

The purpose of this position is to provide the essential administrative processes, technical knowledge, and perform the work listed This role has the responsibility to promote Fluors competitiveness within the global marketplace by delivering quality services of unmatched value and technical competence This position serves as an Area Lead or Lead on assigned projects or performs moderately complex engineering assignments, evaluates, selects, and applies standard engineering techniques to a broad set of complex assignments Apply Cost Competitive Execution techniques to develop the most cost-effective total project solution for execution of the discipline engineering work Develop and review sp...

Proziod Analytics is looking for Data Analyst -2 to join our team Roles and Responsibility Design, develop, and implement automated tests for complex software applications. Collaborate with cross-functional teams to identify and prioritize testing requirements. Develop and maintain test automation frameworks and tools. Analyze and report defects found during testing. Participate in agile development methodologies and collaborate with developers to resolve issues. Continuously improve testing processes and procedures. Job Requirements Strong knowledge of automation testing principles and methodologies. Experience with test automation frameworks and tools such as Selenium or Appium. Excellent ...

Job Responsibilities : Inspection of received samples and identifies the in-coming samples and segregates to different groups as per the testing requirementmunicate to shift in charge for abnormal samples or non-receipt of samples Inspection of received finished product samples, distribution of finished product sample to the different sections of the laboratory Analysis of finished product and carry out the complete analysis as per contractual methods and specifications and ensure effective sample management Carry out required tests as per provided standard test methods Detect exceptions or deviations in test results and report to Shift In charge immediately Actions/ communication on re samp...

Sampling and analysis of In-process samples, Intermediates, Hold time samples, Process validation samples, Cleaning validation samples, Rinse samples, Swab samples, Raw materials, Particle size analysis and Finished products by HPLC Analysis of accelerated and long term stability studies of APIs Analysis for qualification of working standards and impurity standards as per requirement Initiation, completion and filing of Daily Analytical Reports Calibration of instruments as per calibration schedule To complete activity of Preventive maintenance of analytical Instruments To initiate the change control and perform related activity Maintenance of HPLC columns Monitoring of stock of adequate gla...

Dishman Carbogen Amcis Ltd is looking for Executive to join our team Roles and Responsibility Manage and oversee daily operations for efficient workflow. Develop and implement strategies to achieve business objectives. Collaborate with cross-functional teams to drive growth and improvement. Analyze market trends and competitor activity to identify opportunities. Build and maintain strong relationships with clients and stakeholders. Identify and mitigate risks to ensure compliance with regulatory requirements. Job Requirements Proven track record of success in a similar role. Strong leadership and management skills with the ability to motivate teams. Excellent communication and interpersonal ...

Reliance Industries Limited is looking for Lab Analyst QA/QC DMD to join our team Roles and Responsibility Conduct laboratory tests and analyze results to ensure compliance with quality standards. Develop and implement quality control procedures to enhance product quality. Collaborate with cross-functional teams to resolve quality-related issues. Maintain accurate records of test results and quality control activities. Identify areas for improvement in quality control processes and recommend changes. Ensure all laboratory operations comply with regulatory requirements. Job Requirements Bachelor's degree in Science (B.Sc) or equivalent. Minimum years of experience in a laboratory setting, pre...

Job Description JOB Responsibilities: - Location: Ahmedabad 1. Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU. 2. Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market. 3. Handling of market complaint with root cause identification and ensuring the CAPA implementation. 4. New product review to be carried out at manufacturing site after availability of all the documents. 5. Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished p...

Job Title :Sr. Executive/Assistant Manager Functional Area : Quality Assurance Key Accountabilities Technical and QMS Documentation: Preparation and Review of Documents as per ISO 13485, EU-MDR, 21CFR820, Thai FDA and Indian Medical Device Rule and ensure implementation of same. Handling of Deviation, Non-Conformance, Change controls and CAPA. Handling of Post market surveillance Preparation of the regulatory documents (TMF/Dossiers) for regulatory submission. Preparation of Technical files in co-ordination with R&D Team. Preparation of Design file as per ISO 13485:2016, MDR and USFDA. Handling of Adverse event reporting to EU and other regulatory body. Familiar to handle Eudamed, Maude and ...

0 Responsibilities: To carry out the following routine checks in the laboratory on daily basis: Responsibility for investigation report writing and closure of deviation, OOS and OOT. Qualification of working standards. Glassware verification & labelling. Routine calibration and verification of all instruments. Logbooks verification. To ensure that the documentation done is online and error free. To ensure the correctness of the document before submitting it for the review of Group Leader/AQA reviewer. Column stock, inventory, indent, requirement and routine usage verification. Reference/Working standard and impurities verification. Area upkeep and maintenance. Calibration schedule/document/l...

Role & responsibilities Deputy Manager - IPQA DS Experience - 10-12yrs 1. Cell bank management 2. Issuance of line clearance 3. Upstream and Downstream batch record review 4. Routine IPQA activities 5. Hands on experience on digital systems such as Trackwise/ Veeva/ SAP/ LMS/ DMS/ E-Val etc. 6. Deviation, OOS, OOT investigation review and approval 7. Change control initiation, review, approval 8. CAPA initiation, review and effectiveness verification 9. Exposure to regulatory audits 10. Risk assessment review and approval 11. Process and cleaning validation 12. APQR preparation and review 13. Periodic Trending of QMS elements 14. Review and approval of environmental monitoring trends 15. Rev...

Ready to shape the future of work At Genpact, we don't just adapt to change - we drive it . AI and digital innovation are redefining industries, and we're leading the charge . Genpact's AI Gigafactory , our industry-first accelerator , is an example of how we're scaling advanced technology solutions to help global enterprises work smarter , grow faster , and transform at scale . From large-scale models to agentic AI, our breakthrough solutions tackle companies most complex challenges . If you thrive in a fast-moving , tech-driven environment , love solving real- world problems , and want to be part of a team that's shaping the future, this is your moment . Genpact (NYSE: G) is an advanced te...

shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc Label artwork review and management Required Candidate profile Assisting HOD in customer complaint analysis and preparation of customer complaint report. Investigation of incidents, deviations, OOS and ensure corrective actions in place.

Lead overall plant operations including Production, QA, QC & Engineering. Ensure cGMP compliance, regulatory readiness, people leadership, cost optimization, EHS adherence, and timely execution of plant expansion and improvement projects. Health insurance Annual bonus Provident fund

Dishman Carbogen Amcis Ltd is looking for Executive API QC to join our team Collaborate with cross-functional teams to achieve strategic outcomes. Apply subject expertise to support operations, planning, and decision-making. Utilize tools, analytics, or platforms relevant to the job domain. Ensure compliance with policies while improving efficiency and outcomes.

Role Profile Reporting to the Director of LSE plc and FX Technology Operational Resilience, this role provides project management support, and project governance and control services to key projects and programmes in the Markets portfolio. Working closely with the Markets Project Managers, Portfolio PMO and Finance, the Project PMO role is responsible for providing all primary PMO services to the Director of LSE plc and FX Technology Operational Resilience, including but not limited to support on project level: Supporting monthly reporting to the Markets Portfolio Boards Supporting adhoc stakeholder updates Risk and Issue management Financial management (management of cost plans and tracking...

Role & responsibilities Quality professional of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement & API Manufacturing, QMS, Qualification, Validation and other Manufacturing functions. Personnel shall have experience to handle certification, customer & regulatory inspection i.e.: IMS, WHO-GMP, FSSC, FAMI-QS, EnMS, Halal, Kosher & Responsible Care & regulatory (FDCA, USFDA, MHRA). Expertise in change control, deviation, market complaint, non-conformance investigation, vendor audit, self-inspection, gap assessment, customer audit, training, vendor management, vendor questionnaire, validation, equipment & utility system qualifi...

Job Description Summary The Program/Project Manager is responsible for ensuring the success of sustaining engineering programs within the Specimen Management (SM) business at BD. Specifically, We are seeking a highly skilled and motivated Hybrid Agile Project/Program Manager to lead a dynamic cross-functional, hybrid agile team focused on addressing a backlog of projects within our blood specimen collection product group. The successful candidate will have a proven track record in hybrid agile project management, cross-functional team leadership, and a deep understanding of highly regulated environments. This role requires the ability to navigate teams through compliance, supply continuity, ...

Role Overview: As a manager, you will lead and direct high-priority, data-driven projects, managing timelines and developing project plans. Your responsibilities will include handling the more technical aspects of reporting and data analysis, requiring coordination across agency departments. You will represent the data analysis team within accounts, manage client expectations, and ensure necessary information is disseminated to team members for efficient project execution. Your depth within accounts will vary based on engagements, with projects ranging from data receipt and preparation to full-blown data reporting development. Key Responsibilities: - Plan and support the design and implement...