Associate Manager Quality Assurance
3 days ago
This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.ROLE SUMMARYResponsible for reviewing documents related to product development, analytical data (including electronic data, chromatographic data, and audit trails), as well as instrument and equipment qualificationAccountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and electronic recordsConduct periodic system audit trail reviews and ensure compliance with 21 CFR Part 11 requirementsLiaise effectively with global BL and OQ colleagues to achieve organizational objectivesMaintain a thorough understanding of ICH quality guidelines and relevant regulatory guidance on microbiology method development pertaining to sterility, BET, CCIT, and associated development requirementsPossess in-depth knowledge regarding sterility requirements and filter validation activities in accordance with PDA technical reportsDemonstrate familiarity with requirements for sterile ANDA product development and combination productsExhibit strong proficiency in MS Office applications, including Excel, Word, and PowerPoint presentation preparationROLE RESPONSIBILITIES & SKILL SETSAwareness of DI and ALOCA principlesBasic understanding of cGMP requirements, including 21 CFR part 210 and 211, ICH guidelines, and sterile product requirementsMaintain compliance in laboratories and during document reviewAbility to perform statistical evaluation and analysis of analytical data during method development and validation reviewEffective communication skills.Adherence to discipline and self-motivation.Participate in the implementation of new initiatives and goals within the QA function and with business line partners to support consistency, efficiency, and compliance.Manage time to meet agreed targets and plan work activities for projects within assigned teams.Suggest improvements and participate in continuous improvement activities.Contribute to the development and compliance of quality and business line partner proceduresProvide support for inspection readiness efforts, internal audits, and regulatory inspections as requiredQUALIFICATIONSEducation:Master of science in chemistryMaster of pharmacyRelevant experience:Relevant work experience in an analytical data review and Technology transfer and cGMP pharmaceutical sterile manufacturing areaLocation: On premiseWork Location Assignment: On PremisePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control
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Associate Manager Quality Assurance
5 days ago
Chennai, India Pfizer Full timeROLE SUMMARY Responsible for reviewing documents related to product development, analytical data (including electronic data, chromatographic data, and audit trails), as well as instrument and equipment qualification Accountable for ensuring data integrity compliance and adherence to SOPs during the review of both hard copy and electronic records Conduct...
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