Quality Assurance Job at Pfizer | Apply Now for the Associate Manager Role
Pfizer is seeking an Associate Manager Quality Assurance for its facility in Chennai, India. This “On Premise” Quality Assurance Job is designed for professionals with a Master’s in Pharmacy or Chemistry who have significant experience in analytical data review and sterile manufacturing. The Associate Manager will be responsible for ensuring Data Integrity (ALCOA+) compliance, conducting 21 CFR Part 11 audit trail reviews, and overseeing filter validation activities in accordance with PDA technical reports. This is a pivotal role for maintaining inspection readiness and supporting sterile ANDA product development.
- Position: Associate Manager Quality Assurance
- Location: India – Chennai
- Job Requisition ID: 4939724
About The Pfizer Job
- 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 periodic system audit trail reviews and ensure compliance with 21 CFR Part 11 requirements
- Liaise effectively with global BL and OQ colleagues to achieve organizational objectives
- Maintain a thorough understanding of ICH quality guidelines and relevant regulatory guidance on microbiology method development pertaining to sterility, BET, CCIT, and associated development requirements
- Possess in-depth knowledge regarding sterility requirements and filter validation activities in accordance with PDA technical reports
- Demonstrate familiarity with requirements for sterile ANDA product development and combination products
- Exhibit strong proficiency in MS Office applications, including Excel, Word, and PowerPoint presentation preparation
Responsibilities and Skills for the Quality Assurance Job
- Awareness of DI and ALOCA principles
- Basic understanding of cGMP requirements, including 21 CFR parts 210 and 211, ICH guidelines, and sterile product requirements
- Maintain compliance in laboratories and during document review
- Ability to perform statistical evaluation and analysis of analytical data during method development and validation review
- Effective 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 procedures
- Provide support for inspection readiness efforts, internal audits, and regulatory inspections as required
Qualifications
- Education
- Master of Pharmacy
- Relevant experience: Relevant work experience in an analytical data review, technology transfer, and cGMP pharmaceutical sterile manufacturing area
