Quality Assurance Jobs at Pfizer | Chemistry Graduates Apply
Are you looking for Quality Assurance Jobs in the pharmaceutical industry? An exciting opportunity is available for experienced professionals in Quality Assurance and Control at a leading global organization. This role is ideal for candidates with strong expertise in analytical data review, cGMP compliance, and sterile product development who want to advance their careers in QA/QC.
- Location India – Chennai
- Time Type Full-time
- Job Requisition ID 4939724
About Pfizer
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. The organization is globally recognized for its commitment to quality, compliance, and innovation within the pharmaceutical industry.
Role 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 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 about 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.Role Responsibilities & Skill Sets
- 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 implementing new initiatives and goals within the QA function and with business line partners to support consistency, efficiency, and compliance.
- Manage time to meet agreed-upon targets and plan project work activities for 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 science in chemistry
- Master of Pharmacy
Relevant Experience
Relevant work experience in an analytical data review, technology transfer, and cGMP pharmaceutical sterile manufacturing area
Location
On premise
