Associate – Quality Assurance (Operations / Compliance / Investigations)
Company: Pfizer
Location: Visakhapatnam (Vizag), Andhra Pradesh, India
Employment Type: Full-Time
Department: Quality Assurance & Quality Control
Job ID: 4956953
About Pfizer
Pfizer is one of the world's leading biopharmaceutical companies dedicated to discovering, developing, and delivering innovative medicines and vaccines that improve patient lives globally. At Pfizer, colleagues work together to make a meaningful impact on healthcare while maintaining the highest standards of quality, compliance, and patient safety.
Position Summary
Pfizer is seeking a highly motivated Associate – Quality Assurance (Operations, Compliance & Investigations) to support quality operations within a regulated pharmaceutical manufacturing environment. The role is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, quality systems, and internal procedures through document review, shop-floor quality oversight, deviation management, compliance monitoring, and investigation support.
The ideal candidate should possess strong knowledge of pharmaceutical manufacturing processes, quality systems, documentation practices, and regulatory compliance requirements.
Key Responsibilities
Quality Operations
Review batch manufacturing records, batch documentation, and Quality Control records (BQ/CQ).
Perform documentation review to ensure compliance with Good Documentation Practices (GDP).
Provide shop-floor Quality Assurance support during manufacturing and packaging activities.
Conduct in-process quality checks and GMP compliance monitoring.
Review and approve:
Standard Operating Procedures (SOPs)
Specifications
Standard Test Procedures (STPs)
Study Protocols
Support batch release documentation review activities.
Quality Compliance
Support internal audits, customer audits, and regulatory inspections.
Participate in inspection readiness activities and regulatory commitment tracking.
Ensure compliance with:
cGMP requirements
GDP requirements
Global regulatory guidelines
Internal quality standards
Support quality systems including:
Change Control
CAPA Management
Document Control
Data Integrity Programs
Assist in maintaining quality records and documentation systems.
Quality Investigations
Support deviation investigations and quality event management.
Participate in root cause analysis activities using structured investigation methodologies.
Assist in implementation and effectiveness tracking of CAPA actions.
Monitor investigation timelines and closure commitments.
Ensure complete and accurate investigation documentation.
Required Qualifications
Education
Bachelor's Degree
B.Pharm
M.Sc. (Relevant Life Science Discipline)
Master's Degree
M.Pharm
M.Sc. (Relevant Life Science Discipline)
Experience Requirements
For Bachelor's Degree Holders
4–5 years of experience in:
Quality Assurance
Quality Control
Pharmaceutical Manufacturing
For Master's Degree Holders
2–3 years of experience in:
Quality Assurance
Quality Control
Pharmaceutical Manufacturing
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