Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Associate (Quality Assurance – Operations/ Compliance/ Investigations)
Power for Purpose
Responsible for execution and review support of Quality Assurance (Operations/ Compliance/ Investigations) activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements.
Roles Responsibilities
• Fundamental knowledge of manufacturing and quality control processes (solution preparation, filling, sterilization, visual inspection, packaging)
• Document review and Good Documentation Practices
• Basic knowledge of change control and risk assessment
• Knowledge of chemical and microbiology testing
• Interpersonal Skills: Effective communication with all staff from different levels; builds constructive and effective relationships
• Acts Decisively: Makes decisions in a timely manner based on available information
• Grows Self: Identifies individual development needs and works towards achieving those objectives
• Critical thinking and compliance mindset
• Ability to work in cross-functional teams
Core Responsibilities
Quality Operations
• Review QC documents (BQ, CQ), batch records, and related documents
• Support shop-floor QA activities including GMP compliance monitoring and process checks
• Perform in-process checks and support batch documentation review
• Review SOPs, specifications, STPs, and study protocols
Quality Compliance
• Support audit activities, inspection readiness, and regulatory commitments
• Ensure adherence to cGMP, GDP, and regulatory requirements
• Support quality systems such as Change Control, CAPA tracking, and document management
• Assist in data integrity and documentation control activities
Quality Investigations
• Support deviation investigations and CAPA implementation
• Assist in root cause analysis using investigation tools
• Track investigation closure within timelines
• Ensure proper documentation of investigation records
Candidate Profile
• B. Pharm/M. Pharm/M.Sc.
• Master’s Degree: 2–3 years
• Bachelor’s Degree: 4–5 years
• Experience in Pharma / Biotech QA, QC, or Manufacturing
• Change Management process experience
• Risk assessments principles and tools
• Validation of manufacturing equipment’s
• Drug Product Process validations
• Regulatory requirements
• Compendial Changes
• Knowledge on Regulatory Guidelines, Good documentation practices and Good Manufacturing Practices.
• Thorough understanding of 21CFR 211, Pfizer Quality Standards, site procedures and Processes
• Strong Interpersonal skills
• Ability to communicate effectively with all levels within the organization.
• Compliance driven approach, knowledge on cGMP and regulations.
• Should face national and international inspections such as USFDA, MHRA, TGA & WHO
Additional Information
Experience : B.Pharm / M.Pharm / M.Sc
Qualification : 2-5 years
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance – Operations/ Compliance/ Investigations
End Date : 31st July 2026
Quality Assurance Associate : Apply Online
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