Job Description
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.
What You Will Achieve
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
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
- 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
- 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
- B. Pharm/M. Pharm/M.Sc.
Looking to get Placed? Try our Placement Guarantee Plan
- Masters Degree: 2–3 years
- Bachelors Degree: 4–5 years
- Experience in Pharma / Biotech QA, QC, or Manufacturing
- Change Management process experience
- Risk assessments principles and tools
- Validation of manufacturing equipments
- 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
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Quality Assurance and Control
Skills
Document ReviewInvestigationIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
About Company
Pfizer, a global biopharmaceutical company, pioneers breakthroughs that change patients' lives. With a legacy spanning over 170 years, Pfizer is committed to advancing science and healthcare. Focusing on research, development, and manufacturing, it offers a wide range of medicines, vaccines, and consumer healthcare products. Pfizer's dedication to innovation and collaboration drives its mission to bring therapies to people that significantly improve their lives. Pfizer Careers offers diverse opportunities for professionals worldwide to contribute to transformative healthcare solutions, fostering growth and development in a supportive environment. Join Pfizer in shaping the future of healthcare and making a meaningful impact on global health.
Important dates & deadlines?
Application Deadline
14 Nov 26, 05:35 PM IST
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Associate (Quality Assurance Operations/ Compliance/ Investigations)
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