Job Description
Responsible for independent management, review, and approval of Quality Assurance activities. Ensures implementation of quality systems, drives regulatory compliance, leads investigations, and collaborates with cross-functional teams to maintain cGMP standards and inspection readiness.
What You Will Achieve
Role Responsibilities:
- Strong knowledge of manufacturing processes, quality control, and validation activities (process, cleaning, analytical methods, equipment, utilities)
- Advanced technical document review and approval capability
- Expertise in change control and risk assessment
- Strong knowledge of chemical and microbiological testing
- Knowledge of investigations tools and root cause analysis methodologies
- Understanding of manufacturing operations, engineering, and validation systems
- Experience in handling regulatory inspections
- Accountability: Self-driven, proactive, and responsible for quality outcomes
- Critical thinking and strong compliance mindset
- Strong time management and problem-solving abilities
- Interpersonal Skills: Builds strong cross-functional relationships and communicates effectively across all organizational levels
- Decision Making: Makes timely, independent, and risk-based quality decisions
- Leadership Skills: Provides guidance, coaching, and technical direction to team members
Quality Operations
- Review and approve QC documents (BQ, CQ), batch records, validation protocols, and reports
- Review and approve SOPs, specifications, STPs, and study protocols
- Review stability reports, APRs, and trend reports
- Ensure manufacturing quality compliance and adherence to procedures
- Participate in Site Change Review Committee (SCRC) and assess critical changes
- Provide quality oversight for manufacturing and laboratory operations
- Ensure implementation and effectiveness of Quality Management Systems (Change Control, CAPA, Deviations)
- Lead audit and inspection readiness activities (internal, regulatory, corporate)
- Interface with regulatory agencies and support inspections (USFDA, MHRA, etc.)
- Ensure compliance with cGMP, GDP, and global regulatory requirements
- Drive quality culture and continuous compliance improvements
- Review and approve quality system documentation and risk assessments
- Lead, review, and approve deviation investigations and CAPA
- Ensure robust root cause analysis and effective corrective/preventive actions
- Drive timely closure of investigations and escalation of critical issues
- Utilize advanced investigation tools and methodologies
- Ensure investigation quality meets regulatory expectations
- Provide technical guidance and mentoring to junior team members
- Coordinate with cross-functional teams for resolution of quality issues
- Present critical quality decisions to leadership
- Identify process improvement opportunities and drive efficiency initiatives
- Ensure timely closure of action items and commitments
- Report and escalate critical non-compliance issues
Looking to get Placed? Try our Placement Guarantee Plan
- B. Pharm/M. Pharm/M.Sc.
- Masters Degree: 4 – 5 years
- Bachelors Degree: 6 – 8 years of experience in Pharma / Biotech Quality Assurance / Quality Control / Compliance / Investigations of sterile dosage manufacturing facility
- Change Management process
- Risk assessments principles and tools
- Validation of lab equipments
- Drug Product Process validations
- Regulatory requirements
- Compendial Changes
- Knowledge on Regulatory Guidelines, Good documentation practices and good manufacturing practices.
- Adhering to Site Procedures and corporate polices
- 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
AuditAssuranceCapaCgmpChange ControlChange Management ProcessDocument ReviewInvestigationManufacturing QualityMhraQcQuality OperationsQuality SystemsProcess ImprovementQuality AssuranceQuality ControlQuality ManagementSopsRoot Cause AnalysisIf 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, 01:44 PM IST
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Associate Manager (Quality Assurance Operations/ Compliance/ Investigations)
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