Job Title: Associate Manager – Quality Assurance
Company: Pfizer
Location: India – Vizag (On Premise)
Employment Type: Full-Time
Job ID: 4952435
Experience Required: Minimum 8 years in injectable manufacturing and Quality Assurance
About Pfizer
Pfizer Global Supply (PGS) is dedicated to delivering high-quality pharmaceutical products worldwide. Our commitment to patient safety drives every action, ensuring that all operations, from manufacturing to quality oversight, meet rigorous global standards. Joining Pfizer means contributing to a culture that combines innovation, compliance, and patient-focused excellence.
Role Summary
The Associate Manager – Quality Assurance will lead and manage quality assurance activities for injectable manufacturing operations. This role is responsible for change control management, technology transfer oversight, process validation, compliance with GxP regulations, and supporting continuous improvement initiatives to maintain inspection readiness and operational excellence.
Key Responsibilities
Change Control & Quality Risk Management
Manage the full lifecycle of change control processes, including evaluation, approvals, implementation, and effectiveness checks.
Review and approve Quality Risk Assessments to evaluate potential impacts on product quality and compliance.
Ensure changes comply with internal standards, GxP regulations, and industry best practices.
Communicate relevant changes to cross-functional stakeholders, including regulatory affairs, quality, and production teams.
Technology Transfer & Validation Oversight
Review Technology Transfer documents, scale-up protocols, reports, exhibit batch records, and process validation documents for injectable products.
Ensure effective Technology Transfer of injectables, including FAT, SAT, URS, and equipment qualification protocols (IQ/OQ/PQ/PRQ).
Independently assess change control and validation activities for potential quality or operational risks.
Compliance & Quality Assurance
Investigate and document Quality Assurance deviations, escalating issues as needed.
Provide oversight and review of site documentation to ensure compliance with cGMP, GxP regulations, and Pfizer quality standards.
Maintain high standards in documentation, process reviews, and operational execution to support global regulatory readiness.
Collaboration & Continuous Improvement
Work effectively with cross-functional teams to implement and monitor quality initiatives.
Mentor and support junior colleagues in QA processes and compliance activities.
Utilize AI and emerging digital tools, including ChatGPT and Microsoft Copilot, to enhance problem-solving, efficiency, and data analysis while ensuring responsible and ethical AI practices.
Qualifications & Experience
M.Pharm, B.Pharm, or MSc in relevant scientific field.
Minimum 8 years of experience in injectable manufacturing and Quality Assurance.
Solid knowledge of current Good Manufacturing Practices (cGMP) and GxP regulations.
Strong critical thinking, problem-solving, and organizational skills.
Ability to work in three-shift operations (A/B/C).
Proficient in Microsoft Excel, Word, and quality documentation systems.
Preferred Qualifications
Experience with quality administration systems.
Proven ability to review and mentor colleagues.
Familiarity with regulatory compliance, documentation, and inspection readiness processes.
Experience using AI tools to support productivity and compliance activities.
Why Join Pfizer?
This role offers the opportunity to directly influence patient safety by ensuring quality compliance in injectable manufacturing operations. You will lead initiatives that uphold Pfizer’s commitment to excellence, support global regulatory standards, and contribute to a culture of continuous improvement and inspection readiness.
Work Location: On Premise – Vizag, India
Pfizer is an equal opportunity employer and adheres to all applicable employment legislation in each jurisdiction where it operates.
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