Assistant Manager – IPQA (Drug Substance)
Location: Pune, Maharashtra, India
Employment Type: Permanent
Department: Quality Assurance – U2
Industry: Biopharmaceutical / Biotechnology
Job Overview
We are seeking an experienced Assistant Manager – IPQA (Drug Substance) to support and strengthen in-process quality assurance activities across manufacturing operations. The role is responsible for ensuring cGMP compliance, effective quality systems management, validation oversight, CPV review, and cross-functional QA leadership within a regulated biopharmaceutical environment.
This position plays a critical role in maintaining product quality, data integrity, and inspection readiness throughout the drug substance lifecycle.
Key Responsibilities
IPQA & Shop Floor Oversight
Perform in-process QA oversight and investigations on manufacturing shop floors for Drug Substance operations.
Ensure compliance with approved procedures, batch records, and GMP requirements.
Documentation & QMS Management
Prepare, review, and manage quality documentation including Change Control, Deviations, OOS, CAPA, Lab Incidents, APQR, and investigation reports.
Ensure timely follow-up, closure, and effectiveness verification of all QMS actions.
Validation & CPV Review
Review and approve Process Validation and Cleaning Validation protocols and reports.
Review Continued Process Verification (CPV) data and ensure appropriate trending and compliance.
Utilize JMP software for CPV and PQR analysis and reporting.
Technology Transfer & Cell Bank Documentation
Handle and review Cell Bank documentation and Technology Transfer (TT) documents.
Ensure completeness, accuracy, and regulatory compliance of transferred knowledge and data.
Internal Audits & Compliance
Execute and monitor internal audit programs to ensure continuous GMP compliance.
Support inspection readiness and regulatory audit preparedness.
Team & Stakeholder Management
Manage QA team engagements and provide guidance on IPQA activities.
Collaborate with Manufacturing, Validation, QC, and other cross-functional teams to resolve quality issues effectively.
Education & Experience Requirements
Educational Qualification: M.Pharm, M.Sc, or equivalent degree in Life Sciences, Biotechnology, Microbiology, or related discipline.
Experience Required: 8–11 years of relevant experience in IPQA / Quality Assurance within a biopharmaceutical or pharmaceutical manufacturing environment, with strong exposure to Drug Substance operations.
Key Skills & Competencies
Strong knowledge of cGMP, QMS, validation, CPV, and data integrity principles.
Hands-on experience with JMP software for CPV and PQR.
Proven ability to manage investigations, CAPAs, and complex quality documentation.
Leadership and team coordination skills within QA operations.
Strong analytical, communication, and decision-making abilities.
Why Join This Role
This position offers a strategic opportunity to lead critical IPQA activities, contribute to robust quality systems, and work in a regulated biopharmaceutical environment focused on compliance, innovation, and operational excellence.
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