Assistant Manager - IPQA (DS)

Enzene

9 - 12 years

5 - 11 Lacs

pune

Posted:1 month ago| Platform:

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Skills Required

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Quality Documentation & Compliance:

Document Management:
Management and handling of Cell Bank documentation and Technology Transfer documents to support regulatory and operational compliance.
Validation & Review Activities:
Review of Process Validation and Cleaning Validation protocols and reports, Batch Manufacturing Records (BMR), and Continued Process Verification (CPV) data to ensure accuracy and alignment with regulatory expectations.
CPV & PQR Analysis:
Handling of JMP software for statistical analysis and reporting of CPV and Product Quality Review (PQR) data.
Internal Audits & GMP Compliance:
Execution and monitoring of Internal Audit programs to uphold Good Manufacturing Practices (GMP) and drive continuous quality improvement across the organization.
IPQA & Shop Floor Oversight:
In-process Quality Assurance (IPQA) oversight including shop floor investigations to ensure compliance during manufacturing operations.
Team & QA Engagement Management:
Coordination and management of QA team activities, ensuring effective execution of quality systems and engagement in cross-functional initiatives

Preferred candidate profile

Experience - Between 9 to 12 years

Qualification - M.Sc or M.Pharm

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