Assistant Manager – IPQA (DS)
Location: Pune, Maharashtra, India | Employee Type: Permanent | Department: Quality Assurance
Company Overview:
Join a leading biopharmaceutical organization specializing in drug substance (DS) development and manufacturing. The IPQA team ensures compliance with CGMP, drives quality investigations, and maintains robust documentation to support process validation and operational excellence.
Role Overview:
We are seeking an Assistant Manager – IPQA (DS) with strong expertise in quality assurance operations, documentation management, and team leadership. The role involves oversight of documentation, batch investigations, process validation review, and continuous improvement initiatives.
Key Responsibilities:
Documentation Management: Prepare, review, and manage Change Control, Deviation, Out of Specification (OOS), CAPA, Lab Incident, and APQR documentation; ensure timely follow-up and closure.
Cell Bank & Technology Transfer: Manage and review Cell Bank documents and Technology Transfer documentation.
Validation Oversight: Review Process Validation protocols and reports, Cleaning Validation protocols and reports, and batch manufacturing records.
Continuous Process Verification: Review CPV data and PQR using JMP software.
Shop Floor Investigations: Conduct investigations on IPQA shop floors to ensure compliance and quality.
Audit & Compliance: Execute and monitor internal audit programs to maintain CGMP compliance.
Team Management: Lead and manage the QA team, ensuring engagement, productivity, and adherence to quality standards.
Technical Skills Required:
Strong knowledge of IPQA operations, CGMP, and documentation standards.
Proficiency with JMP software for CPV and PQR data analysis.
Hands-on experience with process and cleaning validation review.
Qualifications & Experience:
Bachelor’s or Master’s degree in Pharmacy, Biotechnology, or related field.
8–11 years of relevant experience in IPQA/QC/QA within the pharmaceutical or biopharmaceutical industry.
Soft Skills:
Strong leadership and team management skills.
Excellent analytical, organizational, and problem-solving abilities.
Effective communication and cross-functional collaboration skills.
Why Join Us:
This position offers exposure to advanced quality assurance operations, leadership opportunities, and the chance to contribute to CGMP-compliant manufacturing and process excellence in a dynamic environment.
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