Executive – QA (IPQA)
Location: Pune, Maharashtra, India | Employee Type: Permanent | Department: Quality Assurance
Company Overview:
Join a leading biopharmaceutical organization dedicated to developing and manufacturing high-quality therapeutic products. Our Quality Assurance team ensures compliance, data integrity, and process excellence across manufacturing and analytical operations.
Role Overview:
We are looking for a QA Executive (IPQA) with strong hands-on experience in in-process quality assurance, analytical document review, and batch oversight. The role focuses on ensuring compliance with cGMP, supporting manufacturing operations, and maintaining robust quality management systems.
Key Responsibilities:
IPQA & Manufacturing Oversight
Perform line clearance for new batches, raw material dispensing, cell bank issuance, and Drug Substance (DS) handling.
Provide in-process QA oversight during manufacturing to ensure compliance with approved procedures and GMP.
Review and approve Batch Manufacturing Records (BMRs) and other batch documentation for accuracy, completeness, and compliance.
Analytical QA & Data Integrity
Review analytical QC documents and ensure adherence to approved specifications and test procedures.
Conduct audit trail reviews for critical QC instruments and process equipment to ensure ALCOA+ data integrity compliance.
Support QA activities using eDMS and other electronic quality systems.
Validation & CPV Review
Review Continued Process Verification (CPV) data for trending and compliance.
Review Process Validation and Cleaning Validation Protocols and Reports to ensure regulatory compliance and effectiveness.
Deviation, Breakdown & Complaint Handling
Manage breakdown-related QA activities and handle complaints from user departments.
Support investigation, documentation, and closure of quality events in manufacturing and QC operations.
Documentation & QMS Support
Prepare, review, approve, and maintain SOPs and other quality documents in line with QMS requirements.
Ensure timely documentation, version control, and compliance with regulatory standards.
Qualifications & Experience:
M.Pharm or M.Sc in Chemistry, Biotechnology, Microbiology, or related discipline.
3–6 years of experience in the biopharmaceutical industry, with strong exposure to IPQA and analytical QA activities.
Skills & Competencies:
Sound knowledge of cGMP, data integrity, and IPQA operations.
Experience with eDMS or electronic quality systems.
Understanding of validation, CPV, and batch documentation review.
Strong attention to detail, analytical mindset, and effective communication skills.
Why Join Us:
This role provides an opportunity to work in a high-quality biopharmaceutical environment, gain exposure to end-to-end QA processes, and contribute to maintaining regulatory compliance and operational excellence.
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