Executive – QA Job At Enzene Biosciences
The Executive – QA – IPQA role at Enzene in Pune offers a strong career opportunity for quality professionals in the biopharmaceutical industry. This Executive Job position focuses on in-process quality assurance, GMP compliance, analytical QA, validation review, and QMS documentation, supporting high-quality manufacturing operations in a regulated environment. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Executive – QA – IPQA
- Location: Pune, Maharashtra, India
About the Company
Enzene is a biopharmaceutical company committed to delivering high-quality biologics through robust manufacturing, compliance-driven quality systems, and continuous improvement. The organization emphasizes regulatory excellence, data integrity, and patient safety across its operations.
Educational Requirements for an Executive Job
-
M. Pharm
Key Responsibilities for an Executive Job
- Perform line clearance activities for new batches, dispensing of raw materials, cell bank issuance, and handling of Drug Substance (DS).
- Provide in-process QA oversight during manufacturing operations to ensure compliance with approved procedures and GMP requirements.
- Review and approve batch manufacturing records (BMRs) and batch documentation for completeness, accuracy, and compliance.
- Review analytical QC documents and ensure compliance with approved specifications and test procedures.
- Performing audit trail reviews for critical QC instruments and relevant process equipment to ensure data integrity (ALCOA+ compliance) is required for this Executive Job role.
- Support and manage QA activities using eDMS and other digital quality systems.
- Review Continued Process Verification (CPV) data and ensure trending and compliance.
- Review Process Validation and Cleaning Validation Protocols and Reports.
- Handle breakdown-related QA activities, including complaints from user departments.
- Support investigation, documentation, and closure of quality events related to manufacturing and QC operations.
- Prepare, review, approve, and control SOPs and quality documents in line with QMS requirements.
Skills Required for an Executive Job
- Strong experience in IPQA activities and analytical document review
- Sound knowledge of cGMP and data integrity principles
- Experience with eDMS and electronic quality systems
- Good understanding of validation, CPV, and batch documentation
Why This Job Role?
This Executive Job role provides hands-on exposure to core QA and IPQA operations within a biopharmaceutical manufacturing environment, offering strong learning opportunities, regulatory exposure, and career growth in quality assurance at Enzene. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
