Quality Assurance Executive Jobs at Enzene | Chemistry Jobs Pune
Are you looking for a Quality Assurance Executive role or Chemistry Jobs in Pune? This Executive – QA – IPQA position offers strong exposure to in-process quality assurance, GMP compliance, analytical QA, and validation activities in a biopharmaceutical manufacturing setup. It is an excellent opportunity for professionals seeking MSc Chemistry Jobs and long-term growth in quality assurance careers.
About Enzene
ENZBIO operates in the biopharmaceutical sector with a strong focus on regulatory compliance, quality systems, and GMP-driven manufacturing. The organization offers excellent opportunities for Quality Assurance Executives, especially professionals seeking MSc Chemistry Jobs and Chemistry Jobs in Pune, with exposure to advanced QA, IPQA, and quality management systems.
- Position: Executive – QA – IPQA
- Location: Pune, Maharashtra, India
Roles & Responsibilities
IPQA & Manufacturing Oversight
- 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.
Analytical QA & Data Integrity
- Review analytical QC documents and ensure compliance with approved specifications and test procedures.
- Perform audit trail reviews for critical QC instruments and relevant process equipment to ensure data integrity (ALCOA+ compliance).
- Support and manage QA activities using eDMS and other digital quality systems.
Validation & CPV Review
- Review Continued Process Verification (CPV) data and ensure trending and compliance.
- Review Process Validation Protocols and Reports.
- Review Cleaning Validation Protocols and Reports to ensure effectiveness and regulatory compliance.
Deviation, Breakdown & Complaint Handling
- Handle breakdown-related QA activities, including acknowledgement and receipt of complaints from user departments.
- Support investigation, documentation, and closure of quality events related to manufacturing and QC operations.
Documentation & QMS Support
- Prepare, review, approve, and control SOPs and quality documents in line with QMS requirements.
- Ensure timely documentation, version control, and compliance with regulatory expectations.
Qualification: M.Pharm or M.Sc (Chemistry / Biotechnology / Microbiology or related discipline)
Experience: 3 to 6 years of experience in the biopharmaceutical industry
Skills & Competencies
- Strong experience in IPQA activities and analytical document review
- Sound knowledge of cGMP and data integrity principles
- Experience with eDMS / electronic quality systems
- Good understanding of validation, CPV, and batch documentation
