Quality Assurance Job at Enzene Biosciences
Are you searching for a rewarding Quality Assurance Job in the biopharmaceutical industry? This exciting opportunity at Enzene Biosciences Ltd offers a dynamic role for experienced professionals as an IPQA Executive. If you are looking for an opportunity for life science graduates to work in GMP-regulated environments and gain industry exposure, this role is your gateway to a thriving QA career.
About Enzene Biosciences Ltd Careers
Enzene Biosciences Ltd is a leading biotechnology company specializing in innovative biopharmaceutical solutions. Known for its strong R&D and manufacturing capabilities, the company provides world-class facilities and growth opportunities. Enzene Biosciences Ltd Careers offers an excellent opportunity for life science graduates to work in cutting-edge environments and contribute to global healthcare advancements.
Job Details:
- Job Title: Executive – IPQA
- Job ID: 169
- Location: Pune, Maharashtra, India
- Department: Quality Assurance U2
- Employment Type: Permanent (ENZBIO)
- Experience Required: 3 – 5 Years
Role Overview
The Executive – IPQA is responsible for ensuring quality assurance oversight during manufacturing and analytical processes within a biopharmaceutical environment. The role focuses on maintaining compliance with cGMP standards, ensuring data integrity, and supporting validation and quality management systems.
Key Responsibilities
IPQA & Manufacturing Oversight
- Perform line clearance for new batches, including dispensing of raw materials, cell bank issuance, and Drug Substance (DS) handling
- Provide in-process QA oversight during manufacturing operations to ensure adherence to approved procedures and GMP requirements
- Review and approve Batch Manufacturing Records (BMRs) and related documentation for accuracy, completeness, and compliance
Analytical QA & Data Integrity
- Review analytical QC documents to ensure compliance with approved specifications and test methods
- Conduct audit trail reviews for critical QC instruments and process equipment to ensure ALCOA+ data integrity compliance
- Support QA operations through eDMS and other electronic quality systems
Validation & CPV Review
- Review Continued Process Verification (CPV) data to ensure proper 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
- Manage QA activities related to breakdowns and acknowledge complaints from user departments
- Support investigations, documentation, and closure of quality events related to manufacturing and QC
Documentation & QMS Support
- Prepare, review, approve, and manage SOPs and quality documents in alignment with QMS requirements
- Ensure proper documentation practices, version control, and regulatory compliance
Candidate Profile
The ideal candidate is detail-oriented with strong expertise in quality assurance processes, documentation, and regulatory compliance within a biopharmaceutical setting.
Educational Qualification
- M.Sc in Biotechnology, Microbiology, or a related discipline
Experience
- 2 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 (ALCOA+)
- Experience with eDMS or electronic quality management systems
- Good understanding of validation processes, CPV, and batch documentation
