Officer QA – Antisera Industry
Department: Quality Assurance (QA)
Designation: QA Executive
Reports To: QA Manager / Head – Quality Assurance
Job Purpose:
To ensure that antisera manufacturing activities are performed in compliance with cGMP, GLP, GDP, and applicable regulatory requirements while maintaining product quality, data integrity, and audit readiness. QA Executives in biologics and antiserum manufacturing typically oversee documentation, in-process quality activities, validation support, CAPA, deviations, and audit compliance.
Qualification Activity of equipment systems and instruments.
Key Responsibilities
- Ensure compliance with cGMP, GLP, GDP, and company SOPs.
- Review and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
- Perform line clearance before manufacturing and packaging activities.
- Conduct in-process quality assurance (IPQA) checks during production.
- Prepare, review, and control SOPs, protocols, and quality documents.
- Handle deviations, change controls, CAPA, and investigations.
- Review validation documents (Process Validation, Cleaning Validation, Equipment Qualification).
- Monitor environmental conditions and hygiene compliance.
- Ensure proper documentation practices and data integrity (ALCOA+).
- Coordinate internal, vendor, and regulatory audits.
- Train employees on GMP, SOPs, and quality systems.
- Ensure timely closure of quality events and audit observations.
- Support product release activities as per QA procedures.
Educational Qualification
- M.Sc. (Microbiology / Biotechnology / Biochemistry / Life Sciences) or
- M.Pharm/B Pharm qualification.
Experience
- 2–5 years of experience in QA within the pharmaceutical, vaccine, biologics, or antiserum industry.
- Knowledge of GMP documentation, IPQA, validation, and regulatory requirements is preferred.
Required Skills
- Good Documentation Practices (GDP)
- cGMP and GLP knowledge
- Data Integrity (ALCOA+)
- SOP preparation and review
- Audit handling
- CAPA and Deviation Management
- Validation and Qualification
- Strong communication and analytical skills
- MS Office proficiency
Key Performance Indicators (KPIs)
- Timely review of QA documents.
- Zero critical GMP observations.
- On-time closure of deviations and CAPA.
- Successful internal and external audits.
- Compliance with documentation timelines.
Training completion and effectiveness.
Pay: ₹15,000.00 - ₹30,000.00 per month
Benefits:
- Flexible schedule
- Food provided
- Paid sick time
- Provident Fund
Work Location: In person
