Job Description – QA Manager (Eye Drop & Injection)
Position: QA Manager
Department: Quality Assurance
Industry: Pharmaceutical (Sterile – Eye Drop & Injection)
Qualification
- B.Pharm / M.Pharm / M.Sc. (Chemistry/Microbiology or relevant discipline)
Experience
- 10–15 years of experience in a pharmaceutical sterile manufacturing facility.
- Strong exposure to Eye Drop and Injection manufacturing.
- Experience in regulatory-approved plants (WHO-GMP/USFDA/EU-GMP/MHRA or equivalent) preferred.
Key Responsibilities
- Manage all Quality Assurance activities for sterile Eye Drop and Injection manufacturing.
- Ensure compliance with cGMP, GDP, Data Integrity, and regulatory requirements.
- Review and approve SOPs, BMRs, BPRs, protocols, reports, specifications, and validation documents.
- Handle QMS activities including Deviations, CAPA, Change Control, OOS, OOT, and Risk Assessment.
- Oversee qualification and validation activities (Equipment, Process, Cleaning, HVAC, Water System, Sterilization).
- Ensure aseptic manufacturing practices and environmental monitoring compliance.
- Conduct batch review and batch release in accordance with quality standards.
- Coordinate internal audits, regulatory inspections, and customer audits.
- Lead investigations related to quality issues and implement effective CAPAs.
- Ensure training and development of QA personnel.
- Coordinate with Production, QC, Engineering, Warehouse, and Regulatory Affairs for smooth operations.
- Maintain documentation in compliance with GMP and Data Integrity requirements.
- Drive continuous improvement initiatives to enhance product quality and regulatory compliance.
Required Skills
- Strong knowledge of GMP, GLP, GDP, ICH Guidelines, and Data Integrity.
- Hands-on experience with sterile manufacturing processes.
- Excellent leadership, communication, and team management skills.
- Strong problem-solving and decision-making abilities.
- Proficiency in documentation review and quality systems.
Preferred Candidate: Immediate joiner with strong exposure to Eye Drop and Injection manufacturing.
Ph 09857316116
Pay: ₹80,000.00 - ₹100,000.00 per month
Benefits:
Work Location: In person
