Department: Quality Assurance (QA)
Experience: 12–15 Years
Qualification: B.Pharm / M.Pharm / M.Sc.
Location: Dombivli, Thane, Maharashtra

The Company is a pharmaceutical manufacturing company engaged in the manufacturing and supply of Active Pharmaceutical Ingredients (APIs) for domestic and international markets. The company is committed to maintaining high-quality standards, regulatory compliance, customer satisfaction, and continuous improvement.

We are looking for an experienced QA Manager with a strong background in pharmaceutical API manufacturing to lead and manage the Quality Assurance function.

Key Responsibilities

- Manage and oversee the overall Quality Assurance function in API manufacturing.
- Ensure compliance with cGMP, cGMP guidelines, SOPs, and Quality Management Systems (QMS).
- Handle deviations, CAPA, change controls, and quality-related investigations.
- Review and approve Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and product specifications.
- Ensure proper batch release and compliance with quality standards.
- Oversee process validation, cleaning validation,



and other quality validation activities.
- Prepare for and manage regulatory inspections and audits.
- Ensure compliance with WHO-GMP and other applicable regulatory requirements.
- Develop, train, and lead the QA team.
- Drive continuous improvement in quality processes and systems.

Required Skills & Experience

- 12–15 years of experience in Pharmaceutical Quality Assurance.
- Mandatory experience in API manufacturing.
- Solid hands-on experience in cGMP and QMS.
- Good knowledge of SOPs, deviations, CAPA, and change control.
- Experience in handling regulatory audits and inspections, preferably WHO-GMP.
- Strong leadership, team management, and decision-making skills.
- Excellent knowledge of pharmaceutical quality and regulatory compliance.

Candidate Profile

Candidates with strong experience in Quality Assurance within API manufacturing companies and proven team leadership capabilities are preferred.

WhatsApp Your CV 85 910 30730

Pay: ₹150,000.00 - ₹167,000.00 per month

Work Location: In person

📌 QA Manager – Pharmaceutical (API Manufacturing) (Dombivli)
🏢 Nelson Infotech
📍 Dombivli