Job Title: Sr. Executive - Quality Compliance (Supplier Quality Assurance)
Department: Quality Compliance
Reports to: Quality Compliance Manager
Location: Ankleshwar
Position Type: Full time

Qualifications and Experience:
- Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.
- Experience: Minimum 6–8 years of experience in Quality Assurance / Quality Compliance within the pharmaceutical industry, with at least 2 years in a Supplier Quality Assurance role.
- Preferred: Exposure to regulatory inspections (e.g., USFDA, MHRA, TGA), and experience in working with global suppliers.

Job Purpose:
To lead and manage Supplier Quality Assurance (SQA) activities ensuring all third-party suppliers, vendors, and contract manufacturers comply with applicable regulatory requirements, company quality standards, and Good Manufacturing Practices (GMP). The role involves oversight of supplier qualification, audits, risk assessment, and continuous quality improvement initiatives within the pharmaceutical supply chain.

Key Responsibilities:




Supplier Quality Management:
- Develop, implement, and maintain a robust supplier quality assurance system aligned with cGMP and regulatory requirements (e.g., USFDA, EMA, WHO).
- Lead supplier qualification, requalification, and performance monitoring programs.
- Conduct risk-based assessments and ensure supplier categorization based on product and service criticality.

Auditing & Compliance:
- Plan, conduct, and follow up on supplier audits (on-site and remote) for API, excipient, packaging, and service providers.
- Evaluate audit findings, identify gaps, and oversee closure of CAPAs with suppliers.
- Maintain audit schedules, records, and ensure timely reporting.
- Maintenance of Approved Supplier List / GMP documents / Supplier files

Quality Agreements & Documentation:
- Coordinate the drafting, negotiation, and maintenance of Quality Agreements with suppliers.
- Review supplier documentation such as CoAs, TSE/BS

📌 Senior Executive (Ankleshwar)
🏢 Zentiva Group
📍 Ankleshwar