
AGM -QA Head
22 hours ago
Kandla, India
Rusan Pharma
Full time
₹ 15,00,000 - ₹ 28,00,000 per year
Key Responsibilities
- Lead and manage the Quality Assurance department, ensuring compliance with GMP norms and regulatory requirements of WHO, EU GMP, PICS, TGA, MHRA, USFDA, and other global agencies.
- Develop, implement, and monitor Quality Management Systems (QMS) across all QA functions.
- Ensure strict adherence to SOPs and continuous improvement practices in line with regulatory expectations.
- Oversee handling of rejected materials, market complaints, product recalls, deviations, change controls, CAPA, and CCF.
- Manage end-to-end Validation and Qualification activities (process validation, cleaning validation, equipment qualification, analytical method validation, etc.).
- Ensure audit readiness at all times and lead regulatory/customer audits and inspections.
- Review, approve, and monitor the control of documents, records, and quality risk management systems.
- Provide leadership and guidance to QA teams, including training, mentoring, and performance monitoring.
- Collaborate with cross-functional teams (Production, QC, R&D, Regulatory Affairs) to maintain high-quality standards.
- Drive initiatives for continuous quality improvement and compliance to ensure products meet global regulatory expectations.
Desired Candidate Profile
- B.Pharm / M.Pharm with 1520 years of proven experience in Quality Assurance of Pharma Formulation Units.
- Strong command over WHO GMP, EU GMP, PICS, TGA, MHRA, and USFDA regulatory guidelines.
- Expertise in handling market complaints, investigations, and product recalls.
- Thorough knowledge of CAPA, deviations, and change control processes.
- In-depth experience in validation & qualification activities.
- Excellent leadership, decision-making, and cross-functional coordination skills.
- Strong communication skills with the ability to face regulatory and customer audits confidently.
- Willingness to relocate to Gandhidham.
- Candidates who can join immediately will be given preference.
Compensation & Benefits
- Competitive salary aligned with industry standards.
- Relocation support for suitable candidates.
- Opportunity to head the QA function and drive strategic quality initiatives for a regulated market facility.Role & responsibilities