AGM -QA Head
2 weeks ago
                                            
							
							Kandla, India                                        
							
							Rusan Pharma
																					
							Full time                                        
							
														
							₹ 20,00,000 - ₹ 25,00,000 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