Owner at Career Advantage Human Resources & Services
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Head - Quality Assurance & Regulatory Affairs - Pharma (15-18 yrs)
Reporting will be to Plant Head/CEO
Experience : 15+ years approx. with good experience in reputed Pharma companies and working in plants with USFDA and/or EU GMP certification
Qualification : M.Sc. Industrial Chemistry/ Ph.D Chemistry
Key Job responsibilities :
1. Ensuring complete quality compliance of the organization to cGMP/QMS/FSMS/HACCP/ISO, EU GMP and other quality management systems. This includes responsibility for preparation, upgradation and maintenance of documentation and SOP's for the same, implementation of the system with coordination of all departments, performing of internal audits and follow up with corrective action etc.
2. Preparation of Drug Master Files, CTD and COS documents for all products as per regulatory requirements.
3. Responsibility for monitoring all quality aspects of the plant, dealing with quality problems and complaints, participating, review and implementation of corrective actions during product quality complaints and product recall operations.
Job Description :
1. Training to all departments on all aspects of quality, and quality related systems
2. Liaison with state and central drug authorities for licences for plant and all products
3. Responsible for all regulatory agency inspections and approvals and all customer and third-party audits
4. Supervision of EHS related work - setting up systems related to EHS activities and training on various aspects
1. Systems and process orientation
2. Very strong on ethics and values
3. Good people management skills
4. Very good planning and coordination capabilities
5. Effective communication skills
6. Detail oriented
7. Energetic, dynamic person who can be groomed to take on a larger EHS leadership role and business process improvement role and serve as a member of the core leadership team