||Job Description and Candidate Profile
||M.Sc / M.Pharm with 20-25 years of experience and around10 years in Managerial position
1. Responsible for Auditing and certifying the new Loan Licensing locations. Various locations
2. Product documentation and its control as per current CGMP norms, at various locations
3. Periodic auditing of existing facilities and controlling of the quality through integrated network
4. Periodic quality review of the existing products
5. Physical & chemical testing of products to ensure product quality
6. Training of technical persons
7. Develop and implement Quality SOP
8. Develop / Refine detailed product specifications in line with new Pharmacopiel guidelines
||VP-Regulatory Affairs cum QA
||P.hd candiates with 20-25 yrs of experience in Pharma Regulatory Affairs cum QA. Minimum 10years experience in Managerial position. Hardcore experience of handling QA Audits and Inspections on his own is a must. Should have well-travelled abroad with regards to profession. Age should be 50yrs and above.
||1. Product dossier preparation in current formats like eCTD for various countries and handling their technical queries, complaints etc.
2. Participation in project teams, performing scientific and technical review on development and regulatory documentation
3. Monitor the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay
4. Ensure adherence to schedule for maintenance of approvals, including supplements to existing approvals
5. Assess and review documentation to ensure compliance with product licences
6. Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance
7. Assign project work and review workload for all direct reports
8. Assist staff with their responsibilities establishing goals that will increase their knowledge and skills level
9. Responsible for Periodic auditing of existing facilities and controlling of the quality through integrated network
10. Responsible for Periodic quality review of the existing products
11. Overall responsible for streamlining and smooth functioning of QA for the organisation including the various locations
|RA & QA
||B.Pharma with atleat 5-10 yrs experience in ROW markets. Approval in tablet and capsule is a must.
||Handling production activity at Sarigam,Gujarat plant.
||BE in Electrical and Mechanical. 15-20 yrs experience of facility of tablet and capsule production. Strong exposure to regulated audits.
||Maintenance work at Indore plant. I=Handling installation and commissioning of production related equipments. Handling maintenance audits.