- Documentation (Preparation of any document required for a manufacturing plant and R&D, their review, giving them a final ready-to-approve shape/approval)
- Vendor management (Vendor audits, preparation of audit reports, review of compliance reports, vendor qualification etc)
- QMS including product complaints, deviation, change control, OOS & QRM
- Failure Investigation and RCA
- Good working knowledge in various regulatory requirements like USFDA,UKMHRA, SAHPRA, AusTGA, NZMedsafe, France ANSM, D&C Act & Rules, India, WHO, etc.,
- Preparation and review of PDRs of any formulation as part of dossier
- Review of dossier (as per ICH)
- Designing of a project (OSD/Oral liquid plant/ Topicals / Injectables)
- Shall be Good in utilities of a pharmaceutical plant like HVAC, Purified water plant etc.
- Good in preparation of PowerPoint presentations on any GMP related topic & imparting training on the same.
- Shall be able to set up an analytical laboratory independently (analytical development laboratory, in-house QC and commercial testing laboratory as per GLP) Equipments' required for a manufacturing plant, finalisation of the equipments' vendors, price negotiations, purchase and qualification/validation
Salary: INR 25,00,000 - 35,00,000 P.A.
Functional Area:Top Management
Role:Head/VP/GM-Quality Assurance & Quality Control
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Sc - Any Specialization, Chemistry
PG:MS/M.Sc(Science) - Any Specialization
Pharma Placements Inc.
Recruiter Name:Sudhir Vinayak
Contact Company:Pharma Placements Inc.
Address :G-55, Ground Floor, A Wing,, Express Zone Mall, Opp Reliance Power, W.E.Highway Goregaon (East)