Designation: AGM QA- API - Dahej
Reports to: VP Ã¢â‚¬" Corporate QA & RA
Reportees: Manager / Assistant Managers / Executives in the QA & QC team
Educational Qualification: M.Sc(Chemistry) / B.E (Chemical Engg) / B.Sc(Tech) in Pharmaceuticals preferable Masters in Regulatory.
Ã¢â‚¬Â¢ Manage and lead Quality / Compliance initiatives to continuously improve existing Quality Systems.
Ã¢â‚¬Â¢ Keeping the site in compliance for all time readiness for any regulatory audit.
Ã¢â‚¬Â¢ Proper investigation of failure, incident, market complaint and OOS/OOT.
Ã¢â‚¬Â¢ Manage Change Control, Planned / Unplanned Deviation and CAPAs for R&D (Product Development and Analytical Development.)
Ã¢â‚¬Â¢ Risk assessment and risk control with respect to facility and process
Ã¢â‚¬Â¢ Perform cGMP audit of internal R&D facilities and operations and also of 3rd Party vendors and follow up with corrective action.
Ã¢â‚¬Â¢ Implement and maintain Quality Manual.
Ã¢â‚¬Â¢ Must have personally faced USFDA / EDQM or other regulatory audits by being in the core team managing the auditors.
Fact Personnel Pvt. Ltd. shall perspire to continuously research and innovate new methods... of recruitment to facilitate easier and faster recruitment and of quality personnel.
Fact Personnel Pvt. Ltd. shall always perspire to extend its horizon to entire world, and provide world class service to its clients and its candidate as well. It shall perspire to become a knowledge house for its candidate and other people involved so as to contribute to development of every single person. We consider it as our duty as not only to locate the best talent available but also to contribute to the development of individual talents as well in whatever small way we can. Read full description