QC Manager (Injectable)

Job Description:

Position:        QC Manager (Injectable)

Location:          Daman

Experience:     5 - 10 YEARS

Industries:       Pharma

Responsibilities:

• Experience in vaccine and biological (Mabs) manufacturing,
• Handled greenfield / brownfield – QC lab, qualification and validation of QC lab and instruments,
• Preparation and review of all QC documents such as SOPs, protocols, reports, etc.,
• USFDA and EU audit handling exposure, responsible for qualification and validation of QC dept: URS, IQ, OQ, PQ of newly installed equipment and instrument in QC dept.,
• Product validation – technology transfer related to QC dept. activities such as assay, RS, in vivo studies, etc.,
• Quality risk assessment and risk analysis as per current regulatory guidelines, managing QMS documentation, inventory of laboratory requirements and all resources for the smooth functioning of QC lab, responsible for trouble shooting and failure investigation, events / incidents, OOS, OOT, etc.,
• Ensure timely completion and traceability of all testing activities performed, adhered to the standards of quality as per GMP, GLP, company quality policies and site SOPs.

Required Skills:

• Logical thinking.
• Organizing.
• Good in communication.

Required Qualification: - B.Sc/M.Sc- Microbiology/Biotechnology/ B.Pharm/M.Pharm

Salary :- Upto 18.00 LPA

If you are interested for this opening please send updated resume or revert on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-