HEAD OF QUALITY CONTROL
Overall In-charge for Total Quality Control functions
Quality Control Laboratory of Formulation plant/s ONLY.
Apart from testing in QC lab, should be :-
Well versed with all GMP/GLP.
Must have faced audits directly like WHO Geneva, TGA, MHRA, USFDA etc
Good knowledge of guidelines like WHO, ICH, 21-CFR etc
Thorough knowledge of OOS/OOT/Calibrations/Analyst qualification.
Exposure of implementation of cleaning validation.
Complete awareness of working principles of QC instruments like AAS, GC, HPLC, FTIR,UV etc.
Knowledge of handling microbiology lab.
Stability Studies testing and management.
Vendor qualification knowledge.
Water testing and trending.
Area testing for viable and non viable count.
Good Communication skills and ability to work smoothly in cross departments.
Strong in man to man management
M.Pharm / B.Pharm /M.Sc graduates with 12+ years experience in Quality Control functions for pharmaceutical formulations, experienced in facing regulated market audits like US-FDA / MHRA / WHO-Geneva / TGA / EU etc, who is at Senior Manager -Q.C or above position at present with a reputed pharma company exporting finished formulations to the regulated and semi-regulated markets.