For a large pharma company in Ghana, manufacturing Tablets,
Capsules,Liquids, Ointments, Powders etc.
Area :- 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, GMP 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 management
(Please note that though the designation is Sr.Manager / Manager, this is a hands-on job. It means that the manager has to do most of the work by himself and at the same time supervise other staff in the Q.C department.)
Should be M.Pharm/ B.Pharm/ M.Sc with 10+ years experience in Quality Control functions with a WHO-GMP certified formulations plant. Must be at Manager level or eqv at present. Those who have overseas work experience would have an added advantage (not compulsory).