PurposeRecruitment of New Position.Position / Job TitleAssistant Manager (Supervisor).DepartmentQuality Control Reporting ToSr. Manager (P4) / AGM (M1) LocationAmbernath Years of Experience8 to 12 years.Dosage FormSolid Oral / Nasal / Liquid Job Responsibilities / Deliverables
He is Responsible to leading LCMS instrumental team (Approx 5 members) with planning and execution for RM, Finished Product Samples and Stability Samples testing. He is primary responsible and main role to arrange the Extractable, Leachable, Nitrosamine-NDSRI impurity, other organic impurity etc testing on LCMS (Sciex).
Responsible for arranging a review of analytical raw data for correctness and completeness and to ensure final data submission to QA or other respective departments as per specified timelines.
He is responsible for arranging the method validation, verification, method transfer activity as when applicable on LCMS and train-qualified the people on LCMS testing.
The candidate should have handling experience in LCMS (Sciex), HPLC (Shimadzu) and other instruments like UV, IR, GC instruments will add advantages.
He is responsible to care-taker, calibration and PM of LCMS (Sciex).
He is responsible for QMS handling (incidences, investigations, OOS, OOT, CC, CAPA etc.) and closing within stipulated timeline with proper root cause of his section.
He is responsible for facing the Audit (USFDA/MHRA/Client etc.)
He Should have good written and communication skills.
Responsible for adherence of GLP and Health, Safety Environment system in Laboratory.
Qualifications & Pre-Requisites
Preferably have following skill but not limitas mentioned below;
Master Degree of Science / Pharma.
The candidate should have handling experience and theoretical knowledge on LCMS (Sciex), HPLC (Shimazu), UV, IR and requires knowledge of data review.
He should have experience of QMS Handling and know about GLP-GMP standard of analytical work.
The candidate having experience in US-FDA/MHRA approved company is preferable.
Knowledge of Chromeleon 7.2 software & Sciex OS 3.3 will be an added advantage.
Additional Notes
Role is expected to work in all shifts.
If required, the candidate should be ready to travel to all plant locations on work priority as per company policy.
Responsible to ensure compliance to GLP, Health, Safety and Environment. requirement.
