PurposeRecruitment of Replacement Position
Position / Job TitleManager (Supervisor / Section In-Charge).
DepartmentQuality Control
Reporting ToSr. Manager (P4) / AGM (M1)
LocationAmbernath
Years of Experience11 to 15 years.
Dosage FormSolid Oral / Nasal / Liquid
Job Responsibilities / Deliverables
- Responsible for leading the team of Approx 10+ members (Analyst + Reviewer) for respective section and release the batches after completion of analysis or any other given task as per target completion date.
- Responsible for arranging a review of analytical raw data for correctness and completeness and to ensure final data submission to QA or other respective department as per specified timelines.
- He is responsible for QMS handling (incidences, investigations, File notes, ratification, OOS, OOT, Change Control, CAPA etc.) and closing within stipulated timeline with proper root cause of his section.
- To ensure and arrange all resources available to smooth line function as per planning and achieve deliverable task with minimum support.
- He is responsible for facing the Audit (USFDA/MHRA/Client etc.) with respective section related work.
- Should have good written and communication skills and perform the task given by the Sr. Leader as and when required.
- Responsible for adherence of GLP and Health, Safety Environment system in Laboratory.
Qualifications & Pre-Requisites
Preferably have following skill but not limitas mentioned below;
- Bachelor / Master Degree of Science / Pharma.
- He should have good experience of team handing (Analyst + Reviewer) for respective section. He should have past analytical experience of modern instruments like HPLC, GC, IR, UV, IC, KF, Dissolution etc. 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 Chromleon 7.2 software 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.
