Manager

Purpose Recruitment of Replacement Position. Position / Job Title Manager (Supervisor / Section In-Charge). Department Quality Control Reporting To Sr. Manager (P4) / AGM (M1) Location Ambernath Years of Experience 11 to 15 years. Dosage Form Solid 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.