Manager - Quality Control (Finished Products & Stability)

Role & responsibilities

• 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.

Preferred candidate profile

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.

• 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.