Senior Executive

2 weeks ago

Dewas, India SUN PHARMA Full time

Job Description

Position: Sr. Executive

Department: Block P

Total years of experience: 5+ Years

Job Role: Handling of block QMS activities and other Improvement Projects.

Education Qualification: B. Pharmacy

Responsibilities:

Preparation, review, follow-ups and closure (end to end) of following QMS activities Preparation of investigation including unplanned deviations, product quality complaints, OOS & OOT by using suitable investigation tools like 6 M, Ishikawa, 5 why technique. Review of prepared investigation with compliance from CFT and closure in track wise system. Initiation, report preparation and closure of planned deviation. Handling change controls from preparation of proposal, approval of proposal from CCR committee, initiation of CCR, report preparation, protocol preparation, SOP draft preparation etc. to final closure. Handling of track wise system w.r.t. all QMS activities including Impact assessment and Risk assessment. Preparation of audit response for observation received form internal/external audits, third party manufacturing or received at other sites. Gap assessment with respect to other regulatory agencies guideline line Schedule M, EU-annex part-I. To implement the recommendation of internal/external audits outcome. To ensure contamination control are available and followed at site as per Contamination Control Strategy (CCS) and respective procedures. To follow & implement the current Good Manufacturing Practices, EHS practices and SOP during work.

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