Sr. Manager – Lead QMS – Quality Control | Sun Pharma | Baska

Job Description

Roles and Responsibilities:

• Experience of analytical instrument handling like HPLC, GC, UV, IR, Dissolution tester, Ion chromatography, AAS, etc.
• The Candidate should be handling investigation, OOS/OOT , Unplanned deviation , lab event and change control /CAPA in Trackwise Viz logging , investigation , approval & closure, further effectiveness check with coordination of cross functional team and subject matter experts.
• Performing trend analysis of batches and QMS tool and CAPA to assess any emerging trend and escalate to site management to recommended CAPA whenever applicable.
• Must have experience regulatory inspection like USFDA, CANADA , MHRA etc.
• Performing quality risk assessment triggered from various QMS tool and ensure the implementation and effectiveness of identified mitigation actions.
• Prepare quality matrix presentation by compiling various QMS data as per regulatory requirement and escalate to the higher management.
• Performing gap assessment for site QMS procedure to make in line with global policy to enhancement of compliance as per update on regulatory guidance.
• Prepare audit compliance report for observation given by regulatory , customers and other corporate audits under guidance of HOD and coordination with concern department.
• The Candidate should have experience preparation and review of standard operating procedure for quality control department.
• Must have experience on handling of lab software like chromatography software i.e Empower and Chromeleon and LIMS /EDMS.

Desired Candidate Profile :

• M.sc (Chemistry) / B.Pharm / M.Pharm with Experience from 12 to 15 years in Sterile injectable, Ophthalmic , BFS, etc.

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