QMS Professional

Syngene

4 - 7 years

4 - 7 Lacs

bengaluru

Posted:12 hours ago| Platform:

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Skills Required

manager internal audit operational excellence nutrition data management compliance pharma data integrity gmp risk management manufacturing operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Ensure timely reporting of deviations, appropriate investigations to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
Perform the manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and facilitate proposal & implementation of appropriate CAPA to prevent reoccurrence.
Participate in the audits and inspections as SME for deviation management and manufacturing investigations.
Ensure timely proposal and implementation of appropriate CAPA for any audit findings.
Perform timely tracking of Operational and Compliance Metrics for Manufacturing Operations and management reporting.
Ensure Risk Management for Biologics Operations covering following elements and ensure proposal and implementation of appropriate risk mitigation actions (CAPA).

Quality and Compliance Risks
Operational Risks
Data Integrity Risks

Perform and support timely preparation, review and approval of GMP documentations.
Conduct and/or support training on SOPs, protocols and On-the-Job activities.
Participate in regular facility walkthroughs, Self-Inspection and Internal Audit for Biologics Operations to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessments.

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