Manager-1

4 days ago

Vadodara, India Sun Pharmaceutical Industries Ltd Full time

Manager of Corporate Quality Compliance Responsible for review of.
- Responsible for identification and preparation of Best practice Guide documents to enhancement of Lab efficiency/Error reduction.
- Support to sites for conduct of regulatory inspections; which includes review of critical QMS documents/Investigations and tracking of open actions from various functions.
- Responsible for monitoring the implementation of all approved BPDs at sites,
- Responsible to establish tracking mechanism to measure effectiveness of the applicable system.
- Ensure effectiveness of BPDs are monitored through trending of Lab Events & OOS/OOT and identify improvement areas
- Responsible for Monitoring effectiveness of CAPA (Corrective & Preventive Actions) initiated from OOS/OOT and Lab event investigations
- Responsible to perform the gap analysis of global procedures (GQS/GSOPs and policies) against current guidelines and regulatory expectations
- Responsible for the assessment of approved GQS/GSOPs, identify GQS/GSOPs are to be implemented as mandatory, and work with sites/clusters team for logical implementation and meeting GMP regulations and requirements.
- Review the investigation of Out of Specifications and out of trends/Lab events, or any other specific investigation, as needed.
- Communicate with site quality personnel and site quality leadership about the investigations review outcome on timely manner, so that site quality personnel will ensure the gaps identified are addressed before closure of investigations
- Shall prepare a report of lessons learned from the investigations/ review and share it with other Sun sites.
- Provide technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance.
- Ensure implementation of appropriate business processes and control including SOPs, in order to maintain effective quality standards.
- Review and assess industry compliance trends and warning letters and 483s related to laboratory investigations and use the knowledge gained during review of sites investigations.
- Interact with other Corporate Quality individuals when needed and work as a member of a team to achieve all outcomes.
- Ensure consistent and flexible approach towards global regions time zones and travel if required to conduct lesson learned.
- Maintain a working knowledge of EDMS, LMS, Track wise and other software’s relevant to the day today activities.
- Works as a member of team to achieve all goals.
- All other duties as assigned by reporting manager.

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