Manager/Sr Manager - Audit & Compliance - Pharma

We have an opening with Pharmaceutical MNC based at Visakhapatnam is looking for Manager / Sr. Manager - Audit & Compliances

Experience : 12+ Years

Qualification : B. Pharm., MSC., M.Pharm

Location : Visakhapatnam

JD:

- Manage and monitor internal, third party manufacturing/distribution, material supplier and service provider audits.

- Develop and implement a robust global model for an effective site audit program (i.e. infrastructure, reporting structure, resources, expertise, qualification risk-based scheduling approach

- Develop and implement strategy that ensures that site clearly understands and have remediation strategy for managing compliance gaps.

- Develop and implement educational tools and guidelines that will improve the overall capabilities and consistency of global internal audit programs (i.e. auditing guidelines, regulatory trends, regulatory references, audit report and response template, metrics)

- Review and approve Risk Assessment reports.

- Review and approve the procedure and other documents to conduct Audits.

- Review and approve executed Audit Reports.

- Review and approve the Audit Schedules conducted as per schedule.

- Review and approve trends for inspections (external and internal) and provide to concerned.

- Ensure site for inspection readiness.

- Support audits from Health Authorities.

- Ensure compliance of site procedures for internal audit and Supplier Quality Management with Global procedures.

- Review and approve company Inspection observations and global commitments to assess impact on Vizag site and implantation of corrective actions if any.

- Review and approve of metrics for audits and associated CAPA’s.

- Review and approve the completion of audit CAPA actions and verify the effectiveness.

- Check and verify proof book of audit observations.

- Review and approve Quality Technical Agreements with Suppliers and third party manufacturers and Distributors.

- Review and approve the Approved Supplier List and Approved Material List.

- Review approve and manage vendor qualification and supporting documents.

- Ensure cGMP compliance on shop floor.

- Conduct team meetings where required

- Participate in Supplier Quality Management meetings.