Site Manager- External Supply
3 weeks ago
Key Responsibilities:
1. QMS and Regulatory Compliance:
o Implement and monitor QMS requirements at contract manufacturing sites.
o Conduct QMS and EHS gap analysis and mitigation.
o Ensure all-time GMP audit readiness and follow up on audit compliance.
o Ensure Quality events/ quality-related issues are managed timely and in a compliant way to ensure timely product release.
o Support contract sites in continuous quality improvement.
o Ensure compliance with regulatory requirements to avoid supply disruptions and punitive actions.
o Review and Maintain Quality Agreement, product specifications, artwork, Product Performance Reviews (PPR), Batch records, analytical records, Stability study documents and other GMP documents at site.
o Review and monitor Product Performance Reviews (PPR) for all products.
o Ensure audit readiness and compliance with audit findings.
o Implement CAPA arise out of different QMS events.
2. Manufacturing support and Product Release
o Track and support timely release and delivery of raw material, packing materials and finished products by resolving quality-related issues.
o Assist contract sites in improving their contribution to business performance management.
o Resolve product supply issues promptly.
o Provide daily batch-wise tracker status and GEMBA reports to stakeholders.
o Ensure timely communication of Quality Alerts to CMOs and coordinate necessary remediation.
3. Product Lifecycle Management (PLM):
o Review and approve Product tech transfer documents.
o Drive Tech Transfer, Process validations and Continued Process Verification.
4. Training and Development:
o Conduct GMP trainings at site, Complete assigned training within due dates. Follow development plans and track progress with line managers.
5. EHS and Statutory Compliance:
o Ensure Environmental Health and Safety (EHS) and statutory audit compliance at CMOs.
o Close agreed CAPAs within timelines.
6. Business and Project Support:
o Participate in Business Review Meetings (BRM) with CMOs.
o Escalate outstanding issues to the ES Quality Operation Lead.
o Support project security plans for alternate sources for API/excipients and CRSF projects.
o Contribute to quality improvement projects and cost reduction initiatives.
Key Competencies:
• Pharmacy/Science Degree with 6+ years of experience in Manufacturing and Quality Assurance, Preferably in Tablet and Capsules dosage forms.
• Strong understanding of cGMP and QMS.
• Excellent regulatory compliance and audit readiness skills.
• Effective issue resolution and decision-making capabilities.
• Strong communication and documentation skills.
• Ability to work collaboratively with cross-functional teams.
Note: This job description outlines the primary duties and responsibilities of the position but is not exhaustive. Additional tasks may be assigned as necessary.
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