Site Manager- External Supply

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.