Quality Assurance & Compliance Project Manager

Responsibilities

• Manage, maintain, and improve Quality Management Systems (QMS) in compliance with GMP regulations and applicable regulatory requirements (EU GMP, FDA, ICH).
• Support clients in QMS implementation, remediation, and continuous improvement initiatives.
• Coordinate and implement Contamination Control Strategies (CCS) of Annex 1.
• Participate in internal audits, supplier audits, mock inspections, and regulatory inspections.
• Manage and support quality processes including, Deviations, CAPAs, Change Controls, Complaints, OOS/OOT investigations, Product Quality Reviews (PQR/APR), Batch Record Review, Documentation Management .
• Coordinate and support Validation activities , define validation strategies, acceptance criteria, and sampling plans.
• Support Technology Transfer projects between manufacturing sites and external partners.
• Participate in r...