QA MANAGER

Job Description : QA MANAGER POLAND Open to International candidates ? Minimum 15+ years of experience in Sterile Oncology Facility. ? Current organization must also be a Sterile Oncology Manufacturing Facility. ? Greenfield Project Oncology ? Strong exposure to IPQA, QMS, Validation, Regulatory Compliance, Documentation & Leadership. ???? Key Job Responsibilities: Quality Assurance Leadership Lead and manage the complete QA function for Sterile Injectable Oncology Manufacturing. Develop a high-performance QA team and ensure continuous quality improvement. Drive cross-functional quality initiatives and operational excellence. IPQA (In-Process Quality Assurance) Monitor all manufacturing and packing activities. Ensure strict compliance with approved BMR/BPR, SOPs and GMP requirements. Perform line clearance, in-process checks and shop floor compliance. Quality Management System (QMS) Manage Deviations, CAPA, Change Control, OOS, OOT, Market Complaints and Risk Assessments. Review, approve and monitor QMS effectiveness. Ensure timely closure and effectiveness verification. Qualification & Validation Review and approve IQ, OQ, PQ protocols and reports. Handle Process Validation, Cleaning Validation, Equipment Qualification and Media Fill Validation. Ensure compliance with Validation Master Plan (VMP). Documentation & Compliance Review SOPs, Specifications, Master Documents and Batch Records. Ensure ALCOA+ and Data Integrity compliance. Maintain GDP and documentation systems. Regulatory & Audit Lead USFDA, MHRA, EU GMP, WHO GMP and customer audits. Ensure inspection readiness at all times. Coordinate audit responses and CAPA implementation. Vendor & Quality Systems Vendor Qualification and Supplier Audits. Quality Agreements and Material Approval. Product Quality Review (PQR/APQR) management. Leadership Role Lead QA, IPQA and Validation teams. Coordinate with Production, QC, Engineering, Warehouse and Regulatory departments. Drive compliance culture, productivity and continuous improvement initiatives.

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