GM

Job Description : GM QA STERILE MANUFACTURING GERMANY Open to International candidates with 25+ years experience Eligibility Criteria: ? Sterile Injectable Manufacturing Background is Mandatory ? CDMO (Contract Development & Manufacturing Organization) Exposure is Mandatory ? Proven experience in leading Quality Assurance functions in a regulated sterile manufacturing facility. Key Responsibilities: • Lead the complete Quality Assurance function for a sterile manufacturing plant. • Ensure compliance with cGMP, WHO-GMP, EU-GMP, USFDA, MHRA and other global regulatory requirements. • Drive Quality Management System (QMS), including Change Control, Deviations, CAPA, Risk Management, Document Control, Complaints, APR/PQR and Vendor Qualification. • Oversee IPQA activities across aseptic manufacturing, filling, packing and warehouse operations. • Lead Qualification & Validation programs including Equipment Qualification (DQ/IQ/OQ/PQ), Process Validation, Cleaning Validation, CSV and Utility Validation. • Ensure robust aseptic practices, contamination control strategy (CCS), environmental monitoring and data integrity compliance. • Review and approve validation protocols, reports, SOPs, specifications, BMR/BPR and quality documents. • Handle regulatory inspections, customer audits and corporate audits with successful compliance outcomes. • Develop quality culture, mentor QA teams and drive continuous improvement initiatives. • Coordinate effectively with Production, QC, Engineering, Warehouse and Regulatory Affairs for smooth plant operations.

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