QUALITY HEAD

Job Description : QUALITY HEAD DUBLIN IRELAND IN PHARMA Open to International candidates Department: Qauality Assurance (Injectables - Onco and Non Onco drugs) - pharma manufacturing for global markets Experience: 20 years or more Qualifications: M.Pharm/B.Pharm/M.Sc/M.Tech Core responsibilities: 1. Quality Management System (QMS) Oversight You are responsible for the health of the entire quality system across both plants. Deviation & CAPA Management: Overseeing the investigation of complex deviations, particularly those involving sterility failures or environmental monitoring excursions. Change Control: Ensuring that any changes in manufacturing processes, equipment, or utility systems (like WFI or HVAC) are validated and do not impact product sterility. Risk Management: Leading Quality Risk Management (QRM) assessments to identify potential contamination risks or cross-contamination in shared facilities. 2. Sterile Assurance & Aptic Process Oversight Media Fill Management: Ensuring the design and execution of Process Simulations (Media Fills) are robust enough to prove the sterility of the aseptic filling line. Environmental Monitoring (EM): Reviewing and trending data from Grade A/B areas. For Oncology plants, this includes monitoring for chemical containment and cleaning validation to prevent cross-contamination. Lyophilization & Sterilization: Oversight of sterilization cycles (autoclaves) and lyophilization (freeze-drying) parameters for global market batches. 3. Global Regulatory Compliance & Audits Audit Leadership: Acting as the primary point of contact for international regulatory inspections (USFDA, EMA, TGA). Dossier Review: Reviewing the QA sections of ANDAs/MAAs to ensure that what is filed with the health authorities matches the actual practices on the plant floor. Market Complaints & Recalls: 4. Plant-Specific Responsibilities: Onco vs. Non-Onco Oncology (High-Potency): Focus on Containment. Ensuring that isolator technology or Restricted Access Barrier Systems (RABS) are functioning to protect both the product and the operator. Overseeing rigorous cleaning validation for cytotoxic residues. Non-Oncology: Focus on high-volume efficiency and sterile integrity across various delivery systems (vials, ampoules, or pre-filled syringes). 5. Operational Quality & Material Management Batch Release: Final review and "Disposition" of batches. You ensure that every vial meets the specifications before it is released for global distribution. Vendor Management: Stability Monitoring: Ensuring that stability samples are pulled and tested according to ICH guidelines for all global markets. 6. Leadership & Technical Training Team Mentorship: Training Programs:

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