Manager- Quality

Job Description : Manager- Quality Control - QMS - Pharma Manufacturing facility IRELAND Open to International candidates Department: Quality Control -QMS - data integrity/Documentation/laboratory oversight/audit ownership/strategic leadership - for global markets Experience: 15 years Core Job Responsibilities 1. Management of Quality Systems (QMS) Deviation Management: Leading the investigation into laboratory deviations. This includes performing "Root Cause Analysis" (RCA) using tools like Fishbone diagrams or the "5 Whys" to determine why a test or process failed. CAPA Coordination: Overseeing the implementation of Corrective and Preventive Actions (CAPA) to ensure that laboratory errors do not recur. Change Control: Reviewing and approving changes to laboratory processes, equipment, or analytical methods to ensure they don't negatively impact product quality. OOS/OOT Investigations: Steering Out of Specification (OOS) and Out of Trend (OOT) investigations. You are responsible for ensuring these are scientifically sound and completed within regulatory timelines (usually 30 days). 2. Data Integrity & Documentation ALCOA+ Compliance: Ensuring all laboratory data is Attributable, Legible, Contemporaneous, Original, and Accurate. Audit Trail Reviews: Periodically reviewing electronic audit trails of analytical instruments (HPLC, GC, UV) to ensure no data has been deleted or manipulated. Dossier Support: Reviewing technical data packages for regulatory filings (ANDAs/Dossiers) and ensuring that the data in the filing matches the raw data in the lab. 3. Laboratory Oversight (OSD & Injectables) Method Validation & Transfer: Overseeing the validation of new analytical methods and the transfer of methods from R&D to the commercial QC lab. Stability Management: Managing the stability testing program to ensure products remain effective throughout their shelf life under various climatic conditions (Zone II, Zone IVb, etc.). Specification Management: Reviewing and approving specifications for raw materials, in-process samples, and finished products (tablets, capsules, or sterile vials). 4. Regulatory Audit Leadership Front-Office Representation: Serving as the primary technical expert for QC during regulatory inspections (USFDA, EMA, TGA). You must defend the laboratory’s QMS processes and investigation reports. Internal Audits: Conducting self-inspections of the QC department to identify gaps before official inspectors arrive. Compliance Gap Analysis: Staying updated on New Pharmacopoeial (USP/EP/BP) monographs and ensuring the lab updates its methods accordingly. 5. Strategic Leadership & Operational Excellence Training Management: Vendor Management: LIMS Implementation: Budget & Resource Planning:

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