Quality Manager - Ireland

Posted 1 day 7 hours ago by Ashland Inc.

Permanent
Full Time
Manufacturing Operations Jobs
Not Specified, Ireland
Job Description
- Act as the site Quality Management Representative, including: Representing Ashland during regulatory inspections, certification audits, customer audits, and company visits Ensuring processes required for the Quality Management System (QMS) are established, implemented, maintained, and continuously improved Reporting on QMS performance, compliance status, risks, and improvement opportunities to senior and global management Promoting awareness of regulatory, quality, and customer requirements across the organization Technical experience and/or working knowledge of a range of analytical laboratory techniques, including but not limited to GC, ICP MS, Karl Fischer, potentiometric titration, GPC (size exclusion chromatography), and polarimetry, sufficient to provide effective oversight of QC laboratory activities, data review, and investigations. Ensuring laboratory activities complies with approved methods, SOPs, GMP, and data integrity requirements Oversight of laboratory readiness for inspections, including instrument qualification, calibration, and documentation practices- Own and maintain the site Quality Management System, including: Implementation and maintenance of Quality systems, procedures, documentation, and training programs in line with ISO 13485, EXCiPACT, ICH Q7, and applicable GMP requirements Management of deviations, non conformances, CAPAs, change controls, complaints, and risk management activities Preparation and approval of quality and regulatory documentation in accordance with internal procedures and external requirements Level 8 (or higher) qualification in Science (Chemistry), or a related discipline; postgraduate degree advantageous 3+ years' experience in a GMP regulated manufacturing environment with people leadership responsibility Strong knowledge of QMS and regulatory compliance (ISO 13485, IPEC GMP, ISO 14971, or equivalent) Proven experience managing deviations, CAPAs, change control, audits, supplier quality, and complaints Working knowledge of key analytical QC techniques (e.g. IV, GC, ICP MS, Karl Fischer, potentiometric titration, GPC/SEC, polarimetry) sufficient for laboratory oversight Understanding of equipment qualification, process validation, and cross functional project delivery Strong problem solving, ethical judgment, and ability to drive value through risk based decisions