Company: Thornshaw Recruitment
Closing Date: 02 Jan 17
Salary (£): Negotiable
Our client a leading pharmaceutical company now have a new role available for a Quality Manager. This is a full time permanent role reporting directly to the Director of QA.
Overall Purpose of Job:
To ensure that the Quality System is operated in line with the current expectations within the Pharmaceutical Industry and to promote continued development in all aspects of GMP and Quality System.
• Provide quality assurance and technical support across the company and in accordance with GMP requirements.
• Contribute to Quality Strategy and focus on process excellence
• Review of existing Quality Systems to identify areas for process effectiveness and continuous improvement.
• To review trends, metrics and indicators of quality and to facilitate the improvement of key GMP determinants and metrics.
• Optimize processes and manage continuous process improvement using Lean and Six Sigma methodology
• Using CAPA, non-conformances, root cause analysis, audit process to resolve manufacturing and compliance issues.
• Participate as a key contributor in Customer and Regulatory Authority audits
• Review and approval of Customer Quality Complaint Investigation reports.
• Management of the CAPA system to ensure all corrective and preventative actions are implemented and completed within given timelines as per the approved SOP.
• Ensure that all commitments made following customer or regulatory audits are met within the timescales detailed in the relevant responses.
• Review, evaluate and where necessary, approve any deviations which may occur in the manufacturing, packaging or testing of raw materials and finished formulations.
• Conduct Self Inspection audits, as required.
• Conduct Supplier or Service Provider audits, as required.
• Review and approve controlled documentation such as PCRs etc.
• Review and authorise Standard Operating Procedures, as required.
• Proven track record in working in a Pharmaceutical environment
• Knowledge of GMP regulations
• Experience of developing Quality Strategy in line with ICH Q10
• Knowledge of regulatory guidances
• Practical experience of problem solving and root cause analysis
• Excellent communication and interpersonal skills
• Practical experience of working in a team environment
• Experience with product transfers and manufacturing transfers
• 6 sigma green belt training
• Practical experience of pharmaceutical manufacturing including aseptic manufacture, tableting and packaging and API manufacture
For more information and to apply for this role please call Stephanie on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671
Barton House 6 Old Dublin Road Stillorgan Co. Dublin
|Tel:||00 353 (1) 278 4671|
|Fax:||00 353 (1) 278 4672|
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