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Job Details

Quality Manager

Company: Thornshaw Recruitment
Location:
Reference: SM9236
Closing Date: 02 Jan 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

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.

Requirements:

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. 

Main Activities/Tasks: 
• 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. 


Essential Skills 
• 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 


Desirable Skills 
• 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 smullen@thornshaw.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

Apply for this job: Quality Manager

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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