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QA Specialist Contractor

Job description

The QA Senior Specialist is responsible for  implementing and monitoring the operation of the Quality Management systems in place under the company’s Wholesale Distribution Authorization according to current legislative requirements including EU Good Distribution Practice

 

Essential Job Duties and Responsibilities:

 

  • Ensure that a quality management system proportionate to the distributor’s activities is implemented and maintained including: self inspection; quality risk management; corrective and preventative actions (CAPA) to address deviations; recall; change control; vendor management

  • Paricipate/lead in internal and external compliance audits

  • Support regulatory inspections

  • Collaborate cross-functionally with local and global colleagues  to ensure all quality standards are adhered to and to identify and implement process improvements in distribution of materials and finished products

  • Participate in inter-site global projects

  • Liaise and co-operate with all regulatory bodies on behalf of the company

  • Manage authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP

  • Ensure relevant customer complaints are dealt with effectively

  • Coordinate with MAH and CMOs and promptly perform any recall activities required for medicinal products

  • Co-operate with marketing authorization holders and national competent authorities in the event of recalls

      

Job Requirements:

 

Minimum of a Bachelor’s Degree in Science or a healthcare related field and a minimum of 4-6 year's relevant experience of medicinal products is required.

  • Excellent knowledge of Good Manufacturing Practice(GMP), Good Distribution Practice (GDP) Wholesale Distribution Authorisation (WDA).

  • Experience of working in a virtual supply chain environment a distinct advantage

  • Working knowledge of logistics and serialization would be desirable.

€300 daily rate contractor based in Dublin City Centre - contact Clara on 01 4744676 or email chenry@sigmar.ie

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