Quality Systems Specialist

Job description

Job Responsibilities:

  • Responsible for day to day activities designed to maintain and enhance the local Quality Management System for 3rd Party and Commercial oversight in line with directive 91/356/EEC, as amended by Directive 2003/94/EC, veterinary directive, Medical Device Directives, ISO13485 as applicable.
  • The Quality Specialist will review and co-ordination of batch records and associated documentation including the generation of product release certificates to support batch release and certification of product.
  • Support the continuous improvement of the QMS including the development and implementation of improved quality reporting measures
  • Effective management and coordination of Quality Management Systems including change control, Deviations, CAPA, SOP’s.
  • Interface between Regulatory Affairs, Marketing and Customer Service personnel where necessary.
  • The Quality Specialist will be responsible for the writing, training and management of SOPs including associated training requirements
  • Maintenance of system to ensure appropriate review and completion of Annual Product Quality Reviews
  • Support or where necessary lead Quality based projects including working as part of a multidisciplinary team as required
  • The Quality Specialist provide direct support during competent authority audits
  • Assist in conducting internal self-inspections and external audits as appropriate
  • The Quality Specialist will provide quality review and approval of artwork components where applicable

Job requirements

  • Bachelor’s Degree required with a minimum of 3 years’ experience in QA/Compliance in pharmaceuticals or related industry.
  • Prior pharmaceutical or quality assurance experience essential
  • Strong analytical skills and knowledge of quality system essential
  • Thorough knowledge of either EU GMPs and/or Medical Device Directives
  • Computer literate essential including working knowledge of MRP system

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