Quality Compliance Specialist

3 Dec 2021

Key Responsibilities

The Quality Assurance Specialist has a primary role in:

  • Working as part of the Quality Assurance team on site ensuring products are manufactured, in accordance with cGMP
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGMPs, cGLPs, SOPs, regulatory regulations and guidelines
  • Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
  • Participate in the preparation and review of procedures and batch documentation
  • Review and approval of deviation, CAPA’s, quality events, change controls and tasks
  • Acts as Quality Point person for processes providing guidance / feedback on quality issues
  • Work with relevant departments to ensure timely closure of quality actions / findings
  • Actively contribute to continuous improvement initiatives
  • Conduct duties in a safe manner and report all safety issues or concerns

Essential requirements

  • Bachelor’s degree in a science or related discipline is essential
  • Previous experience in a manufacturing environment, sterile experience is preferable
  • Previous experience in a quality control laboratory, microbiology would be preferable
  • Previous experience of working as a quality team member in the biotechnology sector is an advantage
  • Knowledge of regulations and standards affecting biologics and pharmaceutical products
  • Good communication skills at organisation, team and individual levels
  • Must be able to respond quickly to unplanned events, technical issues and changing needs
  • All applicants must be open to shift work (Monday to Friday)

How to apply for the position:

If you are interested in applying for this role, please send in a cover letter with an updated CV to hr@cls.ie

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