Quality Manager (Auditor)

  • Contract
  • Dublin

Website Ref:TPM04653

Summary:
Our client is a global bio pharmaceutical company based in Dublin seeking a Quality Manager (Auditor) who will have responsibility for the management of the GMP, GDP and Medical Device internal and supplier audit programs. Managing the initiation, assignment, execution and close-out of all audit observations and related response actions.

Responsibilities:

  • Maintaining an up-to-date global audit schedule and generating periodic metric reports suitable for viewing by and presentation to Senior Management/leadership.
  • Contributing to the further development of the audit function by shaping our client’s audit landscape through proposals and innovative solutions.
  • Developing solutions to a diverse range of problems that require complex judgements, using highly developed levels of conceptual thought and analysis.
  • Driving, role modelling and supporting a strong lean culture that promotes standardization, simplification and continuous improvement.
  • Maintaining an up-to-date global audit schedule and generating periodic metric reports suitable for viewing by and presentation to Senior Management/leadership.

Qualifications & Experience:

  • A minimum of 7-10 years’ relevant experience within the pharma industry or a related field.
  • 3-5 years’ experience in a QA environment in a leadership role.
  • QP Qualified is desirable.
  • Strong knowledge of cGMP requirements for pharmaceutical manufacturing required.
  • Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
  • Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
  • Excellent accuracy and attention to detail.
  • Good knowledge of relevant computer packages e.g. Trackwise or similar.
  • Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
  • High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management.
  • Technical writing skills required.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.