Site Quality Manager

 

In conjunction with the Ireland (Country) QA Manager, responsible for Quality Assurance and Technical matters relating to the facility.

DUTIES AND RESPONSIBILITIES

  • The Site Quality Manager has specific and general responsibilities in respect to the Quality System.
  • Is the Designate Management Representative with the authority and responsibility to ensure the documented Quality System is implemented?
  • Audits, generates reports and quality plans and verifies that the necessary corrective actions are taken to ensure ongoing compliance with the Quality Manual.

Has specific authority and responsibility to:

  • Initiate action to prevent the occurrence of a process non-conformity.
  • Identify and record any process quality problems.
  • Initiate, recommend or provide solutions to quality problems through designated channels.
  • Verify the implementation of solutions.
  • Control further processing, delivery or release of Customer product pending completion of corrective action on nonconforming product.
  • Responsible for ensuring appropriate systems for release of client product post processing.
  • Analyses Customer complaints and implements corrective actions for valid complaints.
  • Responsible for Document Control function.
  • Responsible for facilitating Customer and Regulatory audits including generation of corrective actions and ensuring responses to the relevant third party. Ensuring the promotion of awareness of
  • Regulatory and Customer requirements throughout the organisation.
  • Responsible for ensuring process commissioning, validation and any subsequent re-validation deemed necessary as a result facility engineering changes or customer product/requirements changes are Documented, approved and implemented.
  • Provides technical assistance and support to Customers in the development of validation protocols subsequent validation reports, and routine processing problems.
  • Responsible for ensuring process, test and raw materials specifications remain current, by conduction

REQUIREMENTS:

  • 3-5 years relevant industrial experience in Pharma
  • Requires comprehensive knowledge and hands-on experience of quality standards and procedures; ideally in the area of sterilisation and validation.
  • Working knowledge and experience of medical device manufacturing, related GMP and an appreciation of FDA compliance inspections.

Your Recruitment Consultant is Sean Winstanley

Sean Winstanley
Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.