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
- 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.