Country / Zone Quality Manager
Plans and maintains quality assurance systems to ensure process and test reliability and conformance to company, customer and regulatory requirements. As a member of the management team contributes to performance of the company and provides inputs and suggestions on normal routine business matters.
Responsible for quality assurance relating to:
- Ethylene Oxide and E-beam irradiation facility at Tullamore,
- Gamma irradiation facility at Westport.
- Testing services facility at Galway
Responsible for supporting Site Quality Manager and Global Laboratory Director with quality assurance relating to:
- Laboratory facility at Tullamore
DUTIES AND RESPONSIBILITIES:
- The Quality Assurance Manager has specific and general responsibilities in respect to the Quality System:
- The QA Manager is the designate Responsible Engineering Manager in regard to the MHLW, Ordinance No. 169, 2004 of JPAL.
- The Country/Zone Quality Manager is the Designated Management Representative with the authority and responsibility to ensure the documented Quality System is implemented.
- The Country/Zone Quality Manager supports the Site Quality Manager with regards to Irish National Accreditation Board (INAB) (supports Audits, responses to audits, overall responsibility to ensure QMS aligned with company requirements, supports Site Quality Manager on INAB compliance requirements).
- Ensures Audits, associated reports and quality plans are implemented and verifies that the necessary corrective actions are taken to ensure ongoing compliance with the Quality Manual.
- Actively part-takes in Management review process at all company business units thereby ensuring that all issues relevant to maintaining the continuing suitability and effectiveness of the Quality System are addressed.
- The Country/Zone Quality Manager has specific authority and responsibility to:
- Initiate action(s) to prevent the occurrence of process non-conformity(ies).
- Identify and record and process quality problems.
- Initiate, recommend or provide solutions to quality problems through designated channels.
- Verify the implementation of solutions to quality problems.
- Control further processing, delivery or release of customer product pending completion of corrective action on non-conforming process.
- Responsible for ensuring appropriate systems are in place for the release of client product post processing.
- Analyses customer complaints and implements corrective actions to eliminate re-occurrence of issue for justified complaints.
- Responsible for Document Control function.
- Responsible for all Customer and regulatory audits and responses to those audits and ensuring the promotion of awareness of regulatory and Customer requirements throughout the organisation.
- Responsible for ensuring process commissioning, validation and any subsequent revalidations deemed necessary as a result of facility engineering changes or customer product/requirements changes are documented, approved and implemented.
- In conjunction with the Technical and E-Beam Departments, 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 ensuring supplier controls maintained.
- Maintains liaison with national and other regulatory agencies as required to ensure company Quality Standards remain in compliance.
- Actively engages as pert of the Management Team and provides support and advice to other functional area managers/supervisors as required.
- In the event of an adverse Quality issue being detected, the Country/Zone Quality Manager has the authority to stop processing and/or testing with immediate effect.
- Life Science tertiary qualification, preferably microbiology or chemistry, plus 3-5 years relevant industrial experience in Quality Department.
- Requires comprehensive knowledge and hands-on experience of quality standards and procedures; ideally, in the area of EO and irradiation sterilisation and validation.
- Working knowledge and experience of medical device, related GMP and an appreciation of the FDA compliance inspections.
- Ability to work well with people and act as a facilitator to company staff not directly reporting to this position is important.
Ability to communicate with clients is essential.