Our client based in Sligo are looking to hire a QA Compliance Specialist on an initial 12 month contract.
As the QA Compliance Specialist you will be responsible for documenting and establishing a quality system which ensures full compliance with all regulatory standards. You will be responsible for reporting on the effectiveness of the quality system to senior management.
Coordinating the quality system, ensuring full compliance by all personnel with its requirements.
Coordination of Product Quality Reviews activities.
Management of all Technical Agreements from initiation, review, approval and storage.
Coordination and Management of all Track and Trend activities to support Manufacturing and QC.
Driving a QRM approach to all activities on site.
Coordination and facilitation of all Site RCS and FMEA activities.
Auditing the quality system per the documented internal audit schedule. Assisting in the documentation, investigation of and coordinating customer complaints/exceptions by ensuring implementation of effective corrective / preventive action where necessary.
Ensuring that products manufactured at Company XXX meet requirements of end users, of regulatory authorities and of the company.
Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings.
Coordinating change management, change control and Change planning activities.
Monitoring quality performance and advising management personnel on major quality issues.
Liaison with Global Quality Assurance, FDA, HPRA and other regulatory bodies.
Initiation and Completion of Quality related investigations and verification of the effectiveness of CAPA’s as required.
Establishing Corrective / Preventive Action systems and procedures.
Management of the Supplier program including the ASL, Performance metrics and Audit Schedules
Creation and approval of commodity specifications as required Performance of Vendor audits as required
Support all aspects of inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.
Adheres to and supports all EHS & E standards, procedures and policies
Third-level degree in a science, quality or engineering discipline.
A minimum of three years experience in a quality/operations role in a highly regulated manufacturing GMP environment (Pharmaceutical/Biologics/Medical Device)
A strong knowledge of regulatory requirements is required.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.