Our client based in Sligo are looking to hire a QA Compliance Specialist on an initial 12 month contract.
The Role:
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.
Responsibilities:
- 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 AbbVie Global Quality Assurance, FDA, HPRA and other regulatory bodies.
- Regulatory review.
- Initiation and Completion of Quality related investigations and verification of the effectiveness of CAPA’s as required.
- Establishing Corrective / Preventive Action system 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
Requirements
- 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.
michelle.mcinerney@collinsmcnicholas.ie
091 706717