Our client, one of the largest multinational company based in Dublin is recruiting for QA Manager. This is a key position, which involves ownership and accountability for the quality operations activities across the site. This is a challenging, results-oriented position. QA Manager will have involvement in the preparation, support and follow-up of Regulatory Agency inspections including HPRA, TUV Regulatory Agencies, Corporate & Strategic Partners as well as performing internal audits as required.
·To ensure compliance with the requirements of Good Manufacturing Practice and Good Distribution Practice.
·To co-ordinate the preparation of Annual Product Quality Reviews.
·To co-ordinate the site Change Control process.
·To co-ordinate the site Process Deviation Report process, ensuring that all deviations are effectively addressed including root cause and corrective/preventative actions.
·To co-ordinate the site Customer Complaint process ensuring all complaints are addressed promptly & thoroughly.
·Monitoring of supplier performance and evaluation & qualification of suppliers and potential suppliers.
·Management of recall process and generation of mock recall.
·To ensure adequate records are in place to provide full traceability.
·To ensure all GMP and GDP critical SOPs and batch records are approved by Quality Assurance and to ensure that all QA GMP and GDP related documentation is maintained up-to-date and in compliance with cGMP and GDP requirements.
·Co-ordination of final quality review of batches prior to release by a Qualified Person.
·To ensure adequate reference samples and appropriate records are archived for all products shipped.
·To manage and guide the activities of personnel in QA Department and to monitor and review performance of each member of the Department.
·To assist in the preparation coordination and follow-up on regulatory and customer inspections.
·Induction GMP training and site GMP training
·A primary degree in life science or another related field.
·A Postgraduate qualification which allows the candidate to act as a Qualified Person (desirable).
·A minimum of 5 years working in a similar role or at a supervisory level within quality assurance.
·Experience in maintenance of an ISO 13485 QMS for medical devices is desirable but not essential.
·Experience in implementation of continuous improvement initiatives.
·A good understanding of regulatory requirements.
·Excellent oral and written communication skills.
·Strong organizational skills with the ability to multitask and prioritise workload
·The ability to be self-driven and capable of working on own initiative.
·Experience in performance management and personnel development.
If you would like further Information you can contact the recruiter directly:
Jannet Diana | Tel: +353 (0) 1 507 9255