QA Compliance Officer
Our Galway based client are looking to recruit a QA compliance officer. The successful candidate will assist in the process of maintaining compliance to Product Licenses / Marketing authorisations.
• Conduct Routine Quality Audits of the facility to ensure compliance with current EU GMP, be proactive in resolving issues which may arise.
• Set up and maintain the Internal Audit schedule and ensure its completion as per schedule.
• Prepare and conduct annual GMP training programme.
• Conduct External audits, compile External Audit reports and manage associated responses.
• Management and assistance with the site change control system.
• Management of the customer complaints system and associated CAPA’s.
• Provide technical support for New Product Introductions and existing Products, ensuring compliance with the registered dossier
• Review /lead Process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.
• Ensure Process transfer is documented and conducted in accordance with Regulatory Standards.
• Quality review and approval of manufacturing documentation & third party contract manufacturing.
• Provision / Updating of existing Quality Manual Procedures in order to ensure compliance with EU GMP
• Contributing to the overall improvement of the company from a Quality / GMP perspective with an emphasis on continuous improvement of the quality system.
• Preparation of Key Performance Indicators for the Quality department and also assisting in the maintenance of records for the company KPIs as per Quality management review requirements.
• Ensure timely feedback on customer/production queries as appropriate.
• Preparing product quality review schedule and reports and third party contract manufacture products.
• Assist in product investigations and ensuring risk assessment approach is applied
• Management of the deviation system and associated CAPA’s.
• Collating monthly trends and assisting the Quality Material Review Board meetings.
• Degree in Science discipline or equivalent.
• Minimum of 3 years Quality Assurance experience within the pharmaceutical industry B.Sc. degree as a minimum requirement.
• Strong organisational skills / ability to prioritize work
• Proven track record as a team player.
• Excellent communication and presentation skills with a hands-on approach
Clodagh Nerney | Tel: +353 (0) 1 507 9254