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Barden are delighted to be supporting our Global Pharmaceutical client in their search for Quality Assurance Specialist in Cork.
ABOUT THE ROLE:
The primary responsibility of the Quality Assurance Specialist will be to support the maintenance and improvement of the QMS and QA activities, ensuring compliance with cGDPs, while also supporting regulatory affairs.
RESPONSIBILITIES:
- Maintain the quality system and ensure that it demonstrates adherence to Good Distribution Practices (GDP’s).
- Track supplier approvals and ensure that due diligence is conducted at regular intervals.
- Ensure that supplier’s & customers are qualified as per internal procedures.
- Support and monitor the implementation of existing & new quality related agreements and fulfilment of the organization’s technical obligations focusing on maintaining compliance.
- Address and resolve quality events to solve problems and improve systems by working with internal and external parties, develop and implement corrective and preventative actions and document quality event resolution.
- Liaise with the Quality Manager on regular Quality review meetings, identifying opportunities for improvement.
- Manage the Corrective & Preventive Action process and ensure effective CAPA’s are implemented following identification of a root cause and approval from the Quality Manager/RP.
- Support external audits with regulatory agencies and support close out any findings in a timely manner.
- Ensure that all good distribution records are maintained, and records are accurate.
- Support on change controls, self-inspections, deviations, recalls and customer complaints and other Quality Assurance activities when required.
- Manage & develop the key performance indicators (KPIs) to monitor areas of Quality and identify areas for improvement.
- Lead relevant parts the electronic Document Management Application and identify areas for development to improve productivity.
ABOUT THE PERSON:
- Minimum of 1-3 years’ experience in cGMP / GDP Quality environment.
- BSc in a scientific discipline
Hi, we’re Barden. We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.
