Quality Specialist Deputy RP Annacotty

We are currently looking for a Quality Specialist& Deputy RP.

The Quality Specialist and Deputy RP shall be responsible for the overall maintenance of the Uniphar Group Quality Management System (QMS) at the Wholesaler site in Annacotty. This role shall be responsible for the Quality and Regulatory compliance at the Annacotty sites by ensuring compliance with current Good Distribution Practice. The candidate shall be responsible for the execution of all aspects of the Group Quality System and ensure the relevant Wholesale Distribution Authorisations (WDA) is maintained for the site. Shall act as a point of contact for all Regulatory Authority Interactions and support all inspections and audits at the site.

MAIN DUTIES & RESPONSIBILITIES

• Maintain the WDAs for Annacotty sites Act as the Deputy Responsible Person for the site and be responsible for the compliant management of the site by demonstrating adherence to cGDP (current Good Distribution Practice):
• Ensuring QMS is maintained and updated as required.
• Investigation of Temperature excursion.
• Management of weekly temperature monitoring records.
• Oversight of stock adjustment and discrepancies.
• Management of authorised activities and ensuring the accuracy of quality records.
• Ensuring that initial and continuous training programmes are implemented and maintained.
• Coordinating and promptly performing any recall / Quarantine operations for medicinal products.
• Assist Uniphar Group in the investigation of customer complaints as appropriate.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• Keeping appropriate records of any delegated duties.
• Deciding on the final disposition of rejected, recalled, or falsified products.
• Ensuring that any additional requirements imposed on certain products by national law are adhered to.
• Act as a contact with HPRA.
• Maintain HSE Food Safety Registration.
• Perform all activities in compliance with Uniphar Group safety standards and SOPs
• Liaise and support regulatory inspection activities and with pharmaceutical inspection teams.
• Support compliance with the Group quality system.
• Support the weekly & monthly reports/KPIs summarising information regarding all the above.
• Participating in continuing professional development in order to maintain awareness in current and new regulations and ensuring new regulations are implemented.
• Other projects as assigned

QUALIFICATION, EXPERIENCE & SKILLS REQUIRED

• Relevant experience in pharmaceutical distribution environment
• Third level qualification in scientific discipline
• Deviation and Root Cause Analysis Experience
• Proven problem-solving ability in a busy, fast-moving environment
• Validation experiences an advantage
• Good working knowledge of Microsoft applications
• Experience in an SAP environment preferred
• Experience working with Quality Management Systems

COMPETENCIES

• Excellent communication skills both verbal and written
• Excellent organizational skills
• Ability to adapt to changing priorities
• Attention to detail and accuracy with the ability to complete tasks fully in a busy environment
• Self-motivated and capable of working independently, however can work as part of a team