Quality officer Jobs in Dublin

Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, currently employing over 320 people across two sites in Tipperary and Dublin. Originally established in 1976 to serve the renal care market in Ireland, Pinewood evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).

Key areas of responsibility (include but not limited to) :

• Work effectively as part of a team in supply chain and warehouse departments.
• Maintaining GDP, GMP standards.
• To record, maintain and file all Deviations for the Dublin Site.
• To record, maintain and file all Change Control Forms, CAPA's, Risk Assessment for the Dublin Site.
• Temperature monitoring.
• Maintain housekeeping in one's area and upkeep of their office area.
• Assist in the qualification of Wholesalers and Suppliers through the Bona Fide checks.
• Manage and maintain the training matrix, SOP's and training records for the Dublin Site.
• Record and amend any SOP's for the Ballymount Site and manage the SOP during the approval process.
• Assist the RP in performing audits of approved carriers and any other service suppliers as required.
• Internal and External auditing.
• Investigating customer complaints.
• Prepare monthly Deviation reports on the status of the previous month's deviations.
• Compile a monthly non-conformance report through Eudra on non-conforming customers and suppliers.
• Ensure company SOPs, processes and guidelines are followed at all times.
• Conduct the Transport temperature analysis twice yearly.
• Analysis data provided by the Supply Chain Manager.
• Assist the RP with any recall of products and conduct a mock recall annually.
• Participate in the co-ordination of any internal or external audits (Financial & Quality)
• Prepare and review Wholesaler Technical Agreement's ready for RP review.
• Ensure all issues and queries are responded to in an effective manner.
• Liaise with the Inventory Controller on any non-conformances with deliveries and suppliers.
• Prepare any reports required by the supply chain manager, accompanied by any requested analysis.
• Arrange and schedule any training requested by the supply chain manager.
• Ensure a consistently high level of communication with the warehouse and quality assurance departments.
• To undertake any other duties of a similar level and responsibility as instructed by the Supply Chain Manager.
• Participate in Company stock takes.
• Review goods inwards / batch documentation.
• Any other projects relating to quality standards / requirements as assigned by the Compliance Manager.
• Assist and perform any duties or tasks assigned by the Supply Chain Manager / RP in conjunction with the Compliance Manager.

Key Requirements :