External Quality Specialist
CK Group are recruiting for an External Quality Specialist to join a company in the Pharmaceutical industry at their site based in Ballydine on a contract basis for 11 months and has an hourly rate from €24.61.
The Company: Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. This position sits within their Manufacturing Division, which consists of a team of dedicated, energetic individuals, committed to being the most trusted supplier of pharmaceuticals and health products worldwide. They have an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Location: This role will be working at the Ballydine site which exports to more than 30 countries, including Japan, the US and much of Europe. It produces active pharmaceutical ingredients (APIs) for use by subsidiaries throughout the world, including late stage clinical APIs. The site includes a formulation, R&D and manufacturing facility, which supports our clients initiative to bring new medicines to market more effectively. It develops innovative ways to formulate new products from pilot to commercial scale, and supplies tablets for late stage clinical trials, launch and early stage supply.
The Role: You will be responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analysed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements.
- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures.
- Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings.
- Assist in the coordination of any product recall involving the external manufacturer.
- Provide guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted.
- Working experience within QA in pharmaceutical environment.
- Knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
- Thorough knowledge of all aspects of EM management, supply chain, and operations.
- Experience in SAP and Trackwise.
For more information or to apply for this External Quality Specialist position, please contact Natasha on 44 1438 870011 or email email@example.com, quoting job ref 47983.
It is essential that applicants hold entitlement to work in Ireland.