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QA specialist

Real Staffing Group

Posted on Jan 7, 2021 by Real Staffing Group

Cork, Ireland
Immediate Start
Annual Salary

Key Role Activities

  • Prepare, update and approve procedures in accordance with GMP/GDP and company requirements

  • Manage all documents in accordance with records management

  • Assist in the implementation and update of internal or external standards

  • Identify and Log Quality Issues, perform impact assessments and lead investigations

  • Collaborate effectively with various internal and external partners

  • Ensure appropriate management of non-conformances related to GMP and GDP, internal and external change controls and CAPAs.

  • Support the Quality Manager with monitoring and oversight of outsourced activities.

  • Perform allocated internal audits as required

  • Support and participate in local initiatives or projects to increase compliance and reduce costs/non-conformance.

  • Provide the necessary input to the Quality Manager for the bi-annual management review of the Legal Entities.

  • Support the process for intake of medicinal queries and complaints, ensuring timely case processing.

  • Maintains the Wholesale Distribution Authorisation, ensuring compliance with the general conditions detailed, in line with European and local regulations.

  • To ensure compliance with the requirements of Good Distribution Practice (EU GDP).

  • To ensure that all aspects of the quality system are implemented and maintained.

  • Ensure that the quality, safety and traceability of medicinal products are maintained within the supply chain.

  • To ensure appropriate competence and experience as well as knowledge of and training in GDP.

If you are interested in this role and would like to learn more, please respond to this advert, and a member of the team will be in touch.

*Please note, in order to be eligible for this role you must hold an EU passport, or a stamp4 visa*

Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

Reference: 1053689683

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