Job Description
A Quality Specialist is required by CareerWise Recruitment for our Dublin West based pharmaceutical client. This is a 4-month contracting position. If you have experience in the Pharmaceutical industry then this is the position for you
Role of this position
1. Support the Quality Manager and Qualified Person in maintaining compliance with Good Manufacturing Practice (GMP), for Medicinal Products, Quality Systems, local and corporate procedures, regulatory requirements, and industry standards.
2. Assist the Quality Manager and Qualified Person in the development of continuous improvement and compliance projects within the Quality Department. For example - Support projects as the business expands within the compounding services division
3. Review and co-ordinate any CAPA investigations for deviations at the site which may impact on product quality for products supplied to the client.
4. Co-ordinate customer and supplier complaints - including investigations, reporting, and trending. Ensure the management of the SAP disposition of non-conforming products.
5. Defining and periodically updating Quality Procedures in conjunction with operating staff, while ensuring compliance with GMP and GDP.
6. Prepare information in advance for presentation at the Quality Review Board meetings.
7. Assist in the completion of internal audits of GMP systems, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken.
8. Assist the Quality Manager in maintaining copies of the approved Specifications in the Document Management system and ensuring the relevant personnel are included in the distribution list
9. Recording, investigating and reporting incidents and deviations to the Quality Manager and Qualified Person.
10. Assisting Process Owners in assessing risks and assigning counteractive measures.
11. Documenting and managing relevant change controls through to completion.
12. Ensure the adherence to the stability schedule.
13. Management of the stability data for the support of the expiry dates.
14. Assist in the co-ordination and documentation of product recalls and mock recalls.
15. Support Pharmacovigilance and Compliance activities as required.
16. Responsible for issuing protocol and report numbers and maintaining associated logs.
JOB REQUIREMENTS
17. Bachelor's degree or higher; ideally in a related Science discipline
18. Demonstrated ability in quality systems support
19. Knowledge of EU quality related pharmaceutical regulations
20. Experience in compounding and working in a MIA environment
21. Knowledge of Industry Best Practices for quality and compliance related topics
22. SAP experience.
23. The ideal candidate will have 3- 5 years' experience in a pharmaceutical/regulated background with strong working knowledge of compounding, GMP and regulatory expectations.