About the Role
:
An amazing opportunity has arisen for a QA Specialist, within our Dundee manufacturing site. The QA Specialist will be to ensure the compliance of materials, products and components (primary and secondary); services related to manufacturing to define regulatory & cGxP frameworks. You'll bring a strong attention to detail, effective communication, excellent organizational and time management skills to support the business.
Key Accountabilities:
1. Disposition of raw materials and packaging and products including the necessary checks of associated documentation and necessary ERP transactions.
2. Involvement in Deviation Management and CAPA system(s).
3. Review, advise and approve effective change control actions across the Dundee Facility ensuring compliance with the necessary regulations.
4. Advise on the investigation of customer complaints.
5. Ensure the sites ongoing FUST Stability programme is met.
6. Write/revise/approve and give advice on GMP documentation
7. Support the Dundee audit platform, for both internal & external audit and ensuring compliance to the annual self-assessment / self-audit platform as defined by the Site Quality team
8. Support the continuous improvement platform for manufacturing, by providing technical support on quality
framework(s) and collaborating across the business to reinforce a progressive quality culture
9. Supports and ensures compliance to Quality owned systems, including but not limited to QPulse & SharePoint.
Qualifications:
10. Bachelor's degree in Science (Chemistry; Pharmacy; Biology) or equivalent experience
Knowledge/Experience:
11. Demonstrated Quality Assurance experience of 1- 3 years, in a regulated Industry, preferably Pharmaceuticals
12. Good knowledge and understanding of cGMP, quality systems and quality practices associated with production, analytical testing and documentation
13. Ability to work with competing priorities and achieve multiple deadlines / timeframes
14. Effective communication, negotiation and influencing skills
15. Ability to work independently and employ the initiative to find solutions, prioritise and exercise discretion
16. Has a proactive and flexible approach to work
17. Strong attention to detail with a record of driving quality performance with a quality focussed attitude