We are working in partnership with our client based in the Midlands. We have a new opening for a Quality Specialist to join an established and leading Global Pharmaceutical company on site in Co. Westmeath.
This is a permanent role with an attractive package on offer for the successful candidate.
- Certify medicinal products in accordance with requirements of product marketing authorisation, EU Directives, EU Annex 16, and Annex 13 where applicable for Investigational Medicinal Products, and in accordance with appropriate US and other territory regulations.
- Assist in the coordination of the QA operational duties related to product disposition.
- Review Change Controls/SOPs and related documentation for compliance with Regulatory approvals and GMP and site requirements.
- Ensure product release procedures comply with current regulatory and company requirements.
- Review and approve validation/qualification documents.
- Application of revised Pharmaceutical Regulations.
- Ensure adherence to the best health and safety standards.
- Proficient in the use of the Quality Systems in operation in the Organisation.
- Minimum 3 Years of Experience in a QA/QC role in the Pharmaceutical Industry.
- Third Level Qualification (BSc or Higher) in Pharmaceutical Manufacturing Technology.
- Excellent written and oral communication skills.
- Proven track record in your current role is essential.
- Responds positively to changing circumstances and priorities
If you would like more information on this role you can contact Paul Dunican
(090) 641 7022