QA Specialist| Pharmaceutical| Hybrid working|Perm|Westmeath
Great opportunity for an experienced QA Specialist to join a dynamic and growing Pharma company based in Athlone, County Westmeath. The QA Specialist will take ownership of the company QMS and will report directly to the QA/QP Director onsite. The role will also offer a great opportunity for involvement in new projects and product launches into the European market. The role is hybrid working 3 days onsite and 2 days working from home.
Quality Assurance Specialist responsibilities;
- Maintain Quality Management System processes in line with company procedures and cGMP for activities on-site (Batch Certification, Storage and Distribution)
- Provide quality support and oversight for manufacturing activities conducted at third-party sites.
- Review and approval of Change Control requests, Deviations, Complaints and CAPA’s to ensure compliance with all applicable requirements
- Lead and manage investigations and root cause identification for on-site deviations
- Management of internal and external audits
- Lead and manage third party and vendor qualification activities
- Participate in interdepartmental initiatives for continuous improvement of procedures, processes and systems
- Provide quality support to product launches in new markets
Quality Assurance Specialist Requirements
- Relevant Bachelor’s degree (or equivalent) in a scientific discipline
- Minimum of 5 years’ experience within a pharmaceutical manufacturing environment, Quality Assurance role is essential
- In-depth knowledge of EU/US quality-related pharmaceutical regulations
- Strong working knowledge of EU Regulations (USP, ICH, EU GMPs, FDA etc.)
- Experience in conducting vendor audits
- Working knowledge of EU/US validation requirements
**FULL SPEC ON APPLICATION**
For a confidential discussion and more information on the role, please contact Tina Cornally.