- Reference: GY46708
- Job Type: Contract
- Location: Galway
- Category: Science, Pharmaceutical & Food
The Analytical Quality Specialist provides performs a variety of QA review/approval functions and provide quality assurance for the Operations Analytical and Product Release areas to ensure compliance to internal procedures and external regulatory standards.
- Provides quality assurance support and direction to the analytical laboratory responsible for the testing and release of all drug combination products and raw materials used on the site.
- Responsible for ensuring that Raw Materials, Finished Goods, non-routine and Stability testing is carried out in accordance with cGMP both in BSC laboratories and at the contract laboratories.
- The QA Specialist shall provide support and guidance in the areas of cGMP, Compliance, Regulatory, and Technical Investigation.
- The role also requires working with the cross functional groups including Product Release, Supply Chain Planning, Shipping and Distribution groups.
Education/Qualifications & Experience:
- Level 8 Qualification in science or related engineering discipline. Minimum of 3-5years in a similar role.
- Experience working in the pharmaceutical or biotechnology industry is essential.
- Excellent written and verbal communication skills.
- Experience working with dynamic cross functional teams and prove abilities in decision making.
- Strong organisational skills including ability to follow assignments through to completion.
- Detailed knowledge of applicable regulatory requirements.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com