Analytical Quality Specialist - Galway

Collins Mcnicholas Recruitment

Galway

TheAnalytical QualitySpecialist 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. Responsibilities: 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: amy.oneill@collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.

2183 days ago