Job Title: Quality Assurance Specialist
Location: Tipperary, Ireland
About the Role:
* Evaluate compliance of batch documentation to standard operating procedures (SOPs), Good Manufacturing Practices (GMPs) and relevant regulations.
* Review and approve production and analytical documentation for drug substance, drug product and packaged finished goods to ensure adherence to SOPs, GMP and regulatory requirements, including QP certification.
* Cultivate strong relationships with functional areas to develop a collaborative working environment and understanding of roles and responsibilities.
* Utilize this network to resolve audit and review comments and issues effectively.
* Manage product recalls and stock recoveries as necessary.
* Identify compliance gaps and propose recommendations for continuous improvement.
* Develop and maintain assigned SOPs.
* Perform and review complaints and deviation investigations, change controls and corrective actions.
* Support the induction process for new starters and training of other staff.
* Ensure all assignments are completed to standards of compliance, efficiency, innovation, accuracy and safety in accordance with company and regulatory requirements.
* Stay up-to-date with cGMP requirements as described in applicable worldwide regulations.
* Represent the department on cross-functional teams.
* Assist in generating, reviewing and approving Technical & Quality Agreements.
Requirements:
* Bachelor's degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience.
* 3 years of relevant post-degree experience in a GMP environment.