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Job Description
Experienced QA Specialist sought for a rapidly growing biopharmaceutical manufacturer in Carlow, responsible for ensuring manufacturing compliance with cGMP and regulatory requirements.
We are currently looking for an experienced QA Specialist for an exciting role with a rapidly growing biopharmaceutical manufacturer based in Carlow. You will be responsible for ensuring manufacturing of drug products are complaint with cGMP and associated regulatory requirements. If you have a third level degree along with 3-5 years experience in pharmaceutical manufacturing including Quality and GMP auditing this could be the role for you.
- Review of batch documentation, SOPs, Cleaning verification and validation data
- Support development and implantation of improved quality documentation and procedure
- Provide real time shop floor support for daily manufacturing operations
- Quality input into shop floor decision making
- Provide training in all aspects of QMS and GMP
- Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis
- Be an advocate of continuous improvement in the Quality Management Systems
- Actively participate in Plant/Quality committees and works with other site functional groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives
- Contribute to continuous improvement initiatives and ensure the department maintains inspection readiness
- Maintain self inspection program and continuously monitor quality systems
Requirements:
- Third Level Degree qualified in a Science/Technical or related discipline
- Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment
- Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site
- GMP Audit experience in the pharmaceutical industry