QA Specialist
On Site - Carlow
Shift role
AMC21988

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.

Responsibilities

• 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

• 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