Quality Assurance Specialist
3 weeks ago
QA Associate Specialist - Shift
RK22685
Contract – 11 months
On site - Carlow
We're currently recruiting for an exciting opportunity with a multinational Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational at an exciting growth period.
Duties
- Responsible for ensuring manufacturing of drug products is in compliance with cGMP and associated regulatory requirements.
- Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
- Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to customers.
- Review and approval of batch documentation, SOPs, cleaning verification and validation data, training and other QMS documentation.
- Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
- Provide quality oversight including training on all aspects of QMS and GMP and provide quality support for day to day operations.
- Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic operations.
- Participate in Plant/Quality committees to help set the direction for plant wide GMP initiatives.
Education & Experience
- Third Level Degree qualified in a Science/Technical or related discipline.
- GMP audit experience in pharmaceutical industry.
- 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.
- Report, standards, policy writing skills required.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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