Job Title: QA Associate Specialist - Shift
We are seeking a highly motivated and detail-oriented QA Associate Specialist to join our team in Carlow, Ireland. This is an exciting opportunity for a professional looking to contribute to the success of a leading multinational pharmaceutical organization.
Duties:
* Ensure manufacturing of drug products complies with cGMP and associated regulatory requirements.
* Review and approve GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
* Ensure 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 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, such as area clearances, batch record reviews and 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 the 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.
Description:
This QA Associate Specialist role will play a critical part in ensuring the high-quality production of drug products at our Carlow site. The successful candidate will have excellent attention to detail, strong communication skills and the ability to work collaboratively as part of a cross-functional team.
The ideal candidate will have a Third Level Degree in a Science/Technical or related discipline, along with relevant experience in a quality role within the pharmaceutical industry. A background in GMP audits and knowledge of US and European cGMP guidelines will also be advantageous.
We offer a competitive compensation package and opportunities for career growth and development in a dynamic and supportive environment.