Job Description
We are seeking a highly skilled QA Associate Specialist to join our team at a multinational Pharmaceutical organization based in Carlow. This is an excellent opportunity for individuals who want to be part of a leading company during its growth period.
Duties
1. Ensure manufacturing of drug products complies with cGMP and regulatory requirements.
2. Review and approve GMP documentation to support corporate compliance and regulatory expectations for manufacturing operations.
3. Ensure objectives are effectively achieved, consistent with company requirements for compliance, safety, and reliable supply to customers.
4. Review and approval of batch documentation, SOPs, cleaning verification and validation data, training, and other QMS documentation.
5. Liaise with Quality Specialists/QP/QA Lead to resolve queries related to batch manufacturing process.
6. Provide quality oversight, including training on all aspects of QMS and GMP, and provide quality support for day-to-day operations.
7. Provide real-time on-floor support for day-to-day manufacturing operations, such as area clearances, batch record reviews, and aseptic operations.
8. Participate in Plant/Quality committees to set the direction for plant-wide GMP initiatives.
Education and 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, applicable to the site.
* Report, standards, policy writing skills required.