Job Description:
We are seeking a highly motivated QA Associate Specialist to join our team at our Carlow site. This is an exciting opportunity to work with a multinational Pharmaceutical organization during a period of significant growth.
Duties:
* Ensure manufacturing of drug products complies with cGMP and regulatory requirements.
* Review and approve GMP documentation for corporate compliance and regulatory expectations.
* Achieve objectives consistent with company requirements, ensuring 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 on batch manufacturing process.
* Provide quality oversight, including training on QMS and GMP, and support day-to-day operations.
* Offer real-time support for day-to-day manufacturing operations, such as area clearances, batch record reviews, and aseptic operations.
* Participate in Plant/Quality committees to set direction for plant-wide GMP initiatives.
Education & Experience:
* Bachelor's Degree in Science/Technical or related field.
* GMP audit experience in pharmaceutical industry.
* Relevant experience in quality role, ideally in pharmaceutical manufacturing environment.
* Knowledge of US and European cGMP guidelines, and other international regulatory requirements.
* Report, standards, policy writing skills required.