Job Title: QA Associate Specialist - Shift
We are 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 and Responsibilities
We are seeking a highly skilled QA Associate Specialist to join our team. The successful candidate will be responsible for ensuring the manufacturing of drug products is in compliance with cGMP and associated regulatory requirements.
* Review and approve 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, such as area clearances, batch record reviews, aseptic operations.
* Participate in Plant/Quality committees to help set the direction for plant-wide GMP initiatives.
Education and Experience
To be considered for this role, you should have:
* A third-level degree qualification 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.