**Job Title:** QA Associate Specialist
Summary
This is an exciting opportunity to join a leading multinational pharmaceutical organization at an exciting growth period. The ideal candidate will be responsible for ensuring manufacturing of drug products is in compliance with cGMP and associated regulatory requirements.
Key Responsibilities:
* 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.
* Participate in Plant/Quality committees to help set the direction for plant-wide GMP initiatives.
Requirements:
* 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.
Skills:
* Quality Assurance
* GMP Auditing