ASSOCIATE SPECIALIST, QUALITY ASSURANCE

11 month contract position on 2 cycle shift. 20% shift premium.
Responsible for ensuring that the process for the manufacture of drug product at the Carlow site is in compliance with cGMP and the associated regulatory requirements. Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.

SKILLS AND KNOWLEDGE

• Third Level Degree qualified in a Science/Technical or related discipline.
• 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.
• GMP Audit experience in the pharmaceutical industry
• Problem-solving / critical thinking - ability to understand connections between different technical/quality system areas and recognize potential compliance issues and trends.
• Communication, decision making, people influencing, and project management skills will be important.
• Report, standards, policy writing skills required.
• Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.