Quality Assurance Specialist Role
We are seeking a Quality Assurance Specialist to join our team in Carlow. As a Quality Assurance Specialist, you will play a vital role in ensuring the maintenance of cGMP standards across our production teams.
Key Responsibilities:
* Provide quality support to IPT production teams to ensure compliance with cGMP regulations.
* Understand and apply sterile manufacturing operations principles.
* Utilize computerized systems for daily performance of tasks.
* Prioritize, manage multiple tasks, and meet deadlines.
* Perform timely reviews on batch documentation and assist in resolving concerns commensurate with risk.
* Liaise with department representatives to promote improvements in GMP and quality standards.
* Stay up-to-date with the latest developments from regulatory authorities related to quality compliance activities.
* Comply with current Manufacturing Division, Quality, and EHS Management System requirements as relevant to commercial operations.
Requirements:
* Degree qualification in Science, Quality, or Technical field.
* At least 2 years' experience in Quality Assurance, Quality Control, or Technical Operations within the Biological and/or pharmaceutical industry.
* Experience in Sterile Manufacturing.
* Operational experience of quality systems in a dynamic manufacturing environment.
* Sterile filling processes and equipment and support services experience.
* Lean Six Sigma Methodology experience desired.
About This Opportunity:
This is an excellent opportunity for anyone looking to join a leading multinational organization in the pharmaceutical industry.