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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Quality Assurance Specialist


Reference:AMC21988 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist


QA Specialist
On Site - Carlow
Shift role
AMC21988

We are currently looking for an experienced QA Specialist for an exciting role with a rapidly growing biopharmaceutical manufacturer based in Carlow. You will be responsible for ensuring manufacturing of drug products are complaint with cGMP and associated regulatory requirements.

If you have a third level degree along with 3-5 years experience in pharmaceutical manufacturing including Quality and GMP auditing this could be the role for you.

Responsibilities

    • Review of batch documentation, SOPs, Cleaning verification and validation data
    • Support development and implantation of improved quality documentation and procedure
    • Provide real time shop floor support for daily manufacturing operations
    • Quality input into shop floor decision making
    • Provide training in all aspects of QMS and GMP
    • Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems.
    • Actively participate in Plant/Quality committees and works with other site functional groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
    • Contribute to continuous improvement initiatives and ensure the department maintains inspection readiness
    • Maintain self inspection program and continuously monitor quality systems

Requirements
  • 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

If you are interested in this posting apply today and Angela from Life Science Recruitment will be in touch!