Quality Assurance Specialist

1 day ago


Dublin, Dublin City, Ireland Recruitment by Aphex Group Full time

Job Overview:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Recruitment by Aphex Group. As a key member of our site Quality Assurance team, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.

About the Role:

  • Perform routine quality assurance duties, including review and approval of Standard Operating Procedures (SOPs) and batch records.
  • Provide quality support for triage and investigation of non-conformance events, including deviations and customer complaints.
  • Collaborate with cross-functional teams to identify and implement continuous improvement initiatives.
  • Ensure compliance with relevant regulatory requirements, including cGMP regulations.
  • Develop and maintain training programs to ensure staff understanding of quality procedures and protocols.
  • Oversight of production unit operations, extending to formulation, vial and Syringe Fill Finish related activities.
  • Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.

Requirements:

  • University degree in a scientific or engineering discipline preferred.
  • Relevant experience (4 yrs +) working in the pharmaceutical industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  • Preferable Experience in Sterile drug product Fill finish site with a Quality Assurance or Quality Control background.
  • 2 -3 Years Minimum GMP Pharmaceutical experience working within Ireland if possible (or if experience is outside Ireland must be a well-known Pharma Multinational).Excellent written and verbal communication skills.
  • Experience working with dynamic cross-functional teams and proven abilities in decision making.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
  • Experience working in aseptic operations, protein formulation, vial and syringe filling.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.


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