GMP Compliance and Validation Expert

4 days ago


Dublin, Dublin City, Ireland CPL Full time

About the Company

SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France, and Ireland. Our mission is to 'make what matters for a healthy, happier world', from grams to tonnes.

The Opportunity

We are seeking a QA Systems and Validation Specialist to join our team at the Swords Campus. This is a 12-month contract opportunity reporting directly to the Quality Manager.

Responsibilities

  • Assess changes for GMP compliance in accordance with site change control procedures for facilities, utilities, lab, and manufacturing equipment and control system changes.
  • Review and approve GMP design aspects of major capital projects, including new facility construction, facilities upgrade, new manufacturing equipment, and support systems.
  • Ensure all quality systems are implemented and executed in compliance with ICH Q7, EudraLex, 21 CFR, and site quality standards.
  • Provide expertise in validation ensuring compliance with current industry regulations, guidelines, and trends. Review master and completed qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
  • Qualify premises, equipment, and utilities.
  • Computer system qualification, CSV.
  • Laboratory equipment validation.
  • NPIs.
  • High-level interaction with various functions on-site: Manufacturing, QC, Utilities, and Engineering.

Requirements

  • A minimum of a BSc/BEng in Chemistry, Engineering, or a science-related discipline with at least 3 years of pharmaceutical experience ideally in a QA role. Preferably with experience in change control/documentation management, good manufacturing practices.
  • Knowledge/appreciation of other site operations such as QC, Operations, Engineering, IT.
  • Some experience in Operational Excellence or project management would be desirable.
  • Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.


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