QA Systems and Processes Lead

1 day ago


Dublin, Dublin City, Ireland CPL Full time

Job Overview

CPL in partnership with SK biotek are looking for a QA Systems and Validation Specialist on a 12-month contract to join the team in the Swords Campus.

About Us

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. We are part of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to 'make what matters for a healthy, happier world', from grams to tonnes.

Position Description

The QA Systems and Validation Specialist will be responsible for assessing changes for GMP compliance, reviewing and approving GMP design aspects of major capital projects, and ensuring all quality systems are implemented and executed in compliance with ICH Q7, EudraLex, 21 CFR, and site quality standards.

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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