Job Title: QA Validation Lead
Cpl in partnership with The SK pharmteco Small Molecule facility located in Swords, Co Dublin, are looking for a QA Validation Lead to join the team on a 12-month contract.
About Us
SK pharmteco 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 SK Inc., a Korea company with revenues of $99 billion in 2023. Our mission is to 'produce and deliver life-changing therapies that improve patient outcomes and save lives'.
The SK pharmteco Small Molecule, Europe, facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up, and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years.
Current Need:
* Qualification of Computer system qualification.
* Familiar with ALCOA+ Data Integrity and Compliance Assurance.
* Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab, and manufacturing equipment and control system changes.
* Laboratory equipment validation and NPI's.
* Review and approval of the GMP design aspects of major capital projects including Software upgrading, Qualifying/validation Recipes.
* Ensure all quality systems are implemented/executed in compliance with ICH Q7, EudraLex, 21 CFR, and site Quality standards.
* Knowledge on GMP guide, Annex 11, QMS, LIMS, and EBR.
* Provide expertise in the area of validation ensuring compliance with current industry regulations, guidelines, and trends.
Responsibilities:
* Review master and complete qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
* Participate in other projects as directed by the Quality Systems & Validation Manager.
Requirements:
* Min of BSc/BEng in Computer application/Engineering or a science-related discipline with at least 4-5 years pharmaceutical experience ideally in a CSV role.
* Must have experience leading projects with a small team (1-2 people).
* Preferably with experience in change control/documentation management, good manufacturing practices.
* Knowledge/appreciation of other site operations such as QC, Operations, Engineering, IT.