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Dublin, Dublin City, Ireland Cpl Healthcare Full timeJob Description We are seeking a skilled QA Validation Lead to join our team at SK pharmteco in Swords, Co Dublin. As a QA Validation Lead, you will be responsible for the qualification of computer systems, ensuring compliance with ALCOA+ Data Integrity and Compliance Assurance standards. This role involves assessing changes for GMP compliance in accordance...
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Qa Validation Lead
2 weeks ago
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.
Review master and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.Knowledge on Risk-Based Validation for IQ/OQ/PQ.Participate in other projects as directed by the Quality Systems & Validation Manager.High level interaction with the various functions on site: Manufacturing, QC, Utilities and Engineering.Minimum 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.Some experience in Operational Excellence or project management would be desirable.Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.The QA Validation lead must possess strong initiative and be capable of working both independently and collaboratively across organisation.Strong interpersonal, communication and presentation skills are required for this position as well as good time management, multi-tasking and organisational skills.
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