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QA Validation Lead
1 month ago
Location: Swords, Co Dublin
Contract: 12 months
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. With a talented workforce, exceptional technical capabilities and facilities, we have made some of the world's most important medicines and continue to do so. Further information on SK pharmteco can be found at www.skpharmteco.com.
Current Need
We are looking for a QA Validation Lead who will be responsible for:
1. Qualification of Computer system qualification.
2. Familiarity with ALCOA+ Data Integrity and Compliance Assurance.
3. Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.
4. Laboratory equipment validation and NPI's.
5. Review and approval of the GMP design aspects of major capital projects including Software upgrading and Qualifying/validation Recipes.
6. Ensure all quality systems are implemented/executed in compliance with ICH Q7, EudraLex, 21 CFR and site Quality standards.
7. Knowledge of GMP guide, Annex 11, QMS, LIMS, and EBR.
8. 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.
9. Knowledge of Risk-Based Validation for IQ/OQ/PQ.
10. Participate in other projects as directed by the Quality Systems & Validation Manager.
11. High level interaction with the various functions on site: Manufacturing, QC, Utilities, and Engineering.
Minimum Requirements
1. 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.
2. Must have experience leading projects with a small team (1-2 people).
3. Preferably with experience in change control/documentation management, good manufacturing practices.
4. Knowledge/appreciation of other site operations such as QC, Operations, Engineering, IT.
5. Some experience in Operational Excellence or project management would be desirable.
6. Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.
7. The QA Validation lead must possess strong initiative and be capable of working both independently and collaboratively across the organisation.
8. 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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