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QA Systems and Validation Specialist
1 month ago
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QA Systems and Validation Specialist, DublinClient: Cpl
Location: Dublin, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 35226f290646
Job Views: 2
Posted: 27.04.2025
Expiry Date: 11.06.2025
Job Description:Cpl in partnership with SK pharmteco are looking to hire a QA Systems and Validation Specialist on a 12-month contract at the Swords Campus.
About Us
SK pharmteco, a global Contract Development and Manufacturing Organisation (CDMO), operates state-of-the-art facilities in Korea, US, France, and Ireland. Part of SK Inc., with revenues of $95 billion, our mission is to 'make what matters for a healthy, happier world', from grams to tonnes. The Swords Campus has a 60-year history in developing, scaling-up, and manufacturing Active Pharmaceutical Ingredients (APIs), Highly Potent APIs, and Chemical Intermediates. We are committed to producing some of the world's most important medicines with a talented workforce and advanced facilities. More information can be found at.
Current Need
Cpl, in partnership with SK pharmteco Ireland, is seeking a QA Systems & Validation Specialist for a 12-month contract reporting to the Quality Manager.
Position Description
The QA Systems and Validation Specialist will be responsible for:
- Assessing changes for GMP compliance according to site change control procedures for facilities, utilities, lab, manufacturing equipment, and control system changes.
- Reviewing and approving GMP design aspects of major capital projects, including new facilities, upgrades, new equipment, and support systems.
- Ensuring all quality systems comply with ICH Q7, EudraLex, 21 CFR, and site standards.
- Providing expertise in validation to ensure compliance with industry regulations, reviewing qualification and validation protocols, reports, and data for conformance.
- Qualification of premises, equipment, and utilities.
- Interacting with manufacturing, QC, utilities, and engineering teams.
- Knowledge of process validation, cleaning validation, and automation is advantageous.
- Participating in other projects as directed by the Quality Systems & Validation Manager.
- Demonstrating strong communication, presentation, time management, multitasking, and organizational skills.
Qualifications:
- BSc/BEng in Chemistry, Engineering, or a science-related field with at least 3 years of pharmaceutical experience, preferably in QA.
- Experience with change control, documentation management, and GMP practices.
- Knowledge of site operations such as QC, operations, engineering, and IT.
- Operational excellence or project management experience is desirable.
- Knowledge of regulatory requirements related to Data Integrity and GMPs.
