About SK pharmteco
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 Korean company with revenues of $99 billion.
Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives.
Job Description
We are looking for a QA Validation Lead who will be responsible for:
* Qualification of Computer systems and equipment
* Familiarity with ALCOA+ Data Integrity and Compliance Assurance
* Assessment of changes for GMP compliance in accordance with site change control procedure
* Laboratory equipment validation and NPI's
* Review and approval of the GMP design aspects of major capital projects
* Ensuring all quality systems are implemented/executed in compliance with ICH Q7, EudraLex, 21 CFR and site Quality standards
The QA Validation Lead must possess strong initiative and be capable of working both independently and collaboratively across the organisation.
Requirements
* BSc/BEng in Computer application/Engineering or a science-related discipline with at least 4-5 years pharmaceutical experience
* Experience leading projects with a small team
* Knowledge/appreciation of other site operations such as QC, Operations, Engineering, IT
* Regulatory requirements for Data Integrity, including GMPs
About the Facility
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.