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
Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives.
The SK pharmteco Small Molecule 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.
Job Summary
We are seeking a QA Validation Lead to join our team on a 12-month contract. The successful candidate will be responsible for leading the qualification of computer systems, ensuring compliance with ALCOA+ Data Integrity and Compliance Assurance, and assessing changes for GMP compliance.
Key Responsibilities
* 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 NPIs.
* Review and approval of the GMP design aspects of major capital projects including Software upgrading, Qualifying /validation Recipes.
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.
Skills
* GMP CSV automation validation