Job Title: QA Systems and Validation Specialist
(12 month Contract)
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 the wider SK Inc. with revenues of $95 billion in 2020.
Our mission is to 'make what matters for a healthy, happier world', from grams to tonnes.
The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs), Highly Potent Active Pharmaceutical Ingredients and Chemical Intermediates for almost 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.
Current Need
Cpl in partnership with SK biotek Ireland Quality team are looking for a QA Systems & Validation Specialist for a 12 month contract reporting into the Quality Manager.
Position Description
The QA Systems and Validation Specialist will be responsible for:
* Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.
* Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems.
* Ensure all quality systems are implemented/executed in compliance with ICH Q7, Eudralex, 21 CFR and site Quality standards.
The role requires expertise in validation ensuring compliance with current industry regulations, guidelines and trends.
This includes qualification of premises, equipment and utilities, computer system qualification, CSV, laboratory equipment validation, NPIs, and high level interaction with various functions on site.
Knowledge of relevant process validation/cleaning validation/automation is an advantage.
Participate in other projects as directed by the Quality Systems & Validation Manager.
Minimum Requirements
To be successful in this role you will need:
* Min of BSc/BEng in Chemistry, Engineering or a science-related discipline with at least 3 years pharmaceutical experience ideally in a QA role.
* Knowledge/appreciation of other site operations such as QC, Operations, Engineering, IT.
* Some experience in Operational Excellence or project management would be desirable.
You should also have knowledge of relevant regulatory requirements for Data Integrity, including GMPs.