QA Systems and Validation Specialist
This is a 12 month contract position.
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. Our mission is to 'make what matters for a healthy, happier world', from grams to tonnes.
Job 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.
* They will 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.
* Provide expertise in the area of validation ensuring compliance with current industry regulations, guidelines and trends.
Responsibilities
* Qualification of premises, equipment and utilities.
* Computer system qualification.
* Laboratory equipment validation.
* NPI's.
* High level interaction with the various functions on site: Manufacturing, QC, Utilities and Engineering.
* Knowledge of relevant process Validation / cleaning Validation advantage.
Requirements
* 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.
* Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.
We offer: A unique opportunity to work in a dynamic and innovative environment, contributing to the development of life-changing medicines.