LSC have a great contract opportunity for a Quality Assurance Specialist to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems.
- Review and approval of SOP's, cleaning verification/validation data and other documents as necessary for the IPT department.
- Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same.
- Provide effective real time on the floor support for day-to-day manufacturing operations for example area clearances, batch record reviews, aseptic operations.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering, or other technical discipline
- Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment
- GMP Audit experience in the pharmaceutical industry
- Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Gráinne Hodnett at +353 21 4771 329 if you have any more questions about this opportunity!