LSC have a great contract opportunity for a Quality Engineer 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.
If you have proven track-record in delivering results in a world-class supply organization are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
* Support Engineering activities through documentation generation, equipment and process investigations associated with GMP activities and completion of quality notifications.
* Be a document system expert; this will include document review, approval and document system workflow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls.
* Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g., FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system.
* Required to comply with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
* Support and lead Internal Quality audits of Engineering Dept.
* Assist in the management and/or assignment of Engineering training if required
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering, or other Technical discipline
- Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting
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 contactPawel Jurkiewiczl at +353 21 471 8208 if you have any more questions about this opportunity!