LSC have a great contract opportunity for Tech Transfer Lead to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Development of validation plans, process performance qualifications for vial and syringe filling.
- Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
- Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
- Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
- Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Third level bachelor's degree in science, engineering or a relevant quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills.
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 Cathal Rourke at +353 214771329 if you have any more questions about this opportunity!