LSC have a great contract opportunity for a Tech Transfer Lead (Junior) to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have a third level bachelor's degree in Science or Engineering with 3-5 years' experience in a similar role and are ready for your next challenge, this could be the perfect project for you!
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Provides recommendations to management during investigations. Provide support to the and be a link to manufacturing on key investigations as a process expert.
- Development of validation plans, process performance qualifications (PPQs) 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).
- Participate in validation cross functional teams at the site to ensure adherence to required policies and procedures.
- Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills
- Knowledge of Quality systems, Drug Product Manufacturing and Validation.
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 Peter Cronin at +353 214771329 if you have any more questions about this opportunity!
