LSC have a great contract opportunity for a QC Micro Specialist to join a biopharmaceutical company based in Westmeath. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have a Bachelor's Degree in Microbiology or related Science and 5 years experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Supporting and coordinating validation/Qualification of Microbiology test methods
- Generation of annual environmental monitoring reports
- Lead and participate Quality Risk Assessments relating to the Microbiology.
- Maintain regulatory compliance through the creation and maintenance of programs for laboratory testing, training, SOPs and validation.
- Preparation of documentation for audits carried out by internal auditors and Regulatory bodies.
- To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A high degree of technical competency in Sterility Assurance, Aseptic filling, and microbiology methods.
- Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
- Subject Matter Expert in Method Validation, Endotoxin and Bioburden testing
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 021-4777329 if you have anymore questions about this opportunity!