LSC have a great contract opportunity for a Quality Control Micro Analyst to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
If you have minimum of 1 year experience in cGMP Quality environment and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES
- Environmental and Facilities monitoring sampling and testing.
- Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
- Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system and Identification system.
- Represent the Microbiology department in internal and external audits where appropriate.
- Close out of actions/ recommendations identified from both internal and external audits.
- Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
- Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
- Technical competency in Sterility Assurance, Aseptic filling, and microbiology methods.
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!
Call Alison Jones in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert