LSC have a great contract opportunity for a QC 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 1+ years of experience working in the biochemistry, pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Ensuring high cGMP, GLP standards are maintained while reviewing and adherence to schedules and targets to meet regulatory and business requirements.
- 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.
- To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.
- Perform technical review of data generated in laboratory, validation protocols and reports.
- Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree in Microbiology or related science.
- Minimum of 1 year experience in cGMP Quality environment.
- Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
- Experience in Data Review in a GMP Quality Environment (preferred).
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 Kathy Gillen at LSC on 021 4777329 if you have any more questions about this role!
