QC Manager Days Role - County Clare
FRS Recruitment are proud to be recruiting on behalf of an International Biotechnology company in the Mid-West who are looking to significantly expand their Quality Control Operations. I am looking to speak to an experienced QC Manager with at least 5 years GMP industry experience. They will be responsible for communicating on behalf of QC, providing strong leadership and coordinating cross site activities. This is a full-time permanent job with full suite of benefits to include Medical Insurance, Life Assurance, Pension, Yearly Bonus.
Responsibilities:
* Provides technical troubleshooting for equipment and methods.
* Ensures site compliance to regulatory standards for QC; ICH, FDA & European regulatory requirements and guidelines.
* Supports the preparation of site inspections and ensures the lab maintains a state of cGMP compliance.
* Develops and manages the site testing schedule to support raw material, plasmid, viral vector and drug product testing requirements.
* Analytical transfer of methods, qualification of compendial methods and validation of analytical methods, all to ICH, EU, FDA standards.
* Drafts, reviews and approves QC SOPs to support testing related activities on the clients site.
* Collaborates with other departments at the clients facility, coordinating activities with them and providing QC support where required.
Desired Skills and Experience:
* 5 years' GMP industry experience.
* B.Sc. Degree in a relevant scientific discipline.
* Understanding of GMP standards for QC validation, testing and related activities (ICH, EU, FDA).
* Strong Collaboration, Communication and Conflict resolution skills.
* Previous leadership experience managing a team within a QC lab.
* Experience in working with gene therapy would eb an advantage e.g. HPLC, Western blot, Capillary Electrophoresis, DNA extraction, Spectrophotometry.
***Min 5 years GMP Industry experience essential along with a degree qualification in a scientific discipline***
For more details and a full job description on this QC Manager Job in Clare, please apply with an updated CV.
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