Our client, a leading centre of excellence in biologics development, is currently seeking to hire a QC Technical Support (Microbiology & Environmental Monitoring).
The incumbent of this role will provide support the activities of the company's new GMP Quality Control Laboratories and associated infrastructure. Reporting to the Head of Quality, this role will help ensure that the new Manufacturing Centre meets the standards and expectations of its key stakeholders; regulatory authorities; and potential collaborators.
- QC Lab Support
- Conducting environmental monitoring / microbiology raw material, in-process, final product & sterility testing
- Review and reporting of process trending charts
- QC Sample Management & LIMS Management
- Support the Sample Management function to ensure the QC group provides a timely, effective and efficient service for the collection
- Support the implementation of a suitable electronic laboratory information management system (LIMS)
- Support microbiology test validations and method qualifications.
- Provide support for aseptic process qualifications, such as aseptic gowning, good aseptic practises and media fills etc.
- Support microbiological Out of Specification investigations.
- Regulatory Compliance
- Support to ensure all QC laboratory equipment is maintained fit for purpose (qualified and calibrated appropriately and with the appropriate degree of periodicity).
- Generate, review and approve cGMP documentation such as Standard Operating Procedures, Analytical Test Methods, Analytical Test Qualification protocols and reports etc.
- Participate in Out of Trend, Out of Specification and Deviation management events associated with QC activity and assist in the reporting and management of such events to an appropriate and compliant conclusion.
The ideal candidate will be able to demonstrate the following minimum criteria:
- Experience working in microbiology or in an aseptic (bio)pharmaceutical manufacturing environment.
- Experience of writing and reviewing GMP documents.
- Experience of looking critically at own and others work practices and procedures and identifying and implementing any needed improvements
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nisha Patel on +44 203 8618 210 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.