Job Summary
This role shall report to the Biosafety & Cell Based Assay Supervisor and the main duties & responsibilities shall be to assist the Department Manager and/or the Scientist in the following:
* Leading the execution of routine cell-based potency assays
* Support technical transfer, qualification and validation of new cell-based assays
* Maintenance and propagation of antibiotic free cell cultures.
* Evaluation of mammalian cells / Generation and maintenance of mammalian cell banks.
* Establishment of Test Method SOPs and validation of methods
Core duties shall include:
* Maintenance and propagation of antibiotic free cell cultures.
* Competent in microscopic evaluation of mammalian cells (e.g. cell morphology, count and viability)
* Provide technical training to team as required.
* Receipt and processing of test samples in LIMS.
* Update current standard operating procedures.
* Assist in laboratory investigations where necessary.
* Responsible for reporting progress information to Management.
* Assist in internal, regulatory and client visits/audits and respond to findings.
* Complete understanding off all regulatory guidelines.
* Liaise with the Quality Department for the generation of all departmental quality documents including audit responses, facility replies and deviation reports.
* Generation of GMP compliant SOPs, Protocols and reports
* Generate risk assessments for laboratory and test items as required.
* Maintain Laboratory Data Integrity and compliance
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