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Senior Medical Laboratory Scientist
1 month ago
NCIS is establishing a new StemCell Therapy Hub (SCTH) as part of expansion of its SpecialisedProgrammes and to become a Reference Centre of Excellence. We arelooking for a Quality Control (QC) Team Lead for the QC departmentin the organisation.
The candidate will beresponsible to oversee the Quality Control designated functionwhich can include these areas - Raw Material Testing, In-processtesting, Final Product Testing, Analytical Science and Technology,Environmental and QC Systems, for NCIS Specialised Programmes(specifically Cellular Therapy and Haematopoietic Stem CellTransplant) and other provided services.
JobResponsibilities*
- Responsible tolead and direct the assigned Quality Control designatedfunction.
- As Subject Matter Expert in assignedQC systems/processes/equipment to oversee the implementation andmanagement of systems/processes.
- Owns QCrelated polices and procedure of the assigned QC processes whichinclude product testing, materials testing, environmentalmonitoring, method development/qualification/validation, labinvestigations, stability testing, LIMS, lab equipmentqualification and/or calibration.
- Ensuretimely completion of assigned activities which include testing,method development/qualification/validation, equipmentqualification or computer systems validation as per agreedlead-time/milestones.
- Initiates/Reviews/approves procedures, documents,records, deviations, investigations, corrective action/preventiveactions, changes controls and gaps assessment associated with theQC area(s) assigned.
- Ensure QC personnel arequalified and trained to perform assigned tasks.
- Support product/materials testing, methodsqualification/validation activities, equipment qualificationactivities or other QC related activities as an executor, reviewerand/or approver.
- Ensure products are testedand assessed per applicable current GxP and regulations.
- Ensures that facilities, equipment, materials, processesand procedures that are applicable to QC comply to applicable,current GxP and regulations.
- Manageperformance and development of direct reports to ensure achievementof organizational goals.
- Supports improvementinitiatives, programs and projects driven from the QualityManagement System.
- Escalates quality andcompliance risks to QC and QAManagement.
Note: Otherresponsibilities may be assigned by Head of Quality, or seniormanagement
Requirements
- Bachelor or higher, in Science, Pharmacy, PharmaceuticalScience, or equivalent, with preference of more than 6 years ofrelevant work experience in Quality Assurance Lead role in thepharmaceutical/biotechnology/medical device/healthcare industry,preferable with increasing people managementresponsibilities.
- Extensive knowledge inQuality Management System concepts
- Extensiveknowledge in regulations and industrial guidance especially forstem cell / cell and gene therapy
- Excellentcommunication and able to engage stakeholders effectively fromdifferent functional units
- Critical thinkingand problem-solving skill are ofadvantage.
