Audit à Singapour

Overview*

NCIS is establishing a new Stem Cell Therapy Hub (SCTH) as part of expansion of its Specialized Programmes and to become a Reference Centre of Excellence. We are looking for a Quality Control (QC) Specialist for the QC department in the organization.

The candidate will execute the assigned Quality Control Testing (e.g. Raw Material Testing, In-process testing, Final Product Testing, Analytical Science and Technology, Environmental and QC Systems, for NCIS Specialized Programmes (specifically Cellular Therapy and Haematopoietic Stem Cell Transplant) and other provided services.

Job Responsibilities*

• Responsible for routine testing which includes analytical, bioanalytical, microbiological and/or environmental samples testing, depending on the technical role assigned.

• Coordinating and scheduling of testing activities.

• Ensure all critical materials, reagents and consumables required for testing are available.

• Coordinate procurement and provide URS of materials for QC usage which includes consumables, reagents, test media, test cultures, small equipment, glassware, plasticware etc.

• Coordinate shipment of samples and QC materials.

• Ensure all laboratory operations including test execution, review and data documentation are performed according to cGMP procedures.

• Participate in creating SOP, reviewing SOP, equipment qualification and method verification/validation activities.

• Coordinate/Perform calibration and preventive maintenance of laboratory equipment

• Initiate quality document such as out of specification investigation, deviation record, change control etc if necessary.

• Support in the timely resolution of issues, including discrepancies, investigations and implementation of CAPAs.

• To support supervisor/manager in reviewing protocols/reports/SOPs and other documents assigned by the supervisor/manager.

• Participate in method validation/method verification activities which include protocols preparation and review.

• Perform trend analysis of test data that are essential for monitoring purpose.

• To conduct training as subject matter expert in the test methods, systems and equipment assigned.

• Supports improvement initiatives, programs and projects driven from the Quality Management System

• Support as subject matter expert during internal and external audits/inspections.

• Escalates quality and compliance risks to QC Management and QA.

• Any other responsibilities assigned by the QC Management

• Note: Other responsibilities may be assigned.

Requirements*

• Bachelor or higher, in Science, Pharmacy, Pharmaceutical Science, or equivalent, with preference of more than 2-4 years of relevant work experience in Quality Control role in the pharmaceutical/biotechnology/medical device/healthcare industry.

• Good knowledge of quality control, quality management system and validations requirement, preferably with third party customer/supplier or vendor management experience.

• Good knowledge in regulations and industrial guidance especially for stem cell / cell and gene therapy

• Good communication and able to engage stakeholders effectively from different functional units

• Critical thinking and problem-solving skill are of advantage.