Medical Laboratory jobs in Malaysia

Overview

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

The candidate will be responsible to oversee the Quality Control designated function which can include these areas - Raw Material Testing, In-process testing, Final Product Testing, Analytical Science and Technology, Environmental and QC Systems, for NCIS Specialised Programmes (specifically Cellular Therapy and Haematopoietic Stem Cell Transplant) and other provided services.

Job Responsibilities*

• Responsible to lead and direct the assigned Quality Control designated function.
• As Subject Matter Expert in assigned QC systems/processes/equipment to oversee the implementation and management of systems/processes.
• Owns QC related polices and procedure of the assigned QC processes which include product testing, materials testing, environmental monitoring, method development/qualification/validation, lab investigations, stability testing, LIMS, lab equipment qualification and/or calibration.
• Ensure timely completion of assigned activities which include testing, method development/qualification/validation, equipment qualification or computer systems validation as per agreed lead-time/milestones.
• Initiates/Reviews/approves procedures, documents, records, deviations, investigations, corrective action/preventive actions, changes controls and gaps assessment associated with the QC area(s) assigned.
• Ensure QC personnel are qualified and trained to perform assigned tasks.
• Support product/materials testing, methods qualification/validation activities, equipment qualification activities or other QC related activities as an executor, reviewer and/or approver.
• Ensure products are tested and assessed per applicable current GxP and regulations.
• Ensures that facilities, equipment, materials, processes and procedures that are applicable to QC comply to applicable, current GxP and regulations.
• Manage performance and development of direct reports to ensure achievement of organizational goals.
• Supports improvement initiatives, programs and projects driven from the Quality Management System.
• Escalates quality and compliance risks to QC and QA Management.

Note: Other responsibilities may be assigned by Head of Quality, or senior management

Requirements

• Bachelor or higher, in Science, Pharmacy, Pharmaceutical Science, or equivalent, with preference of more than 6 years of relevant work experience in Quality Assurance Lead role in the pharmaceutical/biotechnology/medical device/healthcare industry, preferable with increasing people management responsibilities.
• Extensive knowledge in Quality Management System concepts
• Extensive knowledge in regulations and industrial guidance especially for stem cell / cell and gene therapy
• Excellent communication and able to engage stakeholders effectively from different functional units
• Critical thinking and problem-solving skill are of advantage.