Medical Laboratory Technologist / Sr Medical Laboratory Scientist (QC), NCIS(8282)

NATIONAL UNIVERSITY HOSPITAL (SINGAPORE) PTE LTD; Singapore; On-site; SGD 45,000 - 75,000; Full time

Job summary

Ein innovatives Unternehmen im Gesundheitswesen sucht einen Quality Control Specialist, um die Qualität von Produkten und Prozessen sicherzustellen. In dieser Schlüsselrolle übernehmen Sie die Verantwortung für die Durchführung von Qualitätskontrollen, die Koordination von Testaktivitäten und die Sicherstellung der Einhaltung von cGMP-Vorgaben. Sie werden auch an der Erstellung und Überprüfung von SOPs beteiligt sein und als Fachexperte während interner und externer Audits fungieren. Wenn Sie eine Leidenschaft für Qualität und Compliance haben und in einem dynamischen Umfeld arbeiten möchten, ist diese Position ideal für Sie.

Qualifications

• Mindestens 2-4 Jahre Erfahrung in der Qualitätskontrolle in der Pharma- oder Biotechnologie.
• Gute Kenntnisse der regulatorischen Anforderungen für Zell- und Gentherapie.

Responsibilities

• Durchführung von routinemäßigen Qualitätskontrolltests und Koordination von Testaktivitäten.
• Erstellung und Überprüfung von SOPs sowie Unterstützung bei Audits.

Skills

Qualitätskontrolle

Analytische Fähigkeiten

Mikrobiologische Tests

Problemlösungsfähigkeiten

Kommunikation

Education

Bachelor in Wissenschaften oder Pharmazie

Tools

cGMP-Verfahren

Qualitätsmanagementsysteme

Job description

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) Specialist for the QC department in the organisation.

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 Specialised 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.