Quality Control Engineer

7 days ago


Singapore SCG CELL THERAPY PTE. LTD. Full time

**Quality Control Engineer
SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, human papillomavirus, and hepatitis B, and develops a broad and unique pipeline of T cell therapies, antibodies, and therapeutic vaccines against infections and to prevent and cure its associated cancers. Established and headquartered in Singapore, SCG combines regional advantages in Singapore, China and Germany, covering the entire value chain from innovative drug research and discovery, manufacturing, clinical development and commercialization. SCG collaborates with leading scientists and researchers to bring first-in-class and best-in-class medical products/technologies to enhance innovation in medical product development.

Key responsibilities

The QC Engineer will be responsible for daily quality control activities and ensure all activities are according to SOP and GMP requirements including liaising with external manufacturing and testing labs.
- Perform testing of the in-process, final product, and stability samples according to SOP and GMP requirements.
- Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment
- Prepare and review external and internal protocols and other documentation as required to support external testing lab and manufacturing services. (Ensure BMR records are up-to-date, complete and accurate; Monitor microbial testing program; Verify test results).
- Support regulatory submissions.
- Develop, write and execute methods, protocols, reports and other related documents.
- Perform and complete Change Control, Investigations, and Corrective/Preventive Actions associated with QC and/or process deviations.
- In collaboration with the Quality Assurance department, provide technical assistance in the development, and maintenance of raw materials and finished product specifications.
- Prepare and present continuous improvement projects to the management
- Performs special assignments in assay tech transfer, validation, or other technical projects as assigned by the management.

**Requirements**:

- Minimum Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or related life Sciences or Technology with about 2-5 years of experience in QC lab in the pharmaceutical or biotechnology industry.
- Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories.
- Excellent verbal, written, and interpersonal communication and presentation skills.
- Knowledgeable of FDA regulations and ICH Guidelines regarding the manufacture of biological including regulatory inspection experience.
- Effective problem-solving skills and good understanding of risk-based decision framework
- Experience with method validation and technology transfers
- Experience with equipment qualifications and analytical instrument/software validations
- Experience with flow cytometry, qPCR, cell culture, immunology and assay development/validation
- Experience with Cell/Gene Therapy preferred.



  • Singapore VSL SINGAPORE PTE. LTD. Full time

    Position Summary: The Quality Control Engineer is an experienced engineer with a good understanding of construction principles, standards and processes. The QC Engineer is responsible to identify the measures and controls required to give a reasonably practical assurance that the quality of the works will be achieved. The QC Engineer will have a detailed...


  • Singapore AUTHENTIC HR PTE. LTD. Full time

    Roles & ResponsibilitiesWork Schedule: 5-day week, 8:00 am – 5:30 pmSalary: S$3,000 – S$4,000 (commensurate with experience)Job SummaryWe represent our client, an established aerospace engineering company, to seek a Quality Engineer to drive product excellence and ensure compliance with customer and regulatory requirements. The role oversees inspection...


  • Singapore AUTHENTIC HR PTE. LTD. Full time

    Roles & Responsibilities Work Schedule: 5-day week, 8:00 am – 5:30 pm Salary: S$3,000 – S$4,000 (commensurate with experience) Job Summary We represent our client, an established aerospace engineering company, to seek a Quality Engineer to drive product excellence and ensure compliance with customer and regulatory requirements. The role oversees...


  • Singapore AUTHENTIC HR PTE. LTD. Full time

    **Work Schedule**:5-day week, 8:00 am - 5:30 pm **Salary**:S$3,000 - S$4,000 (commensurate with experience) **Job Summary** We represent our client, an established aerospace engineering company, to seek a **Quality Engineer**to drive product excellence and ensure compliance with customer and regulatory requirements. The role oversees inspection activities,...


  • Singapore ScopeHR Services Full time

    Quality Control Engineer - Manufacturing As a Manual, Policies, and Procedures Specialist, you will be responsible for developing and implementing manuals, policies, processes, and procedures to ensure compliance with ISO-14001 standards. Your role will involve controlling internal PPM, supplier PPM, and managing internal and external complaints...


  • Singapore ScopeHR Services Full time

    Quality Control Engineer - Manufacturing As a Manual, Policies, and Procedures Specialist, you will be responsible for developing and implementing manuals, policies, processes, and procedures to ensure compliance with ISO-14001 standards. Your role will involve controlling internal PPM, supplier PPM, and managing internal and external complaints...


  • Singapore SREE RAM CONSTRUCTION PTE. LTD. Full time

    The QAQC Engineer is responsible for ensuring the quality and integrity of project works throughout all phases of design, fabrication, installation, and commissioning. This role involves implementing quality control procedures, conducting inspections, performing tests, and collaborating closely with project teams to achieve high-quality project installations...


  • Singapore GRAND TEAM TECHNOLOGIES PTE. LTD. Full time

    **Duties & Responsibilities** 1. To execute the policy of ISO 9001:2015 quality management system 2. Carry out effective internal quality audit and reliable inspection of incoming supplies work-in-progress, and finished parts/ components 3. Keep track and validate of special quality requirements of customers, geometrical symbol, tolerances and...


  • Singapore Jetstar Full time

    Jetstar thrives on innovation. We're always looking for dynamic and proactive professionals to help our business work smarter and more efficiently. You will be encouraged to think innovatively whilst developing and maintaining best practice. What’s more, this role will see you working as part of a broader group Jetstar and Qantas structure. Our team is...


  • Singapore PREMPLAS TECHNOLOGIES PTE. LTD. Full time

    Roles & ResponsibilitiesPrepare quality reports, perform process audit, develop & implements quality assurance standards, policies, processess & controls. Able to liaise & resolve with customers on quality related issues. Data compliation, co-ordination and facilitation of all internal and external audits, re-certification of ISO 9001.Tell employers what...