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    Quality Assurance Executive - Singapore - SCG CELL THERAPY PTE. LTD.

    SCG CELL THERAPY PTE. LTD.
    SCG CELL THERAPY PTE. LTD. Singapore

    6 days ago

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    Description
    Roles & Responsibilities

    About SCG

    SCG Cell Therapy Pte Ltd is a clinical-stage biotechnology company focusing on the development of novel immunotherapies for patients with pathogenic infections and it associated cancers. Our strategy is to harness patient's immune system by redirecting cellular responses toward pathogens and its associated cancer using adoptive cell therapy, bispecific antibodies and vaccines.

    Position Summary

    The candidate will serve as the main document controller and training administrator under the QA team, under the supervision of the QA manager. He/she will also be expected to contribute to the maintenance and continuous improvement of the site's record and document management system.

    Core responsibilities

    • Oversee the creation, revision, and distribution of documents in adherence to established site procedures and guidelines
    • Manage the creation, revision, and distribution of documents in accordance with established procedures
    • Provide training to employees on document control processes, standards, and systems
    • Review documentation and records for ALCOA+ and compliance with regulatory requirements
    • Conduct routine onsite inspections of record keeping and form completion during production and QC procedures
    • Manage, coordinate and evaluate employee training programs
    • Collaborate with subject matter experts to design and update training materials
    • Support audits by regulatory authorities and notified bodies when required
    • Identify areas within the document control and training programs for improvement

    Role requirements

    • Diploma/Degree, preferably in the chemical or life sciences
    • At least 1 year of experience in a document controller role, or 3 years in a GMP environment
    • Familiarity with the design, implementation, and evaluation of training programs
    • Experience with regulatory audits is a plus
    Tell employers what skills you have

    Document Management
    Food Safety
    Quality Management
    Quality Assurance
    ISO
    GMP
    Biotechnology
    Compliance
    Employee Training
    Audits
    Regulatory Requirements
    Life Sciences
    Antibodies
    Cell Therapy


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