Quality Assurance Executive

2 days ago

Singapore SCG CELL THERAPY PTE. LTD. Full time

**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
**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
- 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

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