Wy - Quality Assuarance Executive

2 weeks ago


Singapore STAFFKING PTE. LTD. Full time

**Summary**
- Salary up to $5500
- Tai Seng
- 5 Days, 9am - 6pm
- Biotechnological Manufacturing industry

**Responsibilities**:

- Assist in creating and managing Quality Assurance documents.
- Inform Facilities/Engineering/Supply Chain and Quality Control teams about cGMP and hygiene procedures for dispensing and production areas.
- Write, review, and approve controlled QA documents like SOPs, batch records, and work instructions.
- Issue SOPs for site qualification and validation projects (e.g., technology transfer).
- Prepare final batch release documentation, review/approve batch records, and ensure timely closure of batches.
- Review and approve maintenance/calibration records for facilities/utilities/equipment and computerized systems to ensure cGMP compliance.
- Review and approve environmental monitoring data, analyzing trends for potential impact.
- Review and approve validation deliverables for facilities/utilities/equipment, computerized systems, and laboratory equipment/systems to meet regulatory and project requirements.
- Participate in Risk Assessment and provide QA input to ensure cGMP compliance.
- Contribute to User Requirements Specification and Facilities/Engineering Qualifications, Processes Validation, and Computerized System Validations to comply with cGMP requirements.
- Support deviation root-cause investigations and review/approve related documentation.

**Requirements**:

- Qualifications in Biomedical, Biotechnology or other relevant fields
- Understanding of GLP-Lab/GMP Operations, QC, QA, Process Development, Supply Chain, and related functions such as Facilities/Engineering
- 3-5 years experience in Bio-Life science environment.

To Apply, kindly click on the "APPLY NOW" button

Staffking Pte Ltd (20C0358) | Khor Wan Ying (R22109948)


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