Quality Assurance Document Manager
2 weeks ago
**JOB PURPOSE**
Implementation and maintenance of quality at Synexa Life Sciences.
**MAIN AREAS OF RESPONSIBILITY**
- Support with quality responsibilities relating to management of SOP system, CAPA, eQMS, Master Schedule, Change Control and Risk management.
- Support with the maintenance of quality at Synexa Life Sciences in compliance with GLP, GCP, GMP and GCLP.
- Continuous improvement of quality system.
- Responsible of administration of electronic archiving and maintenance of the e-archive system.
- Other responsibilities as documented in the List of responsibilities.
**QUALIFICATION AND EXPERIENCE**
- More than 2 years' experience in an accredited laboratory
- Applicable natural science qualification
- Good knowledge of the principles of GCLP (GCP, GLP and GMP will be an advantage)
- Good knowledge of written and spoken English
- Willingness to continuous training and act as trainer for Synexa Life Sciences personnel
- Willingness to travel when necessary.
- Working knowledge of LIMS and eQMS systems.
**TASKS, SKILLS AND COMPETENCIES REQUIRED**
- Write standard operating procedures (SOPs of SOP management, CAPA, eQMS, Master Schedule, Risk management, Change Control management).
- Management of (GLP/GCP/GCLP) SOP system.
- Administration of e-archiving system and document management of archived electronic data.
- Administration and maintenance of eQMS.
- Administration and maintenance of Master Schedule.
- Maintenance the CAPA.
- Risk management.
- Change Control management.
- Good presentation skills
- Excellent attention to detail
**LOCATION
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