Quality Assurance Manager - Cape Town, South Africa - Synexa Life Sciences
Description
Job Purpose:
Implementation and maintenance of quality assurance at Synexa Life Sciences. Ensuring that procedures are in compliance with GCP, GLP and GCLP.
Main areas of responsibility:
Responsible for implementing the quality assurance program at Synexa Life Sciences in Cape Town in compliance with GLP, GCP and GCLP.
Qualification/Experience:
- More than 5 years' experience of GCP and GLP QA work or equivalent
- Applicable natural science
- Good knowledge of the principles of GLP, GCP and GCLP
- Good knowledge of written and spoken English
- Willingness to continuous training and act as trainer for Synexa Life Sciences personnel
- Ability to cooperate and negotiate.
- Persistent and independent way of working
- Knowledge of laboratory SOPs, analytical methods and laboratory functions in general
- Willingness to travel when necessary.
- Working knowledge of LIMS and eQMS systems.
Skills and Competencies:
- To assure that studies are performed in compliance with GCP, GLP and GCLP, and facilities and processes fulfill GCP, GLP and GCLP requirements.
- To follow and implement the South African law, EudraLex, OECD, EMA and FDA guidelines to SOPs.
- To improve of quality system continuously.
- To maintain the audit master list.
- To maintain the CAPA system.
- To maintain the Risk register.
- To write QA SOPs and review other SOPs.
- To participate in computerized system validation team.
- To give GCP, GLP, GCLP and SOP training to personnel.
- To conduct supplier audits. Coordination of authority and sponsor inspections
- To coordinate inspections by the authority and audits of the sponsors.
- Provides guidance and consultation in qualityrelated issues.
_ PLEASE ENSURE THAT YOUR CV/RESUME IS SUMBITTED IN ENGLISH._
- Synexa Life Sciences is committed to achieving transformation and will take it's EE plan and targets into consideration during the selection process._
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