Quality Assurance Manager (x1) - Cape Town at Synexa Life Sciences

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. Continuous improvement of quality system. Auditing according to QA SOPs. Global QA harmonization.  

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 quality-related issues.