Our Pharmaceutical client has an opportunity of a Regulatory Affairs Quality Executive permanent employment. The successful incumbent will be based on the north of Johannesburg.

The Purpose of the position :
To ensure the Regulatory Affairs South and Southern Africa Department processes and systems are implemented and operating in compliance with local legislation and organization's global quality and regulatory standards and requirements including Risk Management; OPAL; GRACE; QMS; REQUIRE etc.

Essential Job Responsibilities:
1.Ensures Department audit readiness
2.Acts as Department Risk Management Champion Ensuring Risk Management implementation and monitors and maintains Department achievement of performance targets and compliance status.
3.Keeping abreast of all developments and changes in the Southern African regulatory environment and establishing and maintaining effective means to updating REQUIRE
4. Ensures Licences are valid and compliant
5. Ensures L1 audits, L2 audits and CAPA’s are performed and closed out on time.

Other Responsibilities :
1. Maintain audit readiness and co-ordinate so that audits are performed on time, audit outcomes are successful and audit reports and CAPA’s are closed out on time.
2. Manages daily workload on a consistent basis.
3. Maintains and monitors training, QMS, Risk Management, OPAL and GRACE implementation to enable Regulatory Affairs Department to achieve performance targets and compliance status.
EXPERIENCE AND QUALIFICATION
5 years working experience in a senior management role Regulatory Affairs
Bachelors degree Pharmacy