* BSc Chemistry with statistical analysis skills. 1 years’ relevant working experience in a chemical or pharmaceutical manufacturing environment.*

Location: Epping, Cape Town

Description: A pharmaceutical manufacturer requires a Regulatory Affairs Compliance Officer to join their regulatory affairs department. Key duties will include: compiling and updating API quality system documentation and documentation for regulatory submissions; drawing up evaluation reports by gathering, processing (graphically and statistically) and evaluating data, delivering conclusions and discussing findings; evaluation of internal work processes and API production process improvement opportunities; planning and documentation of process improvement ideas and execution of projects; understanding legislation and policies regarding process validation and annual product reviews; knowledge of statistical tools, quality management system processes including change control, deviation control, specifications and stability; compliance with GMP requirements.

Key Requirements: BSc Chemistry with statistical analysis skills. 1 years’ relevant working experience in a chemical or pharmaceutical manufacturing environment.

Additional Requirements: Good interpersonal skills. Good organizational and system implementation skills. Exceptional attention to detail and accuracy. Able to critically evaluate data. Good written and verbal communication skills. Excellent report writing and document reviewing skills. Ability to perform tasks concurrently. Self-motivated.

Remuneration: Market related and dependent on experience.

Starting date: As soon as possible

*Only candidates that meet all the requirements should apply
**Please quote “Regulatory Affairs Compliance Officer (W449) in the subject line
***Only candidates that are shortlisted will be contacted