Key Job Output:

• Evaluate and provide advice with respect to current formulations and processes.
• Provide improvements for product processes to increase manufacturing efficiencies.
• Compile protocols and reports for relevant activities.
• Observe product manufacturing processes in the facility and record data as per approved protocols.
• Collate, analyse and discuss data in respective reports, and make recommendations.
• Conduct risk assessments on products and processes.
• Control and submission of samples for analysis and providing required documentation.
• Assist with investigations and report writing.
• Collate data from multiple sources for investigations.
• Complete investigations with workable solutions.
• Identify, where possible, root causes of issues and plan a course of action for further investigation and/or corrective actions.
• Complete investigations within allocated timelines.
• Evaluate new product manufacturing documentation.
• Ensure new products are optimised and introduced successfully into the manufacturing facility.
• Conduct trials as per SOP where necessary using relevant documentation.
• Compile, update and review SOP’s timeously according to current procedures.
• Raise relevant deviations, change controls, CAPAs and incident forms where necessary.
• Assist with preventative/corrective actions with regards to audit responses.
• Ensure all work performed is of the highest quality and in full compliance with GxP’s, SOP’s, regulations and safety standards.
• Administrative duties (filing and maintaining relevant data bases).

Requirements

• Matric Certificate.
• Appropriate tertiary qualification and relevant experience.
• Pharmacist Assistant Basic / Post-Basic advantageous but not necessary.
• Excellent computer literacy especially in MS Office mandatory.
• 3 – 5 years’ experience in a pharmaceutical manufacturing environment. (specifically in production) or Direct experience is process validation.
• Understanding of GLP, GMP, Regulatory guidelines (SAHPRA, ICH, etc.).