Scientific Affairs Scientist

**Operational**
- Assist with delivery of day-to day Quality Assurance activities, ensuring adherence to plans and schedules
- Assist with the accurate completion of all databased entries, registers and forms
- Assist with the compilations and/or reviews of departmental SOP’s
- Assist with recording of CAPA’s, deviations and any other reports
- Assist with investigations on out of specification queries
- Contribute to the discussion relating to risk management and reporting
- Assist with creation of CCP’s as and when required
- Assist with the queries and correspondence relating to product launch meetings and new product launches
- Liaise with supply and marketing on any product related queries
- Assist with recording and arranging destructions as and when required
- Assist with the checking and completion of any charts, registers and forms as and when requested
- Assist with review of laboratory and/or stability results
- Assist with PQRs as and when required
- Assist with the preparation for new launches for existing and new product

**Product release**
- Assist with any/all documentation relating to product release and the accurate completion of related forms and registers
- Assist with the control and storage of release samples
- Assist with the checking of printed packaging components
- Assist, in liaison Export, the control of rework batches for export markets

**Compliance**
- Assist with delivery of day-to day Vigilance activities, ensuring adherence to SAHPRA requirements
- Assist with the accurate completion of all registers
- Assist with the monitoring and checking of master product list
- Assist with technical and customer queries and distribution of samples as per company procedure
- Assist with the compilation and checking of departmental SOP’s
- Assist with compilation of monthly reports
- Assist with relevant requests for legal payments as and when required
- Assist with the compilation of artwork packs as and when required
- Assist with the checking of artwork as and when requested
- Assist with the preparation for launch of new products
- Liaise with supply and marketing on any product related queries
- Assist with the preparation of audit readiness
- Assist with obtaining risk reports in liaison with Lupin and Export division
- Assist with identifying any potential gaps and/or non-adherence to SAHPRA requirements and Quality Management System
- Assist with tracking of any outstanding actions relating to risk reports and/or identified gaps

**Training**
- Attend and/or present training sessions as and when required
- B Sc. Honors degree in the fields of pharmacology, biochemistry, biotechnology, scientific research
- Minimum of 1-2 years experience in a pharmaceutical Scientific Affairs environment