Scientific Affairs Scientist (Fixed-Term: Maternity Cover) at Pharma Dynamics (Pty) Ltd

Description

QUALITY ASSURANCE

Product Release:

• Assist with any/all documentation relating to product release and the accurate capturing of records and data.
• Assist with the control and storage of release samples.
• Perform Lot release checks according to prescribed procedures to ensure GMP compliance.
• Assist with Data Logger handling and temperature monitoring activities. 

Operational Activities:

• Assist with delivery of day-to-day Quality Assurance activities, ensuring adherence to plans and schedules.
• Assist with the accurate completion of all database 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 quality related investigations.
• Assist with recording and arranging destructions as and when required.
• Liaise with suppliers as and when required.
• To carry out any other administrative duty as and when required
• Assist with annual reviews per product including but not limited to report preparation, sample inspections and supplier requests.
• Assist with tracking, communication, and support of annual QA plan activities.
• Assist with review of laboratory and/or stability results. 

REGULATORY AFFAIRS

• Assist with the registration process and commercialisation of Complementary products in consumer portfolio
• Align all Complementary product dossiers across all markets
• Update the SAHPRA CAMS licence (3D-licence) when required – New CAMS products or changes to existing products
• Compile and submit all responses to Regulator queries, safety updates and variations, within agreed and specified time limits.
• Maintain the department’s online apps (CCP database, docuBridge, Artwork app) as per official SOPs and/or working instructions.
• Review product artwork and ensures compliance with registration and labelling regulations of Medicines and Related Substances Act 101 of 1965.

GENERAL

Good Manufacturing practice (GMP):

• Maintain all GMP principles in line with departmental Quality System and SAHPRA requirements.

 Training:

• Attend and/or present training sessions as and when required

Requirements

PRE-REQUISITES

• Bachelor's degree in relevant scientific discipline.
• Proven experience in quality assurance and/or regulatory affairs within the pharmaceutical industry (advantageous).
• Strong knowledge of GMP and GDoc practices, including SAHPRA and international guidelines.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments.
• Detail-oriented with strong analytical and problem-solving abilities.
• Demonstrated ability to drive continuous improvement and implement best practices in quality assurance