Scientific Affairs Scientist

Pharma Dynamics (Pty) Ltd; Wes-Kaap; On-site; ZAR 200,000 - 300,000; Full time

Job summary

A leading pharmaceutical company in South Africa is seeking a Quality Assurance professional to assist with product release documentation, maintain GMP compliance, and support day-to-day QA activities. The ideal candidate will help with regulatory affairs and undertake quality-related investigations. Strong attention to detail and knowledge of compliance standards are essential for this role.

Qualifications

• Assist with documentation relating to product release and record keeping.
• Perform Lot release checks to ensure GMP compliance.
• Assist with quality-related investigations and reporting.

Responsibilities

• Support day-to-day Quality Assurance activities.
• Assist with annual reviews and tracking of QA plan activities.
• Assist with registration processes for complementary products.

Job 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