Scientific Affairs Scientist (Fixed-Term : Maternity Cover)

Pharma Dynamics (Pty) Ltd.; South Africa; 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, operational activities, and ensure compliance with GMP principles. Responsibilities include maintaining quality records, liaising with suppliers, and supporting regulatory affairs. Experience in the pharmaceutical sector and knowledge of regulatory requirements are essential for this role.

Qualifications

• Experience in Quality Assurance processes within the pharmaceutical industry.
• Knowledge of regulatory requirements and GMP principles.
• Ability to handle documentation accurately.

Responsibilities

• Assist with documentation related to product release.
• Support daily Quality Assurance activities.
• Maintain GMP principles and assist with training.

Skills

Attention to detail

GMP compliance

Database management

Tools

CAMS database

DocuBridge

Artwork application

Job description

QUALITY ASSURANCE

Product Release :

• Assist with documentation related to product release, ensuring accurate records and data capture.
• Assist with 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 :

• Support day-to-day Quality Assurance activities, ensuring adherence to plans and schedules.
• Complete database entries, registers, and forms accurately.
• Assist in the compilation and review of departmental SOPs.
• Record CAPAs, deviations, and other reports.
• Support quality-related investigations.
• Record and arrange destructions as required.
• Liaise with suppliers as needed.
• Perform administrative duties as assigned.
• Support annual reviews per product, including report preparation, sample inspections, and supplier requests.
• Assist with tracking, communication, and support of annual QA plan activities.
• Review laboratory and stability results.

REGULATORY AFFAIRS

• Assist with registration and commercialization of complementary products.
• Align product dossiers across all markets.
• Update SAHPRA CAMS licenses for new products or changes.
• Respond to regulator queries, safety updates, and variations within specified timeframes.
• Maintain online applications (CCP database, DocuBridge, Artwork app) as per SOPs.
• Review product artwork for compliance with registration and labelling regulations.

GENERAL

GMP :

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

Training :

• Attend or present training sessions as required.