Job Description

Key Responsibilities

Operational activities:

• Assist in maintaining the administrative functions relating to sample ordering, sample receiving, communication and shipment
• Maintenance of the sample cupboard inventory
• Printing, burning of CD/DVD-ROMs and packaging of dossier submissions to Export countries
• Assist with OTC dispensing in line with business requirements
• Ensure the electronic database is updated with all new correspondence, registration certificates, dossiers and supplier information for Export portfolio
• Requests translations of documents for Export RA department
• To assist with the compilation and submission of administrative documents to neighbouring countries
• Collates and submits certificates of analysis for export orders and tender documents
• Collates requested certificates for Supply Chain stock shipment and price reduction for Marketing
• To assist with the maintenance of application history by product for Export portfolio
• To assist Regulatory Affairs with the management and reporting of Change Control Procedures (CCPs)
• Submit Site Master Files (SMF) to SAHPRA
• Compile and coordination of CPP applications for the Export market
• To provide the necessary RA information to Compliance and Quality Assurance as and when required
• Liaise with Managers, Scientists, Pharmacists and other departments to ensure deadlines are met and all administrative RA tasks are completed in time

Operational efficiency * Contribute to the creation and implementation of best practice processes and procedures to aid and improve operational performance

• Contribute to timeous implementation of Export RA projects

Budget and Reporting * To assist with all payment requests and ensure approvals are obtained and processed in line with company procedures

• Circulate proof of payments to RA department
• PR creation and SES (SAP) for RA department
• To assist with compilation of monthly RA reports to HOD
• To assist with compilation of minutes and actions as and when required
• To carry out any other administrative duties as and when required

Good Manufacturing practice (GMP) * Maintain all GMP principles in line with departmental Quality System and SAHPRA requirements

Documentation & Systems Management

Documentation

• Assists with SOP tracking and compilation
• Assists with monthly status reports
• Assist with the compilation of applications for Certificates of Pharmaceutical Products and other administrative documents as requested

Systems * Drive accuracy and efficiency of the departmental electronic Document Management System

• al electronic Document Management System

PRE-REQUISITES

• High school certificate (Matric)
• Current or previous experience within an administrative role (minimum 2-3 years)
• Excellent working knowledge of MS Office applications (e.g. Word, Excel, PowerPoint, Teams), and Adobe Acrobat
• Excellent time management skills and the ability to prioritize work
• Attention to detail and problem solving skills
• Excellent written and verbal communication skills
• Strong organizational skills with the ability to multi-task
• Familiarity with the administrative functions within a regulatory affairs environment is advantageous

Pharma Dynamics