Compliance Scientist: Artwork and Research for Safety Information at Pharma Dynamics (Pty) Ltd

Description

Strategy and Development

• Contribute to the creation and implementation of best practices processes and procedures to aid and improve operational performance and timeous availability of product to market.
• Contribute to new business initiatives and projects.

Operational activities:

• Coordinate the compilation of artwork packs in line with internal procedures and legal requirements
• Implement PPM codes, barcodes and CCP’s (initiated by Regulatory Department), where necessary in line with departmental policies and procedures
• Liaise with Supply, Regulatory Affairs, Marketing and Design department to ensure operational and legal requirements are met
• Liaise with external stakeholders and suppliers, including printers and packers, to ensure artwork projects are delivered on time
• Proactively plan implementation and availability of printer proofs at supplier/printers
• Assist with the implementation and coordination of departmental operational activities to ensure timeous launch of new and existing brands
• Monitor non-conformances and provide a progress report timeously to Associate Director: Compliance & Pharmacovigilance
• Review artwork components in line with legal requirements and business needs as per agreed timelines
• Coordinate and manage the alignment of artwork and safety updates for the export market.
• Conduct thorough research into all the relevant ingredients of mostly all complementary products and add the information in the relevant folder
• Drive the implementation for safety information for the South African and Export markets of the complementary products
• Assist in managing technical complaints and answer patient queries
• Assist with the approval of advertising and promotional material of complementary products
• Assist in managing and maintaining safety of all products in line with SAHPRA guidelines.

Good Manufacturing practice (GMP)

• Maintain all GMP principles in line with departmental quality system and SAHPRA requirements.
• Maintain Marketing Code principles.

Documentation & Systems Management

• Documentation
• Manages adherence to SOP’s and departmental deadlines. Systems
• Ensure ongoing compliance with SAHPRA requirements.

Requirements

• BSc degree