Compliance Scientist: Artwork and Research for Safety Information

3 days ago


Southern Suburbs, South Africa Pharma Dynamics (Pty) Ltd. Full time

**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.
- BSc degree


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