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RA Compliance Pharmacist: Artwork and Launch

Company Pharma Dynamics
Reference # RAP_2021
Published 09/09/2021
Contract Type Permanent
Salary Market Related
Location Tokai, Western Cape, South Africa
Introduction
We seek to appoint an experienced RA Compliance Pharmacist to manage all aspects of the compilation, coordination and implementation of new and existing artwork in line with new launches, order status and business needs
Job Functions Compliance & Regulatory Affairs
Industries Pharmaceutical / Medical / Healthcare / Hygiene
Specification
KEY RESPONSIBILITIES

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
•Allocate PPM codes, barcodes and raise CCP’s 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 including printers and packers to ensure artwork projects are delivered on time
•Proactively plan implementation and availability of printer proofs at supplier/printers
•Liaise with managers and Heads of department to ensure launch plans are met
•Assist with the implementation and coordination of departmental operational activities to ensure timeous launch of new and existing brands
•Assist with the approval of advertising and promotional material
•Monitor non-conformances and provide a progress report monthly to Head of Department on artwork/project status
•Review artwork components in line with legal requirements and business needs as per agreed timelines
•Assist with preparation of internal self-inspections
•Coordinate and manage the alignment of artwork and safety updates for the export market
•Drive the implementation of safety information for the South African market

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 the compilation and tracking of product status registers
•Manages the implementation of artwork and promotional material in line with business requirements
•Manages adherence to SOP’s and departmental deadlines
•Compiles monthly status reports

Systems
•Drive accuracy and efficiency of the departmental eDMS
•Ensure ongoing compliance with SAHPRA requirements
Requirements
PRE-REQUISITES
•B-Pharm registration with SAPC
•Minimum 3- 5 years working experience in a generics pharmaceutical environment
•Project management experience essential
•Critical knowledge of Act 101 and Marketing code
Job Closing Date 21/09/2021
   
   
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Last Updated: 30-6-2021 [21.06.02.21]
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