RA Compliance and Artwork Manager - Randburg
MNA Recruitment
Reference: DBN003396-SS-4A leading pharmaceutical company has a vacancy for an RA Compliance and Artwork Manager. Job Purpose: To consider, examine, correct and approve all printed packaging and promotional material and advertisements, meetings, events and other interactions with healthcare professionals and ensure that they are legally compliant with the statutory laws, regulations, rules and standards (as per the King Code of Governance South Africa). Provides support for control improvements and remediation activities including standardisation, new processes and systems and new organisational constructs. Drafts reports and recommendations for internal control deficiencies resolution or improvements to facilitate sharing of best practices related to key controls for assigned processes. Provides policy and procedure guidance Key Responsibilities: Ensure that all promotional material and packaging is legally compliant with the relevant statutory laws, regulations, rules and standards. Approving all artwork pieces in compliance with specified guidelines (requires a sound knowledge in both the English & Afrikaans languages). SAHPRA Regulations Act 101 of 1965; Foodstuff, Cosmetics and Disinfectants Act 54 of 1972, and Trade and Metrology Act. Ensure corrective action for meetings, events and other activities in line with the applicable regulatory framework. Ensure that all samples requested are appropriately approved and documented according to the regulatory framework. To timeously and efficiently handle and resolve all complaints related to the abovementioned functions. Review and approve SOPs for the Compliance department, as well as establish the need for additional controls or processes for effective quality control. Provide training of all relevant staff on the Marketing Code of practice, as well as ensuring MCA certification is obtained. Compiling statistics and reports on a monthly basis to the Head of Quality, Compliance and RA Ensure that Risk Assessments are performed Ensure that Self Inspections are performed and that CAPAs are identified Updating and maintenance of databases to ensure that the current approved information is reflected Any future changes to the regulations and guidelines to be implemented at operational level. Requirements: Bachelor of Pharmacy with registration with the South African Pharmacy Council Prior experience in the pharmaceutical industry in the Regulatory or related environment At least two years working experience in the field of artwork and promotional material Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.comShould you receive no feedback within 7 days, please accept your application as unsuccessful.
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