Job Description

Minimum requirements for the role:

• A B Pharm degree registered with South African Pharmacy Council.
• Previous experience having worked in a responsible QA/QC pharmacist role handling regulatory aspects of the role as well within a pharmaceutical or related manufacturing industry is essential for the role.
• The successful candidate must have the ability to manage priorities, and work on multiple matters at once.
• Must have the ability to meet deadlines.
• Must have good communication skills.
• Must have good Excel skills.

The successful candidate will be responsible for:

• Ensuring high standards of pharmaceutical care in accordance with good practice and other legal requirements.
• Ensuring compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974 as well as all applicable legislative requirements for the companys product portfolio and all regulations and guidelines pertaining to the import/ export license for medicinal products and good manufacturing practices.
• Ensuring compliance with statutory/regulatory requirements of the various authorities in South Africa and related authorities in other African countries where products are sold.
• Prove regulatory intelligence and advice to the business divisions with regard to regulatory changes affecting the importation and exportation of the products.
• Responding to requests adequately, satisfactorily and timeously for external customers.
• Managing compilation of dossiers/technical files for registration applications of new products in South Africa and related authorities in other African countries.
• Maintaining existing dossiers/technical files, as per global and local health authority requirements. Submission and follow-up of all product registration amendments.
• Managing the quality control and assurance of all products.
• Liaising with the source of supply on all quality-related issues.
• Compiling all release documentation as well as the release of all products.
• Investigating and reporting on customer complaints as per local and company requirements.
• Investigating and reporting on defective/rejected products.

Salary package, including benefits, is highly negotiable depending on experience gained.

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