Responsible Pharmacist (Half Day) - Regulatory

SUMMARY:
A well-known Pharmaceutical Ingredient Company supplying the pharmaceutical manufacturing industries requires the above to manage and oversee all scheduled and control substances supplied to the pharmaceutical manufacturing industry.

POSITION INFO:

Minimum requirements for the role:

• Tertiary qualification in a BPharm degree or related and registered with the South African Pharmacy Council is essential.
• Previous experience having worked in quality assurance and regulatory affairs within the pharmaceutical industry is essential.
• Experience in quality control or quality assurance would be advantageous.
• 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.

The successful candidate will be responsible for:

• Ensure high standards of pharmaceutical care in accordance with good practice and other legal requirements.
• Ensure compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974.
• Ensure compliance to all applicable legislative requirements for the Company’s product portfolio and all regulations and guidelines pertaining to the import and export license for medicinal products and good manufacturing practices.
• Ensure compliance with statutory/regulatory requirements of the various authorities in South Africa and related authorities in other African countries where products are sold.
• Provide regulatory intelligence and advice to the Business Divisions with regards to regulatory changes affecting the importation and exportation of the products.
• Respond to requests adequately, satisfactorily and timeously for external Customers.
• Compile dossiers and technical files for registration applications of new products in South Africa and related authorities in other African countries.
• Maintain existing dossiers and technical files, as per global and local health authority requirements.
• Submit and follow-up on all product registration amendments.
• Manage the quality control system.
• Liaise with source of supply on all quality related issues.
• Compile release documentation and release of all products.
• Investigate and report on customer complaints as per local and Company requirements.
• Investigate and report on defective and rejected products.
• Perform all daily activities in line with the Company’s policies and code of conduct, integrity and compliance.

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

NB! This job is now closed. You can apply for other jobs by uploading your CV.