Summary
Reporting to the Head of Quality Management, the position will be responsible for acting as a link between BVI and regulatory authorities locally, regionally and internationally. Additionally, ensuring that vaccines are manufactured and distributed in compliance with appropriate legal and regulatory requirements, as well as, Good Manufacturing Practice and other Quality Assurance Standards in the different countries.
Description
The incumbent will be responsible for, among others, the following;
- Developing a register of all institutions, agencies that regulate the manufacturing and supplying of pharmaceutical and veterinary products in the current and prospective markets where BVI sells its products.
- Studying scientific and legal documents to familiarize self with the requirements and create awareness in the company of all requirements for compliance.
- Conducting regular surveillance with the production and quality teams, whilst, ensuring that they comply with the conditions designated in relevant regulations for obtaining and maintaining the license including the BVI QMS and GMP requirements.
- Reviewing quality management audit reports to identify non-conformance with regulations and engage the teams on corrective action to maintain product licensure.
Minimum Requirements
The right candidate will possess the following minimum requirements:
A minimum of a Bachelor’s Degree in Medicine, Veterinary, Pharmaceutical or Scientific Degree or its equivalent.
Professional/Technical working knowledge of quality management systems (ISO), Good manufacturing practice, application for licensure and registration of pharmaceutical products.
A minimum of three 3 years’ appropriate experience in health products production or regulation or experience in corporate health products and services regulatory environment.