POSITION SUMMARY

The QA&RA Lead will ensure compliance with regional and global regulatory requirements in the African market, manage the release of veterinary and related products to various markets, and assure adherence to Good Distribution and Laboratory Practices. This role includes overseeing repackaging operations, deploying the Quality Management System, and acting as the Pharmaceutical Complaint Officer. Additionally, the RA&QA Lead will lead the Regulatory Affairs (RA) and Quality Assurance (QA) team across Africa to provide support and ensure that all processes and activities comply with regulations and business objectives. As a member of the Africa Leadership Team, the candidate will be accountable for achieving company objectives.

EDUCATION AND EXPERIENCE

• Degree in Pharmaceutical sciences
• Registered with the South African Pharmacy Council (SAPC)
• At least 5 years’ Quality management experience within an operational pharmaceutical environment, including previous experience as a Responsible Pharmacist.
• Extensive experience in regulatory affairs and quality assurance.
• At least 5 years’ people management experience.
• Knowledge of current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Pharmaceutical legislation and regulations (e.g. CFR, ICH, Ph.Eur, USP).
• Experience in working with other African Markets would be an advantage.
• A good understanding of regulations and guidelines applicable to stock remedies and feed additives would be an advantage.

TECHNICAL AND BEHAVIOURAL SKILLS REQUIREMENTS

• Excellent leadership, collaboration and interpersonal skills.
• High level of ethical integrity and accountability.
• Excellent communication and organizational skills.
• Good negotiation and influencing skills.
• Excellent written and verbal communication in English.
• Ability to develop strategic direction for the business.
• Ability to identify and act on business opportunities.
• Strong problem solving and analytical skills.
• Capacity to adapt to changing regulatory environments.

PHYSICAL POSITION REQUIREMENTS

• Ability to drive and travel locally and internationally if required.
• May be requested to work extended hours and weekends for special program events and/or training

• Responsible Pharmacist for Zoetis South Africa, as required by South African pharmaceutical legislation. (for example:- The Medicines and Related Substances Act 101 of 1965 (as amended) and the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1847 (as amended).
• Manage release of all veterinary and other related products (locally manufactured or imported) to the South African market and other markets falling under the responsibility of the South African Market (e.g. Namibia, Botswana, Swaziland and Lesotho).
• Manage release of any veterinary and other related product (locally manufactured or imported) to other African markets falling under the responsibility of the Sub-Saharan African General Manager.
• Assure Good Distribution Practices for the African Market in accordance with corporate standards and local regulations.
• Assure Good Laboratory Practices of local contracted Laboratory services to test imported products.
• Assure repackaging operations in accordance to GMP requirements, corporate standards and local regulations.
• Implement and oversee the Quality Management System (QMS and quality assurance plans for Zoetis Africa.
• As a member of the Zoetis Africa Leadership Team, be mutually accountable for the achievement of the Company objectives.
• Act as Local Pharmaceutical Complaint Officer (LPCO).
• Lead the Zoetis Africa Regulatory Affairs team to ensure that: a) Products are registered in accordance with the business objectives and applicable legislation and guidelines. b) Product registrations are aligned with current manufacturing practices.
• Product packaging (Artwork) is compliant with the product registration.
• Support the African Region’s Business Operations in their mission to provide customers with quality and compliant products, in due time at the expected cost.
• Maintain and review relevant documentation, including quality records, audit reports, and regulatory submissions.
• Develop and deliver training programs for staff on quality assurance procedures and regulatory requirements.
• Manage the release of veterinary products imported into South Africa from third countries according to the relevant legislation and guidance (note, Quality oversight and release of local contract manufactured products to be delegated to External Supply Quality Assurance Manager), including any local locally relabeled and repackaged products:
• Be the Responsible Pharmacist for distribution in compliance with South African regulation (i.e. Acts 101 & 36). Within the scope of distribution are: the local distribution to the South African market, the transportation, import, export and storage activities managed by or in behalf of the Company, including quality oversight of contracted logistics companies.
• Be the primary contact and oversee quality- compliance of feed-additives according to relevant regulations.