QUALITY ASSURANCE MANAGER – Portfolio Pharmaceuticals

QUALITY ASSURANCE MANAGER

A pharmaceutical manufacturing entity in Botswana is looking for talent to take up the position of Quality Assurance Manager and become an integral part of a vibrant, high performing team.

Job Purpose

The purpose of this role is to lead the continued development, implementation and maintenance of the quality management system supporting the production and development of good quality medicines and medical products, in accordance with the Botswana Medicines and Related Substances, national and regional guidelines and policies.

Main duties

Reporting to the Plant Head, the QA Manager will oversee and assume responsibility for all quality assurance activities on site.

Specifically, the incumbent will

• through leadership of a small team at unit level, be responsible for providing technical and operational strategic direction to the quality assurance portfolio.

• interface and work closely with the Heads of Production and Quality Control and other support functions such as Engineering, Research & Development and Procurement and be responsible for effective QA support of cross-functional activities and coordination of the same.

• identify and establish appropriate quality standards, specifications and parameters for products; and communicate the quality standards and parameters to the QA team and other appropriate staff to ensure adherence and implementation

• write, revise and approve standard operating procedures for the facility, as necessary. The incumbent shall also support document control functions

• provide quality oversight for product manufacturing activities including review of executed batch records, batch release and change control processes associated with manufacturing activities

• lead investigations related to product manufacturing activities, product marketing information and complaints, and non-compliances.
• support the Regulatory Affairs function, and where necessary, liaise with BOMRA, the national regulatory Authority.

• provide regular reports to   the Plant Head and Regional Regulatory Affairs Head on the functioning and regulatory performance of the facility

Qualifications and Experience

A Bachelor’s Degree in Pharmacy or a relevant Science Degree with at least 5 years working experience. The incumbent must

• have a working knowledge of cGMP. Experience in health products manufacturing or regulation environment will be an added advantage.

• have the ability to pay attention to detail, prioritize work and handle multiple assignments

• demonstrate management ability and leadership, and potential to drive technical quality strategy implementation. Previous management experience will be a distinct advantage.
• have excellent verbal and written communication skills.
• Experience in conducting training will be a distinct advantage.