Quality Assurance Pharmacist – Medswana

Job Description

Medswana (PTY) Ltd is seeking a Quality Assurance Pharmacist (QAP) to be based in Gaborone. The QAP will manage the design and implementation of efficient and effective Quality Management Systems (IS013485) in the warehouse and report to the QA & RA Manager. She/he will ensure that quality assurance and quality control (QA/QC) processes are in place and maintained by strict compliance to SOPs throughout the warehouse.

The warehouse is run in accordance with WHO Guide to Good Storage and Distribution Practices and follows WHO Model Guidance for the Storage and Transport of Time and Temperature Sensitive Pharmaceutical Products, and the WHO Technical Supplements to Model Guidance for the Storage and Transport of Time and Temperature Sensitive Pharmaceutical Products

Key Skills: Quality Management Systems, Analytical and Commodity Management Skills, ISO 13485.

Duties:

• Collaborate in the design and implementation of efficient and effective Quality Management Systems (QMS), ISO 13485 in the warehouse.
  Ensure that quality assurance and quality control (QA/QC) processes are in place and maintained by strict compliance to SOPs throughout the warehouse.
• Review periodically to ensure that all standard operating procedures reflect the most up-to-date, internationally accepted practices in accordance with GMP, GDP, GWP and EHS and ensure compliance with evolving innovations or changes to processes or products.
  Ensure the compliance of the warehouse to Environment, Health & Safety as well as Good House Keeping Practices.
• Drive the Change Control and Deviations Process by ensuring appropriate documentation (e.g., Change Control Documentation and Non-Conformance Logbook)
  Conduct self-inspections in conjunction with the Warehouse Manager according to required standards (GDP/GWP/ ISO 13485).
• Compile reports with suggested CAPA (NC) and ensure its implementation within required timelines.
• Organize and manage training matrix for all warehouse personnel. Ensure that training is conducted for all new SOPs with periodic refresher training.
• Ensure that Temperature Reports, Pest Control Reports, Maintenance Reports, Housekeeping Reports and Incident Reports are kept up to date.
  Undertake the inspection and sampling of commodities in accordance with relevant SOPs or Client requirements.
• Organize biannual self-inspection and annual internal quality inspection to ensure the warehouse is always in an audit-ready state.
• Provide leadership in the management of cold chain products.

Qualifications:

• A degree in pharmacology
• Licensed pharmacist in Botswana
• Minimum two years’ experience in quality assurance functions in a warehousing and distribution or manutacturing setting, advantageous.
• Understanding of common pharmaceutical warehousing standard
• Experience in capacity development and delivery of trainings

General Attributes:

• Highest degree of personal and professional integrity, honesty, and ethics.
• Continuous quality improvement mindset.
• Leadership by example orientation.
• Actively engage with QA & Regulatory manager.

Closing Date: is 7th July 2023