Quality Assurance & Regulatory Pharmacist

SUMMARY:
Quality Assurance & Regulatory Pharmacist

POSITION INFO:

Job Overview

Our Company is currently seeking for a Quality Assurance & Regulatory Pharmacist to manage compliance with the Medicines and Related Substances Act, Act 101 of 1965 as amended and the Pharmacy Act, Act 53 of 1974 as amended, and any guidelines promulgated in terms of these Acts, as relates to the distribution and wholesaling of Medicines (as defined in the Act) for the Company. To execute fully the responsibilities and duties of a Pharmacist, as set out in Regulation 28 of the regulations relating to the practice of Pharmacy, in the Pharmacy Act.

Key Performance Areas

• To ensure licensing of all activities with SAHPRA, Department of Health and Pharmacy Council, and to ensure maintenance and upkeep of such licensing
• To ensure compliance with both the Medicines and Related Substances Act and Pharmacy Act
• To ensure the practice of the business under the auspices of the marketing code of conduct
• To control the procurement, transport, storage, and distribution of final product and all associated components in accordance with GDP/GWP
• Ensure all company policies, procedures, and work instructions are documented in a clear, simple and concise manner
• To control practice through the implementation of SOPs and feedback through assessment systems
• To control the fate of medicines; i.e. handling of rejects / returned medicines & medical devices
• To address quality related complaints
• To address continuous improvement through the application of risk management, corrective and annual reviews
• To maintain overall responsibility for all company advertising of medicines and medical devices
• To maintain responsibility for investigating, recording, handling and reporting of medicine/ medical device complaints and adverse reactions
• To oversee all areas of Wholesale including returns and recalls
• Conducting self-inspection audits, conducting staff training, and preparing for audits by third parties 
• To perform the functions of a pharmacist to enable the company to ensure that there is continuous Pharmacist supervision of premises during operating hours
• Staff training  
• Ensure that processes needed for the Quality Management System (QMS) are established, implemented and maintained
• Ensure that contracts exist between the wholesaler (contract giver) and third party contractors (contract acceptor) stipulating where all the responsibilities in terms of GWP lie
• Report to top management on the performance of the QMS and any need for improvement
• Ensure the promotion of awareness of customer requirements throughout the organisation

Qualifications and Experience

• B Pharm Degree
• Registration with the South African Pharmacy Council (SAPC)
• Must have experience of GDP and GWP
• SOP Preparation
• Staff Training
• 2 years’ experience in a wholesale, distribution or production environment

Desirable

ISO 9000: 2015 knowledge

Personal Skills / Attributes

• Ability to develop strong working relationships
• Meticulous, accurate and a high level of attention to detail
• Computer skills on MS Office (Word and Excel)
• Planning and prioritizing
• Ability to multi-task, to work under pressure and meet deadlines
• Ability to work effectively cross-functionally
• Self-motivated, pro-active
• Creative thinking, problem solving
• Results oriented
• Compliance oriented
• Role model of the values and leadership attributes
• Systems understanding
• Business Acumen
• Communication Skills
• Conflict management skills

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