Clicks Group

JOB PURPOSE To ensure that Unicorn Pharmaceuticals complies with all the mandatory requirements as a holder of a licence to Manufacture, Import or Export Medicines

• Act as the Responsible Pharmacist of Unicorn Pharmaceuticals.
• Ensure that the organisation meets its statutory obligations in terms of the SA Pharmacy Act 53 of 1974 and the Medicines and Related substances Act 101 of 1965 as amended.
• Manage external service providers in all quality-related aspects during the life cycle of a contract.
• To ensure international and local supply and manufacture of products/services is of acceptable quality, in full regulatory compliance and in accordance with the contractual obligations and SAHPRA guidelines.
• To maintain Good Manufacturing Practice standards and conduct annual training for all relevant employees.
• Ensure that all relevant quality assurance functions are carried out in accordance with current company policies and procedures and government regulations:
• To evaluate the required documentation by ensuring that there is compliance with the conditions set out in the authorisation or certificate of registration before a batch is released for sale.
• Develop and implement a Quality Management System (QMS) that is sustainable.
• Identify and recommend opportunities for continuous improvement to enhance the QMS.
• Escalate critical information that may impact product quality, safety and competence to senior management for further action.
• Maintain a high level of professionalism and commitment to quality development.
• Be up-to-date of changes in the pharmaceutical industry and provide the necessary guidance to the business to ensure compliance with regulatory requirements.
• Managing relationships with SAHPRA
• Ensuring QMS is managed effectively and timeously

EXPERIENCE

Essential

 10-15 years Pharmaceutical

industry experience (Quality

Assurance, Manufacturing,

Wholesale and Distribution)

 Experience working in a

compliance environment in the

pharmaceutical industry

 Business management

experience

 People management experience

 Department Head /Managing a QA

department experience

EDUCATION

(specify the minimum level of formal education and /or any other certification, accreditation or registration)

Essential Desirable

 B. Pharm Degree with current valid

registration in good standing with

SAPC

 Quality Assurance Qualifications (Quality

Assurance Manager Certification,

ISO Internal Audit Cerification)

 Medicine Registration Course

 MBA