QA Manager and Responsible Pharmicist
4 days ago
**QA MANAGER & RESPONSIBLE PHARMACIST - Cape Town**
**MAIN PURPOSE**:
- To ensure that the organization complies with all the mandatory requirements as a holder of a licence to Manufacture, Import or Export Medicines.
**JOB OBJECTIVES**:
- Act as the Responsible Pharmacist for the company.
- 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.
- 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.
- To support the decision-making process in all matters that affect the quality of products as well as the pharmacy business
**JOB REQUIREMENTS**
**Job Knowledge**:
GWP/ GDP/ GMP
- Pharmaceutical industry laws, regulations and ethics (Medicines and Pharmacy Acts, Marketing Code).
- Other related industry laws, regulations and ethics (CPA, Companies and Competition Acts).
- SAHPRA Codes.
- Business Processes.
- Knowledge of Pharmaceutical Manufacturing,
- Wholesale/ Distribution and Quality Assurance and Quality Management.
**Job Related Skills**:
- Policy and procedure development skills.
- Communication skills, both verbal and written.
- Project management skills.
- Presentation skills.
- Computer skills.
- Commercial thinking and business acumen.
- Networking and relationship building skills.
**Job Experience**:
- 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**:
- BPharm Degree with current valid registration in good standing with SAPC.
- Quality Assurance Qualifications (Quality Assurance Manager Certification, ISO Internal Audit Certification).
- Medicine Registration Course.
**Essential Competencies**:
- Leading and Supervising.
- Supporting and Cooperating.
- Interaction and Presenting.
- Analysing and Interpreting.
- Organising and Executing.
- Adapting and Coping.
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