An opportunity has become available for a suitably qualified and experienced Responsible Pharmacist with manufacturing experience. This is a junior to intermediate position based in Johannesburg

Job Description:

Ensuring any pharmaceutical activities related to products are performed in compliance with local SAHPRA regulations and international requirements if necessary

Responsibilities include:

• Ensuring quality governance and quality planning through the establishment and implementation of the quality policies and SOPs, quality risk management plans, technical agreements etc.;
• Controlling the packaging of products including the specification, sampling, release and approval;
• Performing line clearance and in-process checks;
• Planning and executing an annual GMP and QA training program;
• Performing and reporting on internal audits thus ensuring the adequacy of the Quality Management System;
• Assuring continuous quality system improvements in order to maximise its efficiency;
• Managing appropriate quality contracts or service level agreements with sub-contractors as required;
• Performing supplier/sub-contractor audits;
• Sampling, co-ordinating any external tests by third parties whilst ensuring that they are performed in accordance with GMP guidelines;
• Preparing or auditing certificates of analysis and conformance of semi-finished and finished goods;
• Attending to and investigating out of specification results, product complaints and recalls;
• Responsible for maintaining a controlled substance register and reporting to the SAHPRA on quarterly quantities as well as attending to any queries or investigation in this regard;
• Applying to the SAHPRA for Section 22A permits (import/export of controlled substances) on behalf of the company
• Ensuring company objectives are met whilst complying with all relevant legal requirements

Minimum Requirements:

• Pharm degree
• Registration as a pharmacist with the South African Pharmacy Council (internship and community service completed in South Africa)
• Proficient computer skills in Ms Office, Word, Excel and PowerPoint
• Minimum 2 years of experience preferably in a manufacturing facility. If not, in a hospital setting.
• Experience and proficiency in pharmaceutical calculations and implementing and monitoring quality management systems.
• Experience in applying to the SAHPRA for permits is beneficial.