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
Ensuring any pharmaceutical activities related to products are performed in compliance with local SAHPRA regulations and international requirements if necessary
- 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
- 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.
Only shortisted candidates will be contacted