COMMENCEMENT: ASAP
Purpose Of Position
Provide Quality Assurance support throughout the compounding center to ensure that the quality of products produced consistently complies with the GMP and regulatory requirements and will be safe and effective to the end user.
Minimum Requirements
- Matric
- Pharmacist assistant course
- Previous employment within a Production or QA pharmaceutical manufacturing environment.
- Work experience in a sterile environment preferred.
- Computer literacy (MS Office, Internet)
- Thorough knowledge of cGMP principles
- Outstanding communication skills (verbal and written) fluent in English.
- Be available for duty after hours and on required Production weekends to complete related QA-IPQC duties until production is completed.
- To support the QA TPN Release Pharmacist to ensure continuous change and adaptation of systems in line with new rules and regulations.
- Perform daily walkabouts in the compounding center and reporting to the QA TPN Release Pharmacist / Production Pharmacist.
- Ensure that validations are carried out and media fills are performed as per SOP and according to the yearly schedule.
- Checking production paperwork is completed correctly and checking of acid solution dilutions.
- Ensure the compounding process is followed as per approved SOPs.
- Ensure equipment that is utilized in the Compounding Center is within calibration.
- Record drop test information daily and observe leak tests when performed.
- Approve bio-decontamination cycles to start by verifying all the pre-bio-decontamination checks.
- Authorize the off-loading of product from transfer isolators and emergency drums by checking the time the solution was drained, the remaining acid solution and acid condensate and calculating the acid vaporization rate.
- Ensure checked documentation is fully complete.
- Monitor the pressure for all isolators throughout the production processes.
- Perform regular daily audits on transfer isolators, emergency drums and waste bins to verify that docking procedures, off-loading of components, care of the equipment, pressure requirements and GMP standards are maintained as per SOP.
- Checking of BMRs and BRLS in line with production planning for correct Expiry date etc.
- Ensure appropriate filing of all QA log sheets and that the filing is up to date.
- Correct filing/archiving of production records and maintain record stores.
- Ensure GMP adherence and staff training.
- The ability to recognize opportunities for new services and products and to act accordingly, taking measured risks into account
- Strategic Orientation
- Leadership Competency
- Planning & Organizing
- Communication and negotiation
- Professional Competency
- Innovative
- Adaptability/Flexibility
- Social and Intercultural Competency
- Conflict Management
- Note: A Comprehensive list of all duties and responsibilities will be disclosed to / discussed with short-listed candidates.
iSanqa is your trusted Level 2 BEE recruitment partner, dedicated to continuous improvement in delivering exceptional service. Specializing in seamless placements for permanent staff, temporary resources, and efficient contract management and billing facilitation, iSanqa Resourcing is powered by a team of professionals with an outstanding track record. With over 100 years of combined experience, we are committed to evolving our practices to ensure ongoing excellence.
