munyaradzi kaiya

QC Chemist Lead / Manufacturing Process Scientist

• Job Details:Execution of preformulation, formulation development and manufacturing development studies for generic products and reformulations using principles of generic pharmaceutical development and good manufacturing practice. Perform various types of testing using chromatographic systems, various wet chemistry analyses, HPLC, IR, FTIR, GC, AAS apparatus. Execute specialized analyses and method transfer and feasibility testing. Document work as required for GMP compliance. Perform tests accurately. Troubleshoot method and instrumentation problems. Use office and instrumentation specific computer software. Produce written reports (e.g., SOP, protocols, client reports). Develop and execute validation plans. Participate in tech and method transfer. Train technical staff. Generate and execute qualification and re-qualification protocols and reports (IQ/OQ/PQ/RQ) for the validation of new and existing equipment and utilities. Analyze data with respect to standards or to previously determined parameters. Maintain a safe, organized work environment according to lab specific procedures maintaining work instructions. Perform other related duties as required.

Snr R & D Officer - Validations

• Job Details:Participating in registration of Alpha Mertfomin tablets, Paracetamol tablets, Betaflex syrup, Betaflu syrup and Betamine Plus syrup for Zimpharm 2024. Execution of preformulation, formulation development and manufacturing development studies for generic products and reformulations using principles of generic pharmaceutical development and good manufacturing practice. Perform various types of testing using chromatographic systems, UV/Spec, various wet chemistry analyses, HPLC, IR, auto-titrators, TLC, and dissolution apparatus. Execute specialized analyses and method transfer and feasibility testing. Document work as required for GMP compliance. Perform tests accurately. Troubleshoot method and instrumentation problems. Use office and instrumentation specific computer software. Produce written reports (e.g., SOP, protocols, client reports). Develop and execute validation plans. Carry out method transfers and feasibility studies. Train technical staff.

Validations Specialist / Supervisor

• Job Details:Generate and execute qualification and re-qualification protocols and reports (IQ/OQ/PQ/RQ) for the validation of new and existing equipment and utilities. Generate, coordinate and implement process, analytical and cleaning validation activities. Develop acceptance criteria consistent with industry standards, manufacturer recommendations, user and functional specifications, and current good manufacturing practices (cGMP). Generate summary reports, following good documentation practices. Use data loggers for environmental and temperature mapping studies. Generate/revise standard operating procedures (SOPs). Analyze data for adherence to acceptance criteria. Documentation/resolution of deviations associated with qualification studies. Generate technical documents such as reports, gap analyses, risk assessments and CAPAs. Provide technical and/or investigational support in troubleshooting and resolving manufacturing equipment issues. Perform technical review of qualification documents performed by others. Support services to prepare for audits. Provide QA review of executed validation documents such as change controls, protocols and test plans, validation testing documents, and deviations. Ensure compliance to governing SOPs, validation plans, and protocols throughout the project. Release equipment and/or instruments for GMP manufacturing and/or quality control use as part of change control. Assess impact and re-testing requirements in the event of a deviation. Participating in trainings of personnel on validation concepts as per QA calendar.