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Roodeplat

Quality Management System development , implementation and maintenance as per ISO 9001:2015, OECD GLP and VICH GCP as well as WHO and CDC biosafety requirements.Implementation of Deltamune policies and procedures to ensure that all appropriate quality requirements are met for product development projects within Product Development.Ensure that all personnel are inducted into Quality System principles related to their own roles and responsibilities. Ensure that all personnel are inducted into biosafety principles as required by DALRRD related to their own roles and responsibilities. Provide update training as necessary.Provide appropriate training for all staff on the use of any updated quality system as required.Responsible for the administration of the equipment control system for the Product Development Department.Responsible for the planning and scheduling of quality assurance monitoring programmes in relation to study plans including facilities.Performing system or facility-based inspections.Responsible for documenting and reporting of all inspections performed.Co-ordination for audits of study data and final reports to ensure, with the assistance of a specialist as required.Investigate, recommend and implement an appropriate Documentation System to support the Quality SystemResponsible for the document control of the Product Development Department.Maintain copies of all approved study plans and related Standard Operating Procedures (SOP’s).Responsible for the review of SOP’s before use to assess their clarity and compliance with Quality System Principles.QA inspections of suppliers and contractors.Provide feedback on QA performance and any needs for improvement.Establishment, implementation and maintenance of all the facility requirements, procedures and processes needed to comply with DALRRD biosafety requirements for the research & development department.Perform biosafety facility internal audits.

Randburg, Gauteng, South Africa

Responsible for coordinating and allocating work to the laboratory staff.Execute laboratory work timeously, ethically and efficiently.Adhere to safety, health, environment and quality policies and instructions.Supervision of duties of laboratory staff and to assist where necessary with difficulties encountered in terms of calculations and preparations.Coordinate the on-going stability programme.Responsible for all waste generated in the laboratory and to dispose of it in a proper prescribed mannerEnsuring proper housekeeping is adhered by all laboratory staff and ensuring that all laboratory results are released to clients on time.Maintain the principles of GLP and quality assurance standards in accordance to company policies.Scheduling and completion of regular internal audits as well as preparing for external audits.Conducting trend analysis and evaluating practical aspects of the laboratory`s quality system.Investigating and reporting of OOS`s and non conformances followed up afterwards to ensure that implemented corrective actions are effective and adhered to.Checking of laboratory reports, creating COAs and release of results.Ensures that all laboratory equipment is maintained and calibrated regularly following the relevant standard operating procedure.Writing , reviewing and updating of SOPs.Maintain a suitable control system, ensuring analysis, document, standard and equipment traceability.Overseeing training records of all laboratory staff and see to it that new and existing staff are signed off competent for any new or revised policies or procedures, test methods and corrective actions.

Kya Sands, Randburg

• Plan, prepare and supervise laboratory services.• Responsible for maintaining the laboratory equipment and hardware, making sure it is properly cared for, performing maintenance and repairs, and replacing equipment when necessary. • Set up equipment and tools for testing, including calibrating equipment and instruments and testing them to make sure they’re functioning properly. • Maintain inventory levels and appropriately organize and label all supplies and equipment, and ordering of laboratory consumables, schedule service and calibration of laboratory equipment timeously.• Perform regular tests timeously in accordance with ASTM requirements and company methodology and in accordance of lab quality systems (ISO 17025 and ISO 9001)• Report tests onto the laboratory system on SAP, Monthly monitoring laboratory reports on MS excel. • Prepare and organize all results data and findings, inputting all data in necessary files and systems and creating documents and presentations to communicate results with other staff members.• Coordinates training and ensures that adequate knowledge regarding testing procedures and laboratory protocol is obtained.• Keep up to date with relevant scientific and technical developments in the field, SOPs (Standard operating procedures) and document control in the laboratory.• Responsible for producing certificates of analysis for finished products, filing and maintaining laboratory records for traceability.• Recommend correction for re-work on non-conforming products to the specifications required and ensuring the steps are taken to rectify the problem.• Currently developing and implementing a laboratory management system according to ISO/IEC 17025.• General laboratory management and good laboratory practice.

Randburg, Johannesburg

• Plan, prepare and supervise laboratory services.• Ensure all incoming samples are recorded and tested in accordance with customers request.• Support director with laboratory activities.• Training all junior laboratory staff as required.• Checking and reporting of results ensuring that the raw data and transferred results are authorised.• Head responsibility to main laboratory records, reports and files.• Maintain quality assurance standards in accordance with company policy.

Randburg, Johannesburg

• Prepare reagents and control according to prescribed procedures• Testing of pharmaceuticals products as per company methodology and in accordance of lab quality systems (ISO 17025 and ISO 9001)• Validates and reports results produced by the laboratory• Accurate analysis of samples using analytical instruments (HPLC, GC, UV, IR, AAS).• Perform dissolution tests, physical and analytical tests using Karl Fischer, auto titrator, pH meter, disintegration tester and hardness tester.• Conduct lab activities according to SOPs and protocols, and in accordance with confidential agreements.

Postgraduate Degree, Quality Management

Bachelor Of Technology - Btech, Quality

National Diploma In Analytical Chemistry, Analytical Chemistry