VALIDATION PROCESS ADMINISTRATOR IN SOUTH AFRICA

Our client in the Pharmaceutical industry based in Gauteng is looking to employ a Validation Process Administrator. Requirements: • Min of 2 yrs proven experience in a pharmaceutical validation / qualification position. • Knowledge and or experience in supply chain logistics. • Knowledge and or experience in lean and six-sigma manufacturing. • Knowledge and or experience in current ISO 9001 and ISO 13485 standards. Must have knowledge in: • TrackPro. • Cold Chain ThermoDynamics. • Eurotherm. • Metasys. • Sensitech. • PlantVisor PRO. Purpose of Job: • Validation/qualification of all GxP-critical systems within the company. • Maintaining the status of current systems and validating/qualifying new systems. • Managing an environmental chamber as an internal asset and as external business instrument. • Providing general expert validation/qualification assistance and information to internal and external stakeholders. • General office assistance in the Validation Department and assistance with budgeting. Duties: Validation/Qualification Activities: • Incl. facilities (warehouses/fridges/freezers), cold chain boxes & vehicles (nationally to all branches). • Compiling validation/qualification (DQ / IQ / OQ / PQ / CQ / Mapping) protocols. • Performing validation / qualification testing as per approved protocols. • Documenting results in validation/qualification reports. • Tracking and conducting periodic reviews of all validation/qualification documents. • Tracking and conducting periodic temperature/humidity remapping of systems. • Managing long-term, on-going PQ data collection. • Revalidation/requalification of systems as required. • Managing storage of physical and electronic validation/qualification documents. • Development and testing of new cold chain packaging solutions and documenting outcomes. • Validation / qualification of any new infrastructure/equipment needed. • Participation in audits and resolution of CAPAs. Management of Environmental Chamber and Ancillary Equipment: • Daily running of the chamber to ensure optimal functioning. • Good housekeeping of the chamber / fridges / freezers and surrounding areas. • Contacting vendors for maintenance/repairs/upgrades to chamber/probes/software. • Arranging timeous calibration of chamber probes and filing documentation. • Liaising with customers and preparing quotes/invoices for rental of the chamber. • Physically assisting customers with testing and providing data/certificates. • Scheduling testing activities and customer bookings optimally. Management Of Validation/Qualification Measuring Instruments: • Arranging timeous calibration, capturing information, filing certificates. • Providing instruments to other departments and track their return. • Pre- and post-calibration of instruments. Other Duties: • Compiling relevant processes and work instructions and perform training. • Assisting internal departments / clients / customers with relevant validation/qualification information. • Ad hoc projects for clients / customers such as special temperature monitoring etc. • Managing Contractors and Consultants as required. • Assisting with budget preparation by calculating validation / qualification needs and obtaining quotes. • General office administration – obtaining quotes / generating POs / ordering consumables etc. • Mentoring of the departmental assistant/learner. Salary: R 29 000 CTC Includes Benefits To apply email CV’s to resumes@dmgpersonnel.co.za Please note that only short-listed candidates will be contacted