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Senior Validation Analyst (Pharma). Pretoria. R25k to R30k p/m, neg. - South Africa

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An established pharmaceutical manufacturing company has an opportunity for two Validation Analysts to join their team. Ideally, one more experienced analyst (3 to 4 years' experience), and one more junior analyst (1 to 2 years of experience). This position will report to the QC (Quality Control) Manager. NOTE - For now, the positions are on an 18-month contract. There is a possibility that the positions may become permanent. Required: Someone who can 'hit the ground running' - to start asap in a GMP environment, doing Analytical Validation, including stability samples and validation testing. And perhaps to stand in as Acting QC Manager from September too. Job functions:  Lead validation and calibration activities for a GMP pharmaceutical and API manufacturing facility.  Develop protocols for executing equipment and facility qualifications (DQ, IQ, OQ, PQ), process validations, method validations, computer system validations, HVAC validations, water system validations, cleaning validations and temperature mapping studies.  Execute protocols, including coordination of activities with other departments, hands-on performance of protocol requirements, data analysis and final report writing.  Provide detailed review of calibration and validation failures, using good investigative technique and risk-based evaluations.  Champion continuous improvement activities in the validation function at the facility that will lead to increased reliability in equipment and processes.  Maintain accurate tracking of validation studies, equipment and facility status.  Review all operational, cleaning, maintenance, validation and calibration requirements.  Determine calibration needs of equipment and establish calibration procedures, tolerances, and schedules based on criticality of application and following good calibration/metrology-based evaluations.  Maintain departmental SOPs.  Provide subject matter expertise in the assessment of manufacturing deviations and investigations, change control submissions, new product development and during regulatory and customer inspections.  Maintain temperature and humidity monitoring of factory, scales and laboratory equipment.  Relevant qualification e.g. - Bachelor degree in Engineering/B.Tech/S4/B.Eng/BSC or Pharmacy/Science Degree.  At least 2 years of Validation Analyst experience at a pharmaceutical manufacturing company, or at a chemical company that produces pharmaceutical products. Salary will vary based on seniority in Validation, specific experience and qualifications etc. Senior VA salary R25k to R30k (negotiable). Junior VA salary R20k to R25k (negotiable) NOTE - 18-month contract position, for now. Apply Now
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