Analyst Midrand - Midrand
A pharmaceutical company in Midrand is looking for a validations analyst to join their team. Lead validation and calibration activities for a GMP complementary medicine and cosmetic 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 new equipment purchases within the facility to determine 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. Develop, write and update 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. Required skills: Excellent organising and planning skills. Meticulous attention to detail. Excellent written and verbal communication skills (English). Computer literate (MS Office). Ability to work independently and as part of a team. Good interpersonal skills. Ability to work under pressure and meet deadlines. Good physical health. Knowledge of GMP requirements / guidelines will be advantageous. Bachelor degree in Engineering/B.Tech/S4/B.Eng/BSC or Pharmacy/Science Degree. 1 Year experience in a similar role in a pharmaceutical or cosmetic manufacturing environment. Market related Pension Fund
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