Skills

  • Processes Validation
    10
  • Equipment Qualifications
    10
  • Quality Management system
    9
  • 9
  • APQR
    10
  • Product management
    8
  • Cleaning Validation
    8
  • Internal and External Audits
    8
  • English and Kiswahili
    10

Experience

james onjula

Work experience
  • ▪ Monitoring, evaluation, and auditing of manufacturing and operation processes
  • ▪ Carrying out internal and external audits
  • ▪ Preparation, review, and execution of validation protocols and reports in collaboration with the regulatory affairs, Engineering, Quality Control, and Production departments
  • ▪ Carrying out annual product quality review
  • ▪ Carrying out IQ/OQ/PQ for all new equipment
  • ▪ Track corrective and preventive action taken to ensure the company continues to deliver the highest standards to its customer expectations and needs
  • ▪ Preparation/Revision of SOPs, BMRs, issuance, and destruction of Obsolete SOPs, ensuring Formats are available and updated
  • ▪ Training of staff on current good manufacturing practices and orienting of new recruits
  • ▪ Preparation, review and execution of validation protocols and reports in collaboration with the regulatory affairs department

james onjula

Education
  • September, 2015 - November, 2019
  • Fulltime
  • Pharmaceutical Chemistry
  • Analytical methods
  • Spectroscopic methods

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