Full Time
Kansas
Posted 9 months ago

Location: McPherson,

KSInterview: Phone/Skype

Start date: 10/01

Category : Full Time

  • Author and execute validation protocols for IQ, OQ, and PQ for the equipment as well as utilities, HVAC’s and facility.
  • Ensure that the development and maintenance process are adequate in order, for the system to meet its objective.
  • Responsible for document preparation and execution of validation protocols for a wide range of manufacturing equipment.
  • Review validation deliverables to assure compliance with 21 CFR Part 11 (Electronic Signatures and Records) and FDA Regulations.
  • Qualify the equipment based on cGMP (Good Manufacturing Practices) standards.
  • Review Laminar & Terminal HEPA filter certification performance qualification procedures.
  • Author and executed Qualification Protocols for HVAC’s, Freezers and controlled temperature units.
  • Assist in development of Quality Control Systems in compliance with Part 820 of CFR Part 11.
  • Qualify parts washer by following cGMP standards and using advanced quality control techniques.
  • Review the Installation & Operational Qualification procedure of the newly installed Air Handling Unit (AHU) and generated the final qualification reports.
  • Qualify parts washer by following cGMP standards and using advanced quality control techniques.
  • Conduct thermal mapping studies using Data Loggers and Kaye Validator.
  • Work along with the production team to increase the Quality standards of the product filling line and validation related activities.
  • Author and Initiator of Events and Quality Assurance Reports in Global Quality tracking system using Track wise.
  • Initiate Work orders and Action Items using EAMS
 

Minimum requ​irements:

  •  Bachelor’s in Pharmacy or Equivalent is required
  •  1-5 years relevant experience
  •  Strong technical writing to develop client SOPs
  •  Excellent communication skills
  •  Excellent attention to detail, analytical and problem-solving skills
  •  Experience in writing IQ, OQ and PQ protocols
  •  Knowledge of GMPs, GDPs, GLPs

Job Features

Job CategoryPharmaceutical

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