Full Time
New York
Posted 4 years ago

Location: Rensselaer, NY

Interview: Phone/Skype

Start date: 10/01

Category : Full Time

  • Qualify equipment based on cGMP (Good Manufacturing Practices) standards.
  • Author and execute validation protocols for IQ, OQ, and PQ for the equipment as well as utilities, HVAC’s and facility.
  • Review the Installation & Operational Qualification procedure of the newly installed Air Handling Unit (AHU) and generated the final qualification reports.
  • Handle Kaye Validator 2000 and Kaye AVS for temperature mapping studies for autoclave, incubator, refrigerator, cold rooms and walk-in freezer.
  • Perform regular CIP and COP related to tanks, parts washers and manual cleaning equipment.
  • Involve in execution support for utilities like CDA, pure steam, WFI.
  • Perform IQ, OQ, and PQ of fully automated CIP skids for cleaning
  • Review and document batch records, supporting documents, equipment logbooks and SOPs
  • Assist in development of Quality Control Systems in compliance with Part 820 of CFR Part 11.
  • Perform drawing verifications for all utilities in different building facility and verified them as requirements for the company.
 Minimum requirements:
  •  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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