Location: Rensselaer, NY
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.
- 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