- Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in the pharmaceutical industry in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures).
- Develop and execute the validation master plan, validation project plan, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations.
- Generate the User Requirement Specifications and Impact Assessments to ensure the functioning of the equipment and determine the impact of the system on the product quality.
- Perform design review to ensure the equipment is installed and operates according to the User Requirement Specifications.
- Perform Commissioning, Qualification and Validation of the equipment and systems.
- Generate and execute validation protocols (IQ, OQ and PQ) for pharmaceutical drug manufacturing and laboratory equipment, including but not limited to HEPA filters, controlled temperature units, manufacturing equipment and packaging line equipment.
- Characterize equipment operation processes and define critical process parameters and critical quality attributes
- Write and execute the official test scripts, complete associated documentation for equipment and processes to ensure the test results are reported accurately.
Job Types: Contract, Full-time
Pay: $30.00 - $45.00 per hour
Schedule:
Education:
Experience:
- Manufacturing: 1 year (Preferred)
Contract Length:
Contract Renewal:
Work Location:
Company's website:
Work Remotely:
Work Location: Multiple locations