*Prior experience in the injectable product is required*

Location – Richmond, VA

Job Description:

This position is crucial in the startup of manufacturing at Petersburg, VA site. The person is responsible for reviewing validation documents for manufacturing equipment and processes.

Responsibilities:

• Oversee and participate in the execution of IQ/OQ/PQ protocols, ensuring that equipment, systems, and processes meet predefined acceptance criteria.
• Review validation deliverables, including but not limited to URS, DQ, IQ, OQ, PQ, RTM, and Summary Reports.
• Follow validation processes and, if required, initiate deviations and CAPAs to ensure compliance.
• Provide oversight to the entire QA Validation process for continuous improvement.
• Review discrepancies during protocol execution and guide the team on good documentation practices.

Qualifications:

• Bachelor’s degree in a scientific discipline with a minimum of 5 years Quality/CGMP experience in the pharmaceutical industry.
• Experience in sterile injectable manufacturing and packaging operations is required.
• Strong  organization, and execution skills with a proven track record of shop floor manufacturing.
• Quality assurance experience across the product development and commercialization lifecycle including.
• Participation and leading activities to support regulatory agency inspections required.