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Principal Specialist – Quality Validation
JSR Micro, Inc.. Ensure the quality of IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting .
About the role
Key responsibilities & impact- Ensure the quality of IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting
- Review and approve enterprise software validation lifecycle deliverables
- Provide global oversight of enterprise software validation
- Review and approve enterprise software change controls, CAPAs, and deviations
- Support the global data integrity initiative
- Provide strategic and technical expertise on global software validation matters
- Ensure compliance with cGMPs, legal and regulatory requirements, and KBI internal requirements
Requirements
What you’ll need- BS and 8+ years’ experience or MS and 6+ years’ experience in a QA or GMP environment or equivalent
- Experience in Data Integrity, computer system validation, and IT quality in an FDA regulated manufacturing environment
- Demonstrated expert knowledge of 21 CFR Part 11 and/or EU Annex 11
- Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, and governmental regulations
- Ability to write reports, business correspondence, and procedures
- Ability to present information and respond to questions from staff, colleagues, managers, and clients
- Ability to read, analyze, and author complex documentation
- Ability to solve practical problems with limited standardization
- Ability to interpret written, oral, diagram, or schedule-based instructions
Benefits
Comp & perks- EEO/AA employer committed to workforce diversity
- Approximately 10% domestic and international travel