Job Description
Senior project lead
Job Summary
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Location: New Jersey
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Project role: Senior project lead
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Skills: Computer System Validation (CSV)
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No. of positions: 1
Job description:
Pharma ManufacturingResearch, Computer System Validation " 10+ years of Business analyst experience in research, development, or manufacturing function of pharmaceutical companies. At least 3+ years of experience in Pharma quality management systems like RiskComplaints/Audit management, etc. Experience using ETQ Reliance QMS preferred. Experience with TrackWise, Veeva or other QMS solutions would be a plus Hands on experience with building Requirement Specification, Data mapping, Validation documentation, Operational Qualification Protocols, Performance Qualification protocols., SOPs, Work Instructions. Experience around SDLC documentation applicable to Life sciences Knowledge of pharmaceutical/medical device regulations like GxP, FDA 21 CFR Part 11, 210,
- Ability to interact with business and IT stakeholders and bring in best practices in Pharma manufacturing. Strong understanding of quality management systems operations with an ability to fill the gap between business users and technologists Ability to work independently with minimal supervision. Ability to plan for, coordinate, and conduct reviews of project deliverables for completeness, quality, and compliance with established project standards "
Disclaimer
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