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- In depth knowledge of the requirements for Computerised Systems and supporting system design.
- Full interpretation of GAMP 5, EU GMP Annex 11 - EudraLex Volume 4 - EU guidelines to Good Manufacturing Practice - Products for Human and Veterinary Use, Annex 11: Computerised Systems. [21 CFR Part 11] Food and Drug Administration Code of Federal Regulations - Electronic Records, Electronic Signatures, Final Rule. General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
- Competent at coaching, oversight & decision making on complex CSV issues and associated support systems. You show strong leadership skills and demonstrate the ability to work in cross-functional teams.
- You are trained as a GMP auditor to support internal GxP audits of computerised systems.
- Lead qualification of (MES) Manufacturing Execution System and associated outbound and inbound system
- * Maintain validation philosophies, master plans and procedures required to drive the validation lifecycle of production recipes
- Work in conjunction with Validation team, Production, Manufacturing Engineering and Quality Assurance to manage program and strategies aligned with site validation philosophies
- Establish validation plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with stakeholders
- BS in Computer, engineering, mechanical, electrical engineering, chemical bio-engineering or relevant discipline is required
- Minimum of 5 + years of experience with MES (Manufacturing Execution Systems) (Werum Pas-x) pharmaceutical process systems executing design, commissioning, troubleshooting activities is required
- Working knowledge of cGMP type systems and practices is required
- Strong foundation of Industrial Automation and Manufacturing IT Systems
- Computer System Validation (CSV) Experience 5+
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