Validation Lead
3 weeks ago
Job: Validation Lead (CSV, Clinical Systems)
Location:NJ/PA(Hybrid)
Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience
Roles and Responsibilities:
We are looking for a pure validation resource
- 8 + years Experience in Validating GxP applications
- Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy
- Review and final Approval of requirements, Technical Design and Solution Architecture Plan, IQ, OQ and PQ pre and post execution documents.
- Perform all aspects of QMS (Quality Management System) processes (Change Control, Deviation, CAPA) as well as Validation Maintenance of computerized systems.
- Ensure appropriate regulatory requirements are addressed in the validation protocols.
- Execute validation/test protocols, follow good documentation practices, support discrepancy/deviations investigations and corrective action identification
- Author Reports and Trace Matrices for the computer/computerized systems.
- Perform gap assessments on vendor executed protocols, ensuring compliance is met and maintained.
- Support risk assessments and impact assessments following applicable SOPs.
- Provide guidance/support during specification (URS, FS, DDS or CS) document generation and review..
- Excellent written and oral communication to include accurate and legible documentation skills.
- Ability to work in a fast-paced environment. Team oriented. Independent work skills and a strong work ethic.
- Microsoft Office and database management skills.
- At least 8+ years of relevant computer systems validation systems/software/equipment supporting GMP manufacturing operation and laboratory equipment/instruments in a Pharmaceutical or CDMO industry.
- Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical industry a plus.
- Bachelor's degree in Engineering/Pharma/Lifescience, Computer Science in related discipline or equivalent.
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