MES Validation Specialist — CSV & GxP Compliance
NNIT
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Benefits offered by this job
Job summary
NNIT Philippines is seeking a Validation Consultant to ensure regulatory compliance and CSV delivery for Life Sciences IT projects. You will prepare Validation Plans, Specifications, and Qualification documents to meet customer needs and regulatory requirements, while contributing to milestones and reporting.
Responsibilities include creating validation documents, supporting risk management, validating MES systems (PAS-X, MODA-ES, Syncade, CAMSTAR), and aligning with GxP, ISPE GAMP5, and 21 CFR
Qualifications
- Experience in Life Sciences CSV and regulatory requirements (GxP, 21 CFR Part 11).
- Experience with MES validation and CSV documentation.
- Ability to create and review validation plans, IQ/OQ/PQ, deviations handling.
- Good understanding of V-model/Agile delivery and ISPE GAMP5 guidelines.
Responsibilities
- Act as Validation Consultant on Life Sciences IT projects.
- Prepare validation documents (Plans, Specifications, Qualifications).
- Support risk management, validation strategies, and testing activities.
- Review project documentation for compliance with QMS.
- Identify process improvements and contribute to CSV activities.
Skills
Tools
Job description
NNIT Philippines is seeking a Validation Consultant to ensure regulatory compliance and CSV delivery for Life Sciences IT projects. You will prepare Validation Plans, Specifications, and Qualification documents to meet customer needs and regulatory requirements, while contributing to milestones and reporting.
Responsibilities include creating validation documents, supporting risk management, validating MES systems (PAS-X, MODA-ES, Syncade, CAMSTAR), and aligning with GxP, ISPE GAMP5, and 21 CFR
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