| Validation Manager in USA (Remote) at Remote, Remote, USA |
| Email: [email protected] |
| From: Kundan Mishra, ATS INC [email protected] Reply to: [email protected] Position: Life Sciences Compliance & Validation Manager Location: USA (Remote) Job Description: ERP Validation experience is a must. Cloud ERP validation experience with platforms like SAP, NetSuite, Oracle Fusion. Architect for driving Computer System Validation (CSV) related activities and deliverables Ability to perform Validation Risk assessment and create Validation master plan Establish Test Protocols for IQ/OQ/PQ.. Creation of Approval matrix for all Validation Deliverables. Coordinate formal Validation test scripts working with the Offshore Testing team. Coordinate formal validation test execution with Business and overseeing Defect management and resolution Establish Robust Change control process for ongoing Validation Qualifications: Must have Bachelors degree , masters degree preferred. Highly articulate , well spoken and excellent Consulting and presentation skills. Expert level skills with Computer Systems Validation (CSV) / 21 CFR part 11 / part 820 / EU Annex 11. Keeps himself updated on changing industry Regulations Worked with Pharma and Med Devices companies for 10+ years Has a good understanding of Pharma / Biotech / Med devices Supply Chain, Manufacturing & QA processes. Has worked with Global Life Sciences companies in leading Validation efforts for US and international locations. Collaborated with Business QA leaders and advised them of Best practices related to compliance & Validation. Thanks & Regards Kundan Mishra Sr. Technical Recruiter [email protected] Keywords: quality analyst Validation Manager in USA (Remote) [email protected] |
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| Wed Oct 30 02:01:00 UTC 2024 |