BENGALURU · FULLTIME
CSV Project Manager
eMonkGlobal
Bengaluru · onsite · Posted 23d ago
Sourced from
Not disclosed10–12 yrsfulltimeBengaluru
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Section · 01
About this role
Role Description
- Serve as an SME in CSV processes and best practices
- Manage complex validation projects as an SME
- Provide inputs and guidance on the Validation approach. Assist in developing/modifying the validation processes and procedures
- Develop and execute validation protocols (IQ/OQ/PQ) for computer systems, software applications, and automated processes.
- Create validation plans, test scripts, and summary reports.
- Ensure all computer systems comply with FDA regulations, GxP guidelines, and other relevant industry standards (e.g., 21 CFR Part 11).
- Provide training to staff on CSV processes and regulatory requirements
- Stay updated on industry best practices, regulatory changes, and advancements in technology related to CSV.
- Identify opportunities for improving validation processes and procedures.
- 10+ years of overall experience in computer system validation within the pharmaceutical, biotech, or medical device industry.
- Experience in developing/modifying procedures for CSV
- Experience with validation of Computerized Systems (Process control systems, Laboratory systems, and Process equipment), ERP systems, LIMS, MES, or other GxP systems.
- Strong knowledge of FDA regulations, GxP guidelines, and industry standards (e.g., 21 CFR Part 11, GAMP 5).
- Proficiency in developing and executing validation protocols and related documentation.
- Proficient in using validation tools and software.
- Strong written and verbal communication skills.
- Bachelor's degree in Biotechnology, Pharmacy, Computer Science, Engineering, Life Sciences, or a related field.
- Advanced degrees or certifications in validation, quality assurance, or regulatory compliance are a plus.
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Section · 02
Skills
Validation tools and softwareGAMP5erp systemsmes21 Cfr Part 11LIMSProcess EquipmentFDA regulationsProcess control systemsGxP guidelinescomputerized systemsLaboratory Systems