Job Description :
1. Minimum 9-10 years’ experience in CSV specifically on labs systems and instruments (TOC, Kaye validators, Blue Hill Instron, Microscopes etc. Experience in field of Validation in FDA regulated Environment with concentration in Computer System Validation (CSV), Laboratory Instruments and Medical Device
2. Experience in computer systems validation as per FDA regulations including 21 CFR Part 11 electronic records, electronic signatures requirements
3. Experience in the creation and execution of Validation deliverables for a System mainly; Validation Master Plan (VMP), User Requirements Specification (URS), Functional Specification, Configuration Specification, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Validation Summary Report (VSR), and Requirements Traceability Matrix (RTM
4. Experience in validating the Laboratory Instrument(s) with preparing documentation of all the key deliverables of the validation life cycleused for cGMP and 21 CFR part (11, 210, 211 & 820)
5. Extensive experience of performing the Gap Analysis and Risk Analysis for the system/products in GMP/GLP environments.
6. Exposure to ISA 95 stack & various industrial automation and manufacturing application preferably with in Pharma industry
7. Ability to follow and comply to validation SOPs.
8. Experienced in change control management and experience working with Electronic Document Management system (DMS) like Ennov, Documentum, SharePoint to archive and retrieve documents.
9. Exposure in different testing strategies including automated and manual testing strategies.
Preferred Skills
1. Experience in documentation and documentation management
2. Interviewing stakeholders & SMEs
Job Roles/Responsibilities
1. Work as validation analyst to validate a given system. Responsibly manage all the validation documentation in compliance with the client SOPs
2. Report regular progress to PM/ PMO/ Client stakeholders
3. Interact with stakeholders to gather requirements and getting reviews/ approvals