Description
MES Validation engineer (MES Werum, FDA, GAMP5, CSV)
Requisition Details:
Mandatory Skill (List out all Technical Skills required along with domain skill required):
Computer System Validation, Life cycle, Process Validation, Risk Assessment, FDA standards, Test Planning, Corrective Action Plan
Experience in CSV for MES -Werum implementation
CSV/21CFRPart11/GxP/
Non Mandatory Skill
Project Management skills and Team handling would be preferred
Non-Technical Requirements
- Communication Skill
- Location Preference
- In-Tangible skill requirement
*Required Experience (Same as Relevant Experience)
- 8+ years of experience in CSV Implementation with atleast few MES validation experience and 1 project experience validating Werum MES application
- Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
- Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan
- Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
- Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
- Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
- Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel
- Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems
- Responsible for review & verification of Corrective Action Plan for audits
- Perform periodic review/monitoring of computer systems implemented
- Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process
- Experience executing CSV MES application namely the Werum MES application