Vacancy caducado!
Job Description:
- Should have worked on Life Science Computer System Validation, Risk Based Validation Approach
- Good experience in GxP Verification and Validation
- Should have experience working in validation of Serialization systems- preferably Arvato CSDB and Axway serialization systems
- Should have experience in creating Validation Master Plan, defining Validation strategy, IQ, OQ, PQ and Risk Analysis
- Should have good hands on validation testing experience including leading and defining Validation Strategy
- Should be able to independently deliver validation lifecycle deliverables for projects with minimum supervision
- Knowledge of 21 CFR Part 11 for Electronic Records and Electronic Signatures
- Good experience with SDLC and STLC
- Should have good understanding of project lifecycles and the comprehensive delivery process for GxP systems.
- Should have extensive exposure to Change Management process.
- Extensive Domain knowledge of Life Sciences/ Pharma domain.
- Excellent communication skills, leadership qualities, systematic approach and ability to work under time and resource constraints.
- Good understanding of ITIL process.
- Involved in direct client interaction.
- Competent in conflict management and escalation handling.
- Should have good experience in Computer System Validation, Risk Based Validation Approach, Alignment with GAMP 5 standards
- Good experience in writing Validation Plans, undertaking Risk Assessments, defining Validation strategies, educating teams on GxP approaches and supporting implementations, writing Validation Summaries.
- Excellent communication and stakeholder management responsibilities
- Good understanding of Change Management process (preferably using ServiceNow)
- Good experience with Validation Testing practices in GxP environments
- Experience with validating and qualifying Cloud based systems
- 21 CFR Part 11 for Electronic Records and Electronic Signatures
- SDLC and STLC, Verification and Validation for GxP systems
- Should have good understanding of project lifecycles and the comprehensive delivery process.
Vacancy caducado!