Serialization Lead Boston, MA

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.