Full Description

Title: Validation Manager / Validation Lead

Job Description

• Need candidates with any one of the application skills which we mentioned below.
• Application Skills
• Oracle Agile PLM
• Serialization
• Regulatory Applications
• Oracle EBS
• Veeva or Salesforce or other SaaS Applications
• Argus
• Mandatory Domain Knowledge
• 9 - 12 years of Experience in Life Sciences, Computer System Validation
• Must possess hands on experience and understanding of
• GAMP 5 Risk Based Validation
• Functional Risk Assessment
• GXP Assessment
• 21 CFR Part 11 Assessment
• Data Migration Qualification
• Disaster Recovery Qualification
• Qualification and Commission
• Validation coverage in IQ, OQ and PQ
• Deviation management process
• CAPA
• Validation Summary Reports
• Knowledge on Infrastructure IQ & qualification
• Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
• Must possess formal training/certification on Testing & Validation
• Excellent communication skills
• Excellent technical writing skills
• Should be able to work independently with minimum supervision
• ü Should have worked in cross-functional environments and comfortable to liaison with business