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System Validation Engineer
Augusta Hitech Soft Solution
posted 7d ago
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Flexible timing
Key skills for the job
Job Description
- Minimum 7 years of experience in CSV in the Pharma industry.
- Clear understanding of principle, procedures and governance of validation activities and IT controls
- Deep Knowledge of regulations: 21 CFR Part 11 / 210/ 211 and Annex 11
- knowledge to get the CSV validation compliance done based on already identified gaps.
- Understanding of quality risk-management concepts (ICH Q9)
- Experience in systems validation and quality frameworks
- Perform quality review of relevant validation documentation pre and post execution for accuracy, completeness and ensure compliance with regulatory and client requirements.
- Experience in executing change control and document management
- Strong knowledge of GAMP5 and Quality Systems
- Experience on decommission, Archiving and Data Integrity (ALOCA+)
- Experience in supporting Data Migrations from validation perspective
- Ability to communicate and work independently with Technical teams
- Adept with Agile and Waterfall methodology based software development and has prior experience in computer system validation using agile methodology.
Employment Type: Full Time, Permanent
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