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Validation Engineer
3 months ago
Job Description:
- Seeking a candidate with solid knowledge in Bio-Pharmaceutical manufacturing processes and equipment for various types of manufacturing
- Ability to perform Quality Audits and Gap Analysis to ensure compliance with international regulations
- Familiarity with regulatory guidelines such as cGMP, FDA, WHO, and others
- Responsible for preparing Validation/Verification master plans and project schedules
- Conduct Quality Risk and Impact assessments
- Provide templates for Qualification documents and execute validation protocols
- Plan, manage, and execute start-up, commissioning, and validation activities
- Participate in Factory Inspections and assist in creating validation master plans
- Identify project improvement opportunities and adhere to industry standards
- Generate and update documentation as required
- Ensure quality deliverables through effective collaboration with teams and stakeholders