Padmi

Quality Assurance Validation Executive

IndiaPosted 5 months ago
Industrial And Manufacturing EngineeringSeniorFull Time, Permanent
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Job Description The QA Validation Executive is responsible for planning, execution, review, and documentation of validation and qualification activities in compliance with GMP and regulatory requirements. The role ensures that all manufacturing processes, equipment, utilities, and cleaning procedures for small volume injectables are validated and maintained in a validated state. The position plays a key role in ensuring product quality, sterility assurance, and regulatory compliance within the manufacturing facility. Key responsibilities include: Preparation, review, and execution of validation protocols and reports (IQ, OQ, PQ). Equipment qualification and process validation for injectable manufacturing. Cleaning validation to prevent cross-contamination. Validation of utilities such as HVAC, purified water, and compressed air systems. Aseptic process simulation (media fill) monitoring and documentation. Coordination with production, engineering, and QC teams for validation activities. Review of validation documents to ensure compliance with GMP and regulatory standards. Handling deviations, change controls, and CAPA related to validation activities. Maintaining validation master plan (VMP) and validation lifecycle. Ensuring audit readiness and supporting regulatory inspections. Required Skills GMP compliance Validation protocols (IQ OQ PQ) Process validation Cleaning validation Equipment qualification Aseptic validation HVAC system knowledge Water system validation Data integrity (ALCOA+) Documentation skills Deviation handling CAPA management Regulatory compliance Attention to detail Communication skills Job Information Department Quality Job Type Full-time Experience 3-5 years Location Neemrana, Rajasthan Ready to Apply Join our team and be part of our mission to provide quality healthcare solutions.

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