Import export documentation jobs in Diu

 ...Breakdown Analysis: Lead the troubleshooting of electrical failures using root cause analysis (RCA) and ensure that repairs are documented in compliance with cGMP standards. Statutory Compliance: Coordinate with external agencies for mandatory inspectionssuch as CEIG... 

 ...activities. Participate in investigations deviations OOS/OOT results and CAPA implementation related to validation. Maintain documentation and records in line with cGMP and data integrity requirements. Coordinate with cross-functional teams during audits and... 

 ...) and Batch Packing Records (BPR) to ensure 100% compliance with ALCOA principles. QMS Ownership: Lead the investigation and documentation of Deviations Change Controls and CAPAs .Ensure all Out of Specification (OOS) incidents in production are addressed and closed.... 

 ...in-process checks review batch records and support media fill validation sterility testing and equipment qualification . Documentation & Batch Records: Maintain BMR/BPR deviation reports and compliance documentation as per regulatory standards. Troubleshooting... 

 ...3. Visit and engage with vendors for purchase of critical machines/spares. 4. Follow up for receipt of imported machines/spares. 5. Review change control document (post-installation). 6. Provide inputs for preparation/updation of engineering drawings. 7. Develop the... 

 ...Conduct regular checks of equipment performance lubrication and utilities such as HVAC compressed air and water systems. Documentation: Fill out maintenance logs breakdown reports and equipment history records as per GMP and SOP requirements. Cleanroom Compliance... 

System Design & Optimization: Oversee the operation of Air Handling Units (AHUs) Chillers and Cooling Towers. Optimize airflow patterns and pressure cascades to prevent cross-contamination between different processing zones. Validation & Qualification: Lead the Re-qualification...