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2 Cgmp Documentation Jobs

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2.0 - 6.0 years

0 Lacs

hosur, tamil nadu

On-site

You should have a strong knowledge of QMS /cGMP Documentation related to engineering. Additionally, you must be familiar with calibration of instruments related to Temperature, pressure, Level, flow, and weight. Basic knowledge on PLC, SCADA, and its operation is required for this role. It is important to understand breakdown and prepare breakdown analysis data. You should also be knowledgeable about P&ID diagrams and hook up diagrams, as well as all types of on-off valves and control valves. Handling of projects, contractors for Addition and Alteration of Equipments/Building facilities, and high voltage substation, Generators & Instrument control system is part of the responsibilities. You will also be responsible for complying with statutory requirements for Electrical/Mechanical Equipments. The ideal candidate will have 2 to 5 years of relevant experience and hold a qualification of BE Instrumentation / Diploma in Instrumentation. Skills required for this role include SCADA, control valves, QMS, statutory requirements compliance, change control, instrumentation, P&ID diagrams, documentation, hook up diagrams, instrument control system, calibration of instruments, on-off valves, calibration, generators, cGMP documentation, high voltage substations, PLC, and project management.,

Posted 2 weeks ago

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10.0 - 15.0 years

11 - 16 Lacs

Hyderabad

Work from Office

Role & responsibilities Job Responsibilities/Descriptions Primary Responsibilities: 1. To ensure shop floor compliance of Visual Inspection, Packaging, warehouse and Dispatch operations as per cGMP and cGWP requirements (IPQA activities). To prepare and review SOPs, study protocols, SPRs, TPRs pertaining to Fill finish, warehouse and quality assurance as required. 3. To Support in visual inspection qualification kits and visual inspection operator qualifications. 4. To review the trends of visual inspection results. 5. To support the Validation Team during the qualification activities at the area. 6. To provide Line Clearance for Visual Inspection, Packaging, Dispensing and Dispatch operations, verification of In-Process checks as defined in the batch records / SOPs. 7. To perform AQL Visual Inspection of filled units as per SOP / instructions. 8. To perform Pre-Dispatch Inspection (PDI checks). 9. To verify and ensure routine compliance of Visual Inspection and Packaging activities as per the batch records/SOPs and verification of the online documentation against each process stage, including logbooks 10. To Suppott Artwork development and management. 11. To Support in Transport Validation of Finished Products. 12. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to Visual Inspection and Packaging areas, support investigations. 13. To co-ordinate with all cross functional departments for operations related to Quality Assurance. 14. To ensure the readiness of shop floor for audits by Regulatory Authorities / customers. 15. To support market compliant investigations. 16. Ensure to perform daily random checks on material reconciliation at warehouse and report the discrepancy. 17. Ensure the warehouse documents verification and its compliance. 18. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to warehouse and Dispatch areas; support investigations. Secondary Responsibilities: 19. Follow the safety precautions at packing and warehouse areas. 20. Support the internal audits. 21. Any other responsibilities assigned by supervisor / head of the department.

Posted 2 months ago

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