Job Description

Position: QC Engineer Department: Quality Control Designation: Sr. Officer / Executive Total Years of experience: 4+ Years Education Qualification: BE in Electrical & Electronics Job Role: QC Instrument Engineer Responsibilities:

• Preventive maintenance of all QC / IPQA (CQC/EB Lab/Block F/IPQA Block A,B,C,P/Sampling area A,B,C/PM Labs) of manufacturing.
• Handling of all QC/IPQA Labs (CQC/EB Lab/Block F/IPQA Block A,B,C,P/Sampling area A,B,C/PM Labs) of manufacturing.
• Performing lamp energy of all HPLC instrument.
• Manage AMC/CMC contract with external vendor
• Responsibility to maintaining instrument lsit/PM calendar /Quarantine list.
• Support for review the document related to instrumentation (PPV, SPR and PTS, Qualification, Investigation, software validation / Software administration.
• CQMS related activity for preventive maintenance and breakdown of instruments.
• Manage spare inventory/PM kits for QC lab instruments.
• Coordinate with procurement team (site person, account, purchase and vendor) for timely procurement of spare parts.
• Follow ups for indent/PR/PO /Road permit/Shipment /GRN/RGP and NRGP or service clearance.
• Activity based training provided to external vendor engineer, before start internal activity. Internal activity.
• Handling /Implementation of corrective action and preventive action (CAPA).
• Support provided for installation/qualification /calibration/shifting and retirement of QC instruments.
• Coordinate with external vendor for preventive maintenance and breakdown and instruments related support activity like phase out/ upgradation activity.
• Coordinate with internal plant engineering team for utility related activity.
• Support provided for SOP preparation /Revision to internal team.
• Extended support provided to micro lab for instruments.
• Provided activity based training to QC user for optimum uses of all instruments.
• Ensure compliance to cGxP requirements and safety standard in the laboratory procedure.
• Ensure data integrity, accuracy, and adequacy of the documentation.
• Document data accurately and maintain neat/concise /organized records.

Sun Pharmaceutical Industries