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Senior Executive / Junior Manager - QMS Engineer

4.00 to 8.00 Years   Delhi   04 Jul, 2022
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaService / Installation / Repair
EmploymentTypeFull-time

Job Description

    Investigation Report writing (methods of Root cause analysis: brainstorming, WHY WHY analysis). Understanding of writing the corrective & Preventive Action, knowledge to apply SOP for the sections where reference is required for justifying the types of errors & then concluding with all the evidences. Preparation of QMS reports weekly & monthly. Timely closure of Quality Management System, Corrective Action Preventive Action, Deviations, CCFs. Training Coordinator Technical investigation report writing Reports on QMS requirements Documentation support for audits readiness. Ensuring the timely calibration of instruments related procedure, planner of Syngene facility by the Instrumentation team. Ensuring of preventive maintenance of the equipment related procedure of Syngene facility by the maintenance team. Writing Standard operating procedures (SOPs), End of procedure (EOPs), Intensive Office Procedures (IOPs) as per the units &in lines to corporate guidelines. Preparation and review of Engineering & Maintenance SOPs pertaining to Business Unit function Issuance of logbooks and review of executed logbooks for completeness. Issuance of format and protocol numbers. Physical verification of CAPAs in the facility triggering from audits/Quality Management System Handling of TrackWise for follow-up and closure of all QMS elements, whichever is applicable. Training of employees on various aspects like Good Documentation and aseptic practices. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety Attend training on environment, health, and safety (EHS) measures imparted companyEducational Qualification: BE/B.Tech Masters in Science with exposure in Quality Department of Bio-Pharma can also be considered.Technical/functional Skills: Technical report writing (English grammar) Timely checks on planners, CAPA, CCFs, Deviations, Observations. Good Understanding of Investigation report writing.Experience in handling CFT concerns for any revision in GENSOP & block specific SOPsExperience: 4-8 years of QMS experienceBehavioral Skills: Good communication skill Ability to work under pressure Problem-solving skills Teamwork skills,

Keyskills :
salesstandard operating proceduresdeliveryequal employment opportunitymiscustomer relations

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