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AM / Deputy Manager Engineering ( Validation & Qualification)

8.00 to 13.00 Years   Indore   24 Sep, 2020
Job LocationIndore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Roles and ResponsibilitiesDocumentation,Validation of equipments /Systems,Quality Management system,Engineering compliance,Projects scheduling and ensuring completion of projects within timeline/SAP related activitiesSystem up-gradation & Computer system validation (CSV)-PLC/SCADA/Vision system /Process equipment/HVAC/Compressed air, Equipments qualificationReview Qualification life cycle deliverables & CSV deliverables like Validation Project Plan, URS, VP, DS, FS, TM, IQ, OQ, PQ, UAT, Computer System Risk Assessment, Periodic Review Report, Decommission Report, SOP etc.to ensure they meet GxP and FDA regulationsQualification documents like IQ, OQ, PQ for Process equipment and Automation SystemHands on experience on computer system validationsDesired Candidate Profile

  • Must be working in a Pharma formulation company is must have hands on experience in handling Validation & qualification of Process Machinery (OSD) , CSV and HVAC
  • Must Have faced regulatory audits like USFDA
Perks and Benefits,

Keyskills :
coredetail engineeringengineering designcomputer system validationquality management system

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