About a minute. You'll make an account on the way through.
About this role
Responsible for review of user requirement specification, design qualification, FAT protocols, SAT protocols, installation qualification, operational qualification, performance qualification protocols and reports
Responsible for preparation of commissioning protocols, FAT, SAT and associated risk and gap analysis documents
Responsible for preparation of facility, equipment, area qualification protocols and reports
Accountable for facility, utilities, equipment and area qualification activities
Responsible for validation activities of autoclaves, manufacturing vessels, centrifuge, filterpress, vial washing, depyrogenation tunnel, filling sealing machines, HVAC system etc,
Responsible for validation activities of autoclaves, manufacturing vessels, centrifuge, filter press, vial washing machine, depyrogenation tunnel, filling and sealing machines, HVAC systems etc
Accountable for ensuring the compliance the qualification activities in-line with quality/regulatory requirements
Responsible for Engineering compliance and review of Engineering department SOPs, PM, calibration and facility maintenance schedules
Responsible for review of facility and equipment drawings
Responsible for monitoring and review of computerized system validation
Responsible for monitoring and review of risk assessment, incidents and change controls related to Qualification and Engineering and other cross functional departments
Perform or coordinate process and cleaning validations
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Facility MaintenanceVesselsgap analysisHVAC systemsSealingVial WashingRisk AssessmentSystem ValidationCentrifugeEngineering complianceFilter PressManufacturingmaintenanceHVACcompliance
About Hetero
Hetero
Pharma
3.2k+
employees
1993
33 years old
Hyderabad/Secunderabad, Telangana
India
About
One of the world’s leading producers of key Active Pharmaceutical Ingredients and generic formulations with a presence in 140+ countries and backed by 30 years of experience in the pharma sectors.
Industries
PharmaHealthcare / PharmaClinical ResearchHealthcare
Employee ratings
4,524 reviews
3.9/ 5
Culture
3.6
Career growth
3.3
Work-life
3.8
Employees rate it well for
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