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Sarla Advantech
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Validation Engineer

Validation Engineer

Sarla Advantech

2 - 6 years

|

6 - 7 Lacs

ahmedabad bengaluru mumbai (all areas)

Posted:21 hours ago| Platform:

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Skills Required

validation 21 cfr part 11 oq csv iq gamp cfr

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Must be aware of regulatory guideline like 21 CFR part 11, EUannex 11, GAMP 5 etc..
Must know about GAP assessment
Must have exp in handling CSV of L1 , L2 system like DAS, DCS, Empower ,OSD /injectable Mfg equipment
Must have knowledge for performing category 4 and 5 system
Preparation and execution of validation deliverables like IRA,VP, URS,FS, CS, DS, FRA, IQ, OQ, TM, VSR
Execution of qualification document without DI

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Sarla Advantech

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