16 Oct
Quality Assurance Validation II
Massachusetts, Lexington , 14625 Lexington USA

Vacancy expired!

Hello We have a new requirement with one of our client for Quality Assurance Validation IISharing the Job Description with youTitle : Quality Assurance Validation II Duration : 3+ months(Extendable)Location: : Lexington, MAExp :6 yrs

Experience

5 years’ experience in quality and compliance for

site Utilities, Equipment and Automation in a sterile environment.• Must have strong knowledge of

21 CFR, ICH Q9, ICH Q10, ISO-14644, GAMP5, ASTM-E2500 and EU regulations• Must be able to understand operational documents for

GMP compliance, accuracy and completeness• Experience with qualification for the following systems:

WFI, Clean steam, process gases, HVAC Bioreactors, Autoclaves, Chromatography skids, Tangential flow filtration (TFF)etc.• Experience with the qualification of single use technology is desired.• Experience with the qualification of a

drug product fill line (including isolator, filler) and Aseptic Process Simulation (APS) is desireRegards

Vinay KM

(: Email:

Scottsdale, AZ 85260

encora.com/

Vacancy expired!

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