*Title: QA Specialist* *Location: West Point, PA* *Interview: Telephonic* *Experience:5 - 8 Years* *Pharma Experience is Must*
*OPT is also Fine* *Job Description:* · Minimum of 8 years of QA experience or hands on IT CSV experience in a Pharmaceutical environment or equivalent. · Resource will be required to provide QA reviews on all SDLC deliverables for IT (SAP, Veeva, track wise, etc..), Manufacturing (MES, SCADA, etc..), and/or Lab Informatics (LIMS, Empower, NuGenesis) systems undergoing computer systems validation (CSV). · Solid understand of GAMP5 principles and SDLC deliverables. · Working knowledge of 21 CFR Parts 210 & 211 (GMPs) and 21 CFR Part 11 (E-rec/E-sig). · Experience with Quality Risk Management (performing risk assessments and using results for determination of test strategies). · Ability to work onsite out of West Point, PA. My guess is there will be flexibility to work remote a few days per week. Thanks & Regards, Ram M Karwell Technologies Inc., 285 Durham Ave, Suite 11, South Plainfield, NJ 07080 Phone: (908) 428-5283 || Email: [email protected] Hangouts: [email protected] -- You received this message because you are subscribed to the Google Groups "Visa Transfer OPT, CPT, PT, H1,H4" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/paul_talluri. For more options, visit https://groups.google.com/d/optout.
