Lab System Validation

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Please go through below JD and If you are interested, kindly forward your resume to Prashant.singh@net2source.com. We will review your profile and get back to you at the earliest

.

Role: Lab System Validat

ionWork Location: Rahway, NJ - ons

iteHire Type: 11 Months Contra

ct
Pay Rate: $48/hr on

W2 Pay Cycle: Wee

kly

JD:o Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GA

MP 5.o Experience of CSV Validation in any one of the Lab systems is

must.o Should worked in pharmaceutical domain and its related knowledge is

musto Good communication and technical writing skills are a

musto Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environm

ents.o Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastruc

ture.o CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is prefe

rred.o To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP

areaso Provide guidance and leadership regarding Regulatory Compliance and Quality Management require

ment.o Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix

etc.o Exposure to Regulatory Audits and Remediation activ

itieso Ensure the CSV artefacts are in line and meets regulatory require

mentso Preferred Experience in Agile Develo

pmento Knowledge on working in Jira / Servic

e Nowo Adaptation to AI is prefe

rred.• Testing (in addition to a

bove)o Experience in testing and knowledge in any one of the QC/R&D Lab systems is

must.o Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is

must.o Knowledge on working in Jira, HP ALM or any automation testing t

ools.

R

egards,Prashan

t SinghSr. Account Manager - Enterprise B

usinessNet2Sour

ce Inc.(201) 2

85 5087Office: 270 Davidson Ave, Suite 704, Somerset, N

J 08873LinkedIn: https://www.linkedin.com/in/prashant-singh-b