Lab System Validation at Net2Source (N2S) Lab System Validation at Net2Source (N2S) in Clark, New Jersey Posted in 2 days ago.
Type:
full-time
Job Description:
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 ion
Work Location:
Rahway, NJ
Hire 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 5087
Office:
270 Davidson Ave, Suite 704, Somerset, N J 08873: https://www.linkedin.com/in/prashant-singh-b 1b23526