Role & seniority: Validation Lead (mid-to-senior level)

Location & work type: Boston, MA 02163; 6+ month contract

Stack/tools: Validation strategy development; FDA 21 CFR Part 11 knowledge; GAMP5 V-model; risk-based validation; validation/test plans, risk management plans, test/validation summary reports

Top 3 responsibilities

Develop validation/testing strategies based on system risk and defined procedures
Author and maintain validation/testing documentation (plans, risk management, summaries)
Conduct Functional Risk Assessments and coordinate knowledge transfer (KT) activities with business analysts, developers, and clients

Must-have skills

Experience with FDA 21 CFR Part 11 regulations
Strong understanding of GAMP5 V-model and risk-based validation
Ability to design KT plans, perform reverse KT, and create training materials
Proficiency in gathering requirements and producing validation artifacts

Nice-to-haves

Client-facing experience and workshop facilitation
Experience creating customer portals or artifacts for knowledge transfer
Company framing: Net2Source Inc. is an employment solutions firm; standard contractor engagement with emphasis on regulatory validation in life sciences.

Full 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.

Role: Validation Lead

Location: Boston MA 02163

Duration: 6+ Month Contract

Job summary (a) Development of validation and testing strategies based on system risk complexity and other applicable factors as per the defined procedures (b) Authoring/development of validation & testing documentations such as Validation/ Test Plans Risk Management Plans Validation/ Test Summary Reports (c) FDA 21CFR part 11 regulations knowledge (d) Thorough understanding of GAMP5 V-model and risk-based validation process (e) Perform Functional Risk Assessment

Gather inputs from the business analyst and development team to understand technology business requirements test data requirements and application Seek review inputs on reverse KT document from the client Participate in KT session in case of new tools and technologies Participate in the client meeting to understand the requirement Design KT plan (that includes KT scope schedule and deliverables like reverse KT document) and share the same with the customer Provide training to the associates as a part of reverse KT Create portals to upload customer details

Regards, Prashant Singh Sr. Account Manager - Enterprise Business Net2Source Inc. prashant.singh@net2source.com

Direct # (201) 285-5087 | Board # (201) 340-8700 Ext. 509 | Fax: (201) 221-8131

Corp. HQ's: 317 George St., Suite 220, New Brunswick, NJ 08901

LinkedIn: https://www.linkedin.com/in/prashant-singh-b1b23526

Website: www.net2source.com

Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in—with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out—with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.

Equal Employment Opportunity Statement

Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Awards and Accolades

America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for Fastest Growing Business in the US
12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)