| Lead Validation engineer(CSV Lead) :: Raritan, NJ (Contract position) :: (Onsite) at Raritan, New Jersey, USA |
| Email: [email protected] |
| Only local to New Jersey or nearby candidates Please mention work authorization and current location while sharing the resume Hi, Hope you are doing well !! This is Raghwendra, and Im a Sr. Technical recruiter with E-Solutions., a diversity-inclusive global workforce solutions company headquartered in San Jose, California. I was going through your resume and wanted to share this amazing, fast-moving opportunity that I have, which seems like the perfect fit for a dynamic person like you. Heres the job description for your reference. Job Title : Lead Validation engineer(CSV Lead) Job Location: Raritan, NJ (Onsite) Job Duration : Long term contract position Job Description :- Minimum 10 years regulated industry experience preferred with Computer System Validation or Quality management or Business Analysis in GxP application area. Application of FDA guidance s and industry standards (i.e., GAMP) . Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teamsPossesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules and documents them for software development. Resource has to be Knowledgeable and extensive experience performing computer systems validation (CSV) remediation type activities (i.e., GxP identification, Gap Analysis, Executing Test Scripts, Documenting Rationale, Preparing Plans/Report, Presenting Status Updates to stakeholders, etc.). Working knowledge of ISO and CFR (211, 820, Part 11) requirements, Possesses strong communication skills to interact with business stake holdersShould be able to handle and guide multiple GxP projects. Ability to work with project team to facilitate interaction between Project team and Business Stake holders. Ability to manage and provide guidance / train the team on Policies, end to end SDLC Process, Procedure and ToolsTrains the project team on the relevant procedures associated with different SDLC processes and Tools Strong in Project Management tools like JIRAManage Project priorities based upon identified risks.Must be able to work independently and Lead Project Teams, Excellent English verbal and written skills required. Previous CSV, regulatory remediation or due diligence experience is a must. I'm interested in getting to know you better and introducing our company. Please let me know your availability today or this week for a quick call. Wishing you a wonderful day ahead! Sincerely, Raghwendra Singh Sr. Technical recruiter w: www.e-solutionsinc.com e: [email protected] Disclaimer: E-Solutions Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability. -- Keywords: information technology New Jersey Lead Validation engineer(CSV Lead) :: Raritan, NJ (Contract position) :: (Onsite) [email protected] |
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| Wed Aug 21 00:33:00 UTC 2024 |