Senior Technical Lead- LABX Validation
Job ID : 27031
Job Title : Senior Technical Lead- LABX Validation
Location : Durham, NC
Comapny Name : QData
Job Type : contract
Industry : Information Technology
Salary : $55 - $60 per hour
Work Authorization : ["OPT","H4","Have H1 Visa","TN Permit Holder","Green Card Holder","Canadian Citizen","US Citizen"]
No. of Positions : 1
Posted on : 08-28-2020
Required Skills : Senior Technical Lead- LABX Validation
Benefits : None of These
Job Description :
Hi,
Hope you are doing good…!!!
We have an urgent requirement below, please go through Job description and send your updated profile and expected rate ASAP.
Please reach me at -----@----.com
Job Title: Senior Technical Lead- LABX Validation
Location: Durham, NC
Job Description:
Qualifications:
- 10+ years of Lab Systems validation experience is required.
- Mettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters; 2+ years’ experience with LabX method development and validation preferred.
- Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
- Understanding of Data Integrity concepts is required
- Excellent communication and written skills required
Responsibilities:
- Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems & LabX (Mettler)
- Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
- Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
- Coordinate alignment of systems users from various company groups on validation and qualification documentation
- Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
- Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
- Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
Thanks & Regards
Victor Smith
Sr. Recruiter
Qdata Inc
2440 Timber Ridge Dr, Unit #103, Suite A, Frisco, TX-75036
|Off: (469) 262 5643 |P : (469) 415-4203| Email: -----@----.com |
Website: www.qdatainc.com
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