Senior Technical Lead- LABX Validation

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 [email protected]

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: [email protected] |

Website: www.qdatainc.com