Urgent Requirement of Validation Lead at Foster City, CA

Hi

 

USG direct client is looking for Validation Lead at Foster City, CA

Please share your updated resume to Yatin at yatin.k@usgrpinc.com OR feel free to contact me at 614 588 8481

 

Job Description:

Need urgent profiles here for Validation Role. Need 8+ Years of genuine Validation Resource. GMP or GxP Exp is mandatory.

 

Role: Validation Lead

Location: Foster City, CA

Duration: 12 Months

 

 

Provide compliance leadership, direction and oversight to project teams in the area of Computer System Validation.
• Responsible for the quality oversight of GxP regulated computerized systems (e.g. laboratory systems).
• Manage the release of GMP regulated systems in cloud.
• Participate in the review and approval of technical changes, Quality Incidents, CAPA's and procedures.
• Contribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systems.
• Participate in evaluating the current Crucell quality systems for GxP computerized systems, and implement improvements to comply with the current FDA/EU standards.
• Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU).
• In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits.

Qualifications
Minimum Qualifications:
• Bachelor's or Master degree in science, computer science, or relevant area
• English, fluently spoken and written
• Thorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industries
• A minimum of 10 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSV
• In-depth knowledge of computerized quality systems
• Experience with GMP inspections

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