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Hi
Hope doing well
Please do let me know if you available for below position
Position
Job Description – SQA Validation Engineer
Location: South San Francisco, CA
Duration: 6 months+
Start Date: Immediate
Job Description
Seeking an SQA consultant with 5 + years of experience.
Responsibilities:
• Generate/review validation deliverables for multiple ongoing projects running in parallel.
• Provide input on testing, validation and documentation to project managers and IT project teams.
• Provide input for testing protocols (IQ/OQ/PQ) to support IT systems used in clinical trials and non-clinical studies.
• Provide validation and change control support and guidance per current SOPs, and help in formulating the validation strategy for GLP/GCP computer systems in gRED IT.
• Collaborate with other Systems Specialists, and assist in resolving technical and project-related issues.
• Ensure applicable regulations, guidelines and internal procedures related to validation of GLP/GCP computer systems are followed and applied during all stages of the defined software development life cycle (SDLC).
• Apply industry guidance and best practices regarding the validation and documentation of computer systems (e.g., GAMP).
SQA Minimum Qualifications:
• Bachelor's degree in Computer Science or a related discipline.
• 5+ years of experience in SQA.
• 5+ years of validation experience in a GxP environment in the biotech or pharmaceutical industry.
• Formal training and proficiency in systems development methodologies and computer systems validation in regulated industries (GAMP, Part 11, FDA guidelines and regulations).
• A good understanding of GLP and GCP regulations; experience in the validation of computer systems used in clinical trials and/or non-clinical studies (e.g., LIMS, Clinical Data Management).
• Expertise in interpretation of the applicable regulations that impact computer systems (e.g., 21 CFR Parts 11, 50, 58, 312) used in GxP environments; expertise in related FDA guidelines, regulations, as well as ICH GCP guidelines.
• Knowledge and experience with system/database design and architecture, change control, as well as Quality Assurance (QA) methodologies.
• Must be able to manage multiple tasks, work independently, and have strong oral and written communication skills. Customer focus and being a team player are a must.
Details required:
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Regards
Shiva
Sr.IT Recruiter
3086 Route 27, Suite 1, Kendall Park, NJ 08824
Phone: 732 348 5000 X 307
Direct: 732 658 4152
Fax: 425 732 8072
Email: shiva@precisiontechcorp.com
www.precisiontechcorp.com - A New Jersey MBE/WBE Certified Company
Y !D/Gtalk ID: shivarecruiter9
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