Job Description
Role - CSV/CSA Consultant
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Location - Frankford , DE (Onsite role)
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Duration - Long term Contract
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Interview - phone and Webex
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Job Description
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8+ years of experience in Pharmaceutical, Biotechnology, or regulated GMP environments.
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Lead implementation and integration of GMP Quality Control (QC) Laboratory Systems.
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Coordinate system configuration, data migration, deployment, and stakeholder engagement activities.
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Manage project execution including kick-off meetings, project planning, risk management, timelines, quality, and budget tracking.
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Support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities.
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Perform and support IQ, OQ, PQ, validation documentation, testing, and compliance activities.
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Ensure compliance with GxP, GAMP5, Data Integrity, and Roche validation standards.
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Collaborate with QA, IT, business stakeholders, laboratory teams, and third-party vendors.
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Support system integrations, release readiness, user acceptance, and production go-live activities.
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Experience with laboratory systems such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar platforms.
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Strong project coordination, Agile/Scrum, stakeholder management, and documentation skills.
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Experience with laboratory systems such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar platforms.
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Email- Anchal.singh@tekgence.com