Validation Jobs in South Plainfield
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Search Results - Validation Jobs in South Plainfield
Katalyst Healthcares & Life Sciences-South Plainfield
or closure of escalations. (4.) To develop and guide the team members in enhancing their technical capabilities and increasing productivity.
Additional requirement:
"Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring...
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Katalyst Healthcares & Life Sciences-South Plainfield
and guide the team members in enhancing their technical capabilities and increasing productivity.
Collaborate with cross-functional teams, including IT, quality assurance, and business stakeholders, to define validation requirements and implement risk-based...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Possess hands-on experience with the Veeva Vault QualityDocs System.
Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration...
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Katalyst Healthcares & Life Sciences-South Plainfield
Develop, validate, and implement analytical test methods for combination products in compliance with regulatory standards and internal quality requirements.
Collaborate cross-functionally with device engineers, laboratory teams, and quality...
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Katalyst Healthcares & Life Sciences-South Plainfield
Job Description
The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. The QA Validation Lead provides compliance guidance to InClin business...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Designing and executing validation including support of computer system validation protocols to ensure consistency of data production and compliance with client's quality standards (including internal ISPE referenced guidelines...
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Katalyst Healthcares & Life Sciences-South Plainfield
results and maintain records for later analysis
Documentation and remediation of deviations resulting from validations/qualifications.
Utilizes established protocols to perform validation and qualification tests and provide detailed and accurate analysis...
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Katalyst Healthcares & Life Sciences-South Plainfield
Expert in CSA validation principles.
" Automated testing experience a must
" Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process.
" Developing, reviewing, and executing testing documentation...
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Katalyst Healthcares & Life Sciences-South Plainfield
Provides basic business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments and the client to initiate and complete performance qualification (PQ) validation. Facilitates the validation...
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Katalyst Healthcares & Life Sciences-South Plainfield
with Test Method Validation and/or Measurement System Analysis is preferred.
Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
Demonstrated understanding of FDA...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
Author validation protocols ensuring that the technology solutions being...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities and Requirements:
Must be from Life science or Pharma domain experience.
He should be capable of managing 10+ members team.
7+ years of total IT experience out of which 5+ years of experience in Computer
Systems. Validation...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities and Requirements:
5+ yrs testing/validation experience with LS background.
Strong knowledge/experience with LIMS (Laboratory Information Management System), Sitara / LIMS Instrument Integration.
Good understanding of Pharma CSV...
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Katalyst Healthcares & Life Sciences-South Plainfield
Specific Job Responsibilities
Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities
Ensure the lab instruments are calibrated prior to performing IQ/OQ and certify.
Produce GxP documentations for the instrument software validation.
Own change controls and deviation management
Prepare and execute IQ/OQ protocols...
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