Validation Jobs in South Plainfield
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Search Results - Validation Jobs in South Plainfield
Katalyst Healthcares & Life Sciences-South Plainfield
We are looking for a Strong Onsite Validation Manager with VEEVA Background for GRASP Engagement,
Validation Manager : JD (Onsite)
• Strong Hands-On experience in Validation Space
• 8-10 yrs of experience
• Life Science experience is mandatory...
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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
Job Requirements:
Support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA Perform GxP and 21 CFR part 11 assessments and develop validation plan
Develop functional risk strategy and perform...
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Katalyst Healthcares & Life Sciences-South Plainfield
and time.
Demonstrate expertise in system qualification, application validation and CFR21 Part 11 compliance, and regulatory compliance governing the pharma industry.
Bachelor's degree in scientific or engineering discipline along with 4 plus years...
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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
discrepancy reports generated during validation execution and proposing CAPA's.
Requirements:
Bachelor's degree in life sciences or engineering.
5+ years of validation experience in a cell and gene therapy GMP environment.
Prior validation experience...
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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
Responsibilities:
Provide Quality oversight for the Commercial stage, including Design Transfer.
Create/revise/execute SOPs to support combination product quality governance in the commercial stage.
Evaluate design changes and provide quality...
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Katalyst Healthcares & Life Sciences-South Plainfield
Will need to understand reviewing documentation.
Looking for Risk Management – Designing FMEAs(not the process of FMEAS) – Design Verification and Validation – Test Method Validation – Design Verification and Manufacturing Tests – Part Qualification...
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Katalyst Healthcares & Life Sciences-South Plainfield
to identified user needs.
Represents IT in collaboration with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts.
Executes and facilitates GxP Computer System Validation activities...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Scope of Services: SDTM, ADaM, and TLF production and/or validation, Ad-hoc from statistics and/or other related programming requests and other statistical programming needs as requested by Company to support all clinical studies...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Develop Test/Validation Master Plan and test strategies.
Develop detailed Test/Validation scripts.
Lead testers through aggressive test cycles. This includes leading the Business Testers and interacting with Development where...
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Katalyst Healthcares & Life Sciences-South Plainfield
Systems are LIMS, SCADA, etc. Client is looking for 7-10 years of Computer Systems Validation experience. Injectable parenterals is a plus. Exerperience in Biologic, Biotech, or Pharmaceuticals is acceptable.
• Most Important Skills Needed: Computer...
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Katalyst Healthcares & Life Sciences-South Plainfield
QUALITY ANALYST: • A minimum of 4-6 years of related experience.
• Must have Process Validation experience.
• Good technical understanding of manufacturing equipment and processes.
• Knowledge of statistical software packages (e.g. Minitab...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs.
Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies and make sure efficiencies are gained at project level.
Generate and/or review of SDTM...
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