Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11. * Creation and review of validation deliverables including but not limited ...
Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11. * Creation and review of validation deliverables including but not limited ...
Validation Specialist III
Framingham, MA · On-site
Perform 21 CFR Part 11 and EU Annex 11 gap assessment on existing scientific application software ... validation (IQ/OQ/PQ). Receive instructions on related assignments under general supervision. The ...
Validation Specialist III
Framingham, MA · On-site
Perform 21 CFR Part 11 and EU Annex 11 gap assessment on existing scientific application software ... validation (IQ/OQ/PQ). Receive instructions on related assignments under general supervision. The ...
WI · On-site
$110 - $140/hr
The ideal candidate will have extensive experience validating computerized systems within the ... Ensure compliance with FDA, cGMP, GAMP 5, ALCOA+, and 21 CFR Part 11 requirements. * Collaborate ...
Sr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible ... Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 ...
Quick apply
Sr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible ... Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 ...
Validation Engineer 1 as 100% Remote
Sunnyvale, CA · Remote
$74/hr
Validation Engineer 1 Location: 100% Remote Duration: 03 Months Pay Rate: $60.00 - $74.00/- on W2 ... Good understanding of CSV, CSA, FDA regulations (21 CFR Part 11 & 820), GAMP5 & GxP regulations.
Quick apply
Validation Engineer 1 as 100% Remote
Sunnyvale, CA · Remote
$74/hr
Validation Engineer 1 Location: 100% Remote Duration: 03 Months Pay Rate: $60.00 - $74.00/- on W2 ... Good understanding of CSV, CSA, FDA regulations (21 CFR Part 11 & 820), GAMP5 & GxP regulations.
Sr. Validation Lead
Chicago, IL · On-site
$120 - $170/hr
FDA Validation Guidance Document * 21 CFR Part 11 Electronic Records; Electronic Signature Final ... Rule * U.S. FDA Data Integrity Guidance * NIST Cybersecurity Framework * 21 CFR Part 210/211 cGMP
New
Sr. Validation Lead
Chicago, IL · On-site
$120 - $170/hr
FDA Validation Guidance Document * 21 CFR Part 11 Electronic Records; Electronic Signature Final ... Rule * U.S. FDA Data Integrity Guidance * NIST Cybersecurity Framework * 21 CFR Part 210/211 cGMP
New
Lab system validation engineer (Onsite)
Rahway, NJ · On-site
$75 - $95/hr
Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. * Experience of CSV Validation in any one of the Lab systems is must. * Should worked in ...
Lab system validation engineer (Onsite)
Rahway, NJ · On-site
$75 - $95/hr
Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. * Experience of CSV Validation in any one of the Lab systems is must. * Should worked in ...
Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11. * Creation and review of validation deliverables including but not limited ...
Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11. * Creation and review of validation deliverables including but not limited ...
PM with 21 CFR 11 (Electronic Records; Electronic Signatures) experience Location: Carlsbad, CA ... CRM, ERP, Validation applications, Financial area, etc. is desirable. Leverage industry best ...
PM with 21 CFR 11 (Electronic Records; Electronic Signatures) experience Location: Carlsbad, CA ... CRM, ERP, Validation applications, Financial area, etc. is desirable. Leverage industry best ...
CSV Consultant
Norwood, MA · On-site
$90 - $120/hr
... 5, and 21 CFR Part 11 while partnering with Bioinformatics, IT, Quality, and Laboratory teams. Key Responsibilities * Perform validation of bioinformatics software and data analysis systems.
New
CSV Consultant
Norwood, MA · On-site
$90 - $120/hr
... 5, and 21 CFR Part 11 while partnering with Bioinformatics, IT, Quality, and Laboratory teams. Key Responsibilities * Perform validation of bioinformatics software and data analysis systems.
New
Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance * Hands-on experience authoring and executing IQ/OQ/PQ protocols * Experience validating at least two of: laboratory instruments ...
Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance * Hands-on experience authoring and executing IQ/OQ/PQ protocols * Experience validating at least two of: laboratory instruments ...
PM with 21 CFR 11 (Electronic Records; Electronic Signatures) experience Location: Carlsbad, CA ... ERP, Validation applications, Financial area, etc. is desirable. • Leverage industry best ...
PM with 21 CFR 11 (Electronic Records; Electronic Signatures) experience Location: Carlsbad, CA ... ERP, Validation applications, Financial area, etc. is desirable. • Leverage industry best ...
Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance * Hands-on experience authoring and executing IQ/OQ/PQ protocols * Experience validating at least two of: laboratory instruments ...
Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance * Hands-on experience authoring and executing IQ/OQ/PQ protocols * Experience validating at least two of: laboratory instruments ...
Validation Tester
Farmingdale, NY · On-site
... 21 CFR Part 11 compliance validation and Computer Systems Validation (CSV) • Deep understanding of FDA regulations, GxP requirements, and data integrity • Experience supporting FDA approval ...
Validation Tester
Farmingdale, NY · On-site
... 21 CFR Part 11 compliance validation and Computer Systems Validation (CSV) • Deep understanding of FDA regulations, GxP requirements, and data integrity • Experience supporting FDA approval ...
Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 ... Review and QA approve various types of system validation and infrastructure qualification ...
Quick apply
Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 ... Review and QA approve various types of system validation and infrastructure qualification ...
CSV Consultant
Raritan, NJ · On-site
$45 - $50/hr
Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations. * Review and approve system testing, UAT scripts, design specifications, and validation deliverables. * Support ...
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CSV Consultant
Raritan, NJ · On-site
$45 - $50/hr
Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations. * Review and approve system testing, UAT scripts, design specifications, and validation deliverables. * Support ...
CSV Consultant
Raritan, NJ · On-site
$120 - $180/hr
Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations. * Review and approve system testing, UAT scripts, design specifications, and validation deliverables. * Support ...
CSV Consultant
Raritan, NJ · On-site
$120 - $180/hr
Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations. * Review and approve system testing, UAT scripts, design specifications, and validation deliverables. * Support ...
CSV Consultant
Raritan, NJ · On-site
Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations. * Review and approve system testing, UAT scripts, design specifications, and validation deliverables. * Support ...
CSV Consultant
Raritan, NJ · On-site
Ensure compliance with GAMP 5, CSA, 21 CFR Part 11, Annex 11, and GxP regulations. * Review and approve system testing, UAT scripts, design specifications, and validation deliverables. * Support ...
Senior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing ... Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 ...
Quick apply
Senior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing ... Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 ...
Senior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing ... Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 ...
Quick apply
Senior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing ... Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 ...
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Contractor
Re-posted 14 days ago
Job description
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Job Description:
- Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development.
- Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software.
- Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards.
- Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
- Creation and review of validation deliverables including but not limited to.
Responsibilities:
- Requirement Specifications (User, Functional).
- Plan.
- Qualification Protocol (Installation, Operational, Performance) Reports (Summary, Exception) of protocol execution.
- Traceability Matrix.
- Periodic Reviews.
- System Retirement/Decommissioning.
- Execution of Dry/Test protocol run.
- Conduct Periodic Reviews to determine if system is in a validated state and take appropriate actions.
- Perform System Retirement/Decommissioning of systems not in business .
- Work closely with software development and IT teams to establish best practices for quality and compliance.
- Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
- Drive continuous improvement initiatives in software development processes, ensuring alignment with the company's quality management system.
Requirements:
- A Minimum bachelor's degree in engineering, Science or related technical field.
- Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.
- Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304).
- Experience with non-product software validation, including tools for development, testing, and maintenance.
- Good knowledge and experience of CSV activities but not limited to.
- GxP and 21 CFR Part 11 applicability/criticality assessment.
- Identification, Preparation and Review of validation deliverables such as Requirements, Plan, Protocols, Test specifications, Reports, Traceability Matrix etc.
- Execution of Dry/Test protocols.
- Conduct Periodic Reviews of systems.
- Perform System Retirement of systems that are not in business.
- Understanding of Medical Device Quality and Compliance.
- Good knowledge of GxP, GAMP and 21CFR Part 11 guidelines.
- Working experience in Product Lifecycle Management (PLM) too.
- sound knowledge of computer system development lifecycles.
- Knowledge of JIRA, JAMA software and test automation is a plus. "
- Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304.
Additional Information
All your information will be kept confidential according to EEO guidelines.
About Katalyst Healthcares & Life Sciences
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US