GXP Jobs

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GxP/SOX Validation Specialist

Advanced Software Talent

•

Newark, California, USA

Full-time

Our direct client is seeking a GxP/SOX validation specialist for the following opening: You will handle, IT GxP Systems will work to maintain a stable GxP systems environment to enhance performance, uptime, and compliance. This person will implement IT GxP policies, procedures, and best practices and serve as the organization s IT GxP Systems. This is an onsite position, with 4 days in the office and 1 day being remote. Responsibilities Build and Own IT GxP Compliance program. Partner with IT
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Posted 3 days ago | Updated 3 days ago

Requirement || GxP Validation Expert || Richmond, Virginia

Aroha Technologies

•

Virginia, USA

Contract

Position: GxP Validation Expert Location: Richmond, Virginia Must have skills : Quality leadership (Strong), SAP Activate Methodology (Capable), Testing concepts (Strong) Job Description : GxP Validation Expert for an SAP S/4HANA implementation for a Pharma company in the US. Responsibilities: Identifies the applicable laws, standards and best practices applicable to the project such as GAMP5, 21 CFR Part 11, 21 CFR Part 211, ICH Guidelines, SAP Activate methodology. Performs the GxP asse
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Posted 10 days ago | Updated 4 hours ago

SAP ATTP consultant

Altezzasys

•

Remote

Contract

Title: SAP ATTP consultant Location: Remote JOB Description: Overall Experience: 10+ years ATTP Experience: 4+ years in ATTP 1. Experience with Pharma industry Global Track and Trace Serialization system realization and deployments, including hands-on experience implementing SAP ATTP. 2. Understanding of global serialization regulations and experience installing, configuring, deploying, documenting and testing system to meet specific business requirements. 3. Knowledge of global pharma industry
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Posted 2 days ago

Business Analyst (Immediate Role)

Xoriant Corporation

•

Plainsboro Township, New Jersey, USA

Contract

Title: Business Systems Analyst II - Pharmaceutical Location: Plainsboro, NJ - hybrid role Duration: 6-12 Months Must haves: 1. Accuracy and attention to detail: GxP critical system will be in use which follows a specific process and requires analyst awareness 2. Excellent analytical skills 3. Strong investigative and documentation skills: investigating systems and using clear communications skills to report back on issues 4. Ability to handle multiple systems and related user management tasks
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Posted 3 days ago | Updated 2 days ago

Lab IT Support

RADGOV INC

•

Westborough, Massachusetts, USA

Contract

Onsite Travel to Boston once in a week Description: Lab Systems Administration & ManagementIT Infrastructure supportProcess OptimizationTroubleshooting and Issue ResolutionRegulatory Compliance (FDA, GxP)Risk Assessment and MitigationData Security and PrivacyCross-functional CollaborationTechnical DocumentationTraining and DevelopmentLaboratory Systems: LIMS Lab Vantage, Pathology Imaging (Aperio), GxP Systems, R&D systems, Nexcelom, Eclipse, Spectroflo ,Agilent, Imaging Systems, ThermoFisher, E
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Posted 10 days ago

SAP ATTP COnsultant

Altezzasys

•

Remote

Contract, Third Party

Job title: SAP ATTP COnsultant Location: Remote Contract job Description: JOB Description: Overall Experience: 10+ years ATTP Experience: 4+ years in ATTP 1. Experience with Pharma industry Global Track and Trace Serialization system realization and deployments, including hands-on experience implementing SAP ATTP. 2. Understanding of global serialization regulations and experience installing, configuring, deploying, documenting and testing system to meet specific business requirements. 3. Knowl
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Posted 2 days ago

Computer Systems Validation Consultant

Kellton

•

Hazelwood, Missouri, USA

Contract

Computer Systems Validation Consultant Hazelwood, MO 63042 12 months Pay Rate: $52/hr on W2 Job Summary: Interprets and understands relevant GxP regulations and standards and provides coaching/guidance to ensure enforcement and consistent application of GxP requirements Executes, manages and documents the periodic reviews of global GXP IT systems Review and provide coaching/oversight for non-GxP changes (MOCs) Authors and/or reviews GxP technical documents (SOPs, Work Instructions, Risk Assessme
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Posted 6 days ago | Updated 2 days ago

Business Systems Analyst

Xoriant Corporation

•

Plainsboro Township, New Jersey, USA

Contract

GxP QUALIFICATIONS: A Bachelor's degree in Computer Science, Information Systems, Business Administration or other related field required. Relevant experience may be substituted when appropriate.A minimum of 4 years of relevant experience in Computer Science, IT, programming/systems analysis or other related experience required.Ability to lead a project in the development and implementation of processes and programs.Ability to provide technical solutions to a wide range of somewhat complex probl
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Posted 3 days ago | Updated 1 day ago

CSV Engineer - Seattle/WA (Onsite)

Smart Caliber Technology

•

Seattle, Washington, USA

Third Party, Contract

Duration: 6- 12 months (extendable) Location: Seattle, WA (Onsite) Job Description: 3 to 5+ years of Computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is required. Preferred MES/ DeltaV experience. Author, review and approve GxP computer system lifecycle documentation such as URS, FRS, CS/DS, risk assessments, validation plan, test protocol, summary reports and RTM. Develop and execute test protocols and test scripts (IQ/OQ/PQ) for compute
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Posted 4 days ago | Updated moments ago

Validation Expert for S4HANA

IDI Consulting

•

Foster City, California, USA

Contract, Third Party

Support of creating and maintaining GxP (GMP, Google Cloud Platform, GLP) quality and compliance environment for SAP S/4 HANA Perform GxP and 21 CFR part 11 assessments and develop validation planDevelop functional risk strategy and perform functional risk assessmentReview user business process documents and user requirements specificationReview functional, technical and configuration design documentsPrepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qu
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Posted 8 days ago | Updated 8 days ago

IT Quality Validation / System Validation / Pharmaceutical (hybrid)

Kellton

•

Nutley, New Jersey, USA

Contract

I am working on this long term contract position for one of my major Pharmaceutical clients . They are looking for string IT Quality validation and Pharmaceutical industry experience. IT Quality Validation Consultant Prepare computer validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols, and Summary Reports. Prepare Change Control documentation. Execute test scripts. Perform risk assessments. Must be familiar with 21 CFR Part 11. Consult
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Posted 31 days ago | Updated 25 days ago

CSV Consultant

Kellton

•

Remote

Contract

Computer Systems Validation Consultant Hazelwood, MO (100% Remote)$54/hr on W212 months with possible extensionW2 Only Job Summary: Interprets and understands relevant GxP regulations and standards and provides coaching/guidance to ensure enforcement and consistent application of GxP requirements Executes, manages and documents the periodic reviews of global GXP IT systems Review and provide coaching/oversight for non-GxP changes (MOCs) Authors and/or reviews GxP technical documents (SOPs, Work
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Posted 6 days ago | Updated 2 days ago

Senior Director, Medical Safety Science

Milestone Technologies, Inc.

•

San Mateo, California, USA

Contract

Sr Director of Medical Safety (Operations) - NO C2C Location: Foster City, CA.(requires on-site time) MUST BE LOCAL CANDIDATES Contract length:6 months to start - possibility of contract to hire. Compensation: The estimated pay range for this position is USD $120/Hr - USD $135/Hr and is an Exempt role. Exact compensation and offers of employment are dependent on circumstances of each case and will be determined based on job-related knowledge, skills, experience, licenses or certifications, and l
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Posted 26 days ago | Updated 3 days ago

Equipment Validation Engineer

Pyramid Consulting, Inc.

•

Summit, New Jersey, USA

Contract

Immediate need for a talented Equipment Validation Engineer. This is a 06+ Months Contract opportunity with long-term potential and is located in Summit, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID:24-21967 Pay Range: $70 - $77/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Maintains qualified equi
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Posted 12 days ago

Project Manager

Tekniforce

•

Raleigh, North Carolina, USA

Contract

We are looking for a Project Manager. This is a six (6) months contract position in Raleigh, North Carolina with our client. In this role you would act as a primary liaison with technical and business stakeholders, manage project costs, risks, and deliverables in companys SDLC process. Responsibilities as Project Manager: Creation and maintenance of project plans, project initiation documents, weekly status reports, closing docs, and scheduling/leading regular meetings with sponsors, stakeholder
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Posted 30 days ago | Updated 23 days ago

IT PROJECT MANAGER (APPLICATIONS SIDE)

Della Infotech

•

Sunnyvale, California, USA

Contract

IT PROJECT MANAGER (APPLICATIONS SIDE)Location: Sunnyvale, CADuration: 6+ Months contractHYBRID (2 days - Tuesday & Thursday)ONLY LOCAL PROFILES CONSIDERED TOP SKILLS:- Project management (Traditional, Hybrid)- Business applications exp (SAP, salesforce, Integrations)- Medical industry experience- PMP, Agile certifications- Strong Communication- Minimum 10+ years experience (nothing less) Important notes:- Local candidate- Experience on business applications- Strong project management experience
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Posted 10 days ago | Updated 2 days ago

CSV (Pharma) Consultant

Multivision Inc-IL

•

Seattle, Washington, USA

Contract

Job Description and Qualification: 3 to 5+ years of Computer systems validation (CSV) experience in computerized equipment, QC lab and manufacturing systems is requiredAuthor, review and approve GxP computer system lifecycle documentation such as URS, FRS, CS/DS, risk assessments, validation plan, test protocol, summary reports and RTMDevelop and execute test protocols and test scripts (IQ/OQ/PQ) for computerized systemsKnowledge of regulatory requirements and standard best practices, (e.g. GLP/
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Posted 9 days ago

Sharepoint Engineer (Contract to perm)

Tech-Nique Partners

•

Queens, New York, USA

Contract

Contract to Hire / Contract to Perm Must be local to Long Island City and willing to come onsite 2-3 days per week (Tues, Wed, Thur is a flex day) Start Date: ASAP The SharePoint Engineer is responsible for the management, maintenance, and optimization of the company s controlled SharePoint environments within the organization. Installation and Configuration: Creating and configuring SharePoint sites, lists, document libraries, workflows.User Management: Managing user access, permissions, and se
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Posted 5 days ago | Updated 2 days ago

Senior IT Manager

Hallmark Global Technologies

•

Winston-Salem, North Carolina, USA

Full-time

It's a FTE role based in Winston Salem. Client will pay for relocation. Description: The Senior Manager, GMP Site Systems is responsible for the implementation and support of technology and informatics systems/tools and programs to support the development, implementation, operation, and continuous improvement of GMP Technical Operations including but not limited to manufacturing, quality assurance, quality control, supply chain, patient experience, facilities/engineering, and technical developme
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Posted 1 day ago

SAP Compliance Lead - King of Prussia, PA (Onsite/Hybrid) - Need Local

ApTask

•

King of Prussia, Pennsylvania, USA

Contract

Only W2-Contract Location: King of Prussia, PA (Onsite/Hybrid) Must have skill(s): CSV, SAP Validation, Product Serialization, DSCSA Job Description: Roles and Responsibilities SAP Compliance Lead 10years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-en
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Posted 9 days ago