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Validation Consultant
1 week ago
Oxford Global Resources New York, United StatesSummary: · Prepare and execute cleaning, process and packaging validation, and equipment qualification plans and protocols. Write Final summary Reports that summarize executed qualifications/validations. Assist in the development, coordination and execution of qualifications/val ...
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RSM US LLP New York, NY, United StatesWe are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture ...
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RSM US LLP San Francisco, United States PermanentWe are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture ...
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Quality Validation Consultant
2 weeks ago
Zenith LifeScience Nutley, United StatesThe Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of company's vendors and computerized systems. · Essential Functions · • Participate in computer system and vendor au ...
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IT Quality Validation Consultant
2 weeks ago
Vaco Nutley, United StatesRole:IT Quality Validation Consultant · Duration: 12 Month · Location:Nutley New Jersey (Hybrid) · Essential Functions · * Participate in computer system and vendor audits for review of their Quality Management System, SDLC, including validation, and data integrity controls. ...
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IT Quality Validation Consultant
2 weeks ago
Innova Solutions Nutley, United StatesInnova Solutions is immediately hiring for an IT Quality Validation Consultant (Hybrid). · Position : Type: Full Time, Contract on W2. · Duration : 12+ Months · Location: Nutley NJ 07677 USA · As an IT Quality Validation Consultant (Hybrid), your responsibilities:: · Descrip ...
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IT Quality Validation Consultant
2 weeks ago
Artech Nutley, United StatesThe Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of 's vendors and computerized systems. · Essential Functions · • Participate in computer system and vendor audits fo ...
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Quality Validation Consultant
6 days ago
Zenith LifeScience LLC Nutley, United StatesThe Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of company's vendors and computerized systems. · Essential Functions · • Participate in computer system and vendor a ...
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IT Quality Validation Consultant
1 week ago
Maxis Clinical Sciences Nutley, United StatesJob Description · Job Description · The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of client's vendors and computerized systems. · Essential Functions · • Partic ...
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IT Quality Validation Consultant
2 weeks ago
Vaco Nutley, United StatesJob Description · Job DescriptionRole: IT Quality Validation Consultant · Duration: 12 Month · Location: Nutley New Jersey (Hybrid) · Essential Functions · • Participate in computer system and vendor audits for review of their Quality Management System, SDLC, including validation ...
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IT Quality Validation Consultant
1 week ago
Vaco Nutley, United StatesRole:IT Quality Validation Consultant · Duration: 12 Month · Location:Nutley New Jersey (Hybrid) · Essential Functions · * Participate in computer system and vendor audits for review of their Quality Management System, SDLC, including validation, and data integrity controls. · * ...
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Director - AML Validation/Technology Consulting
3 weeks ago
RSM US LLP New York, United States Full timeWe are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture ...
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IT Quality Validation Consultant
3 weeks ago
Maxis Clinical Sciences Nutley, United StatesJob Description · Job DescriptionThe Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of client's vendors and computerized systems. · Essential Functions · • Participate ...
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IT Quality Validation Consultant
2 weeks ago
LanceSoft Woodcliff Lake, United StatesThe Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver on internal validation efforts and audits of vendors and computerized systems. · Essential Functions · •Participate in computer system and vendor audits for ...
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Software Validation Quality Consultant
2 weeks ago
Infotree Global Solutions Nutley, United StatesNo H1B and/or C2C please · Job Title: Software Validation Quality Consultant (Pharma/Biotech) · W2 Contract & Hybrid role · Nutley, NJ · One of our leading Pharmaceutical client is looking for a Software Validation Quality Consultant, who will work closely with the clinical quali ...
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Software Validation Quality Consultant
2 weeks ago
Vaco Nutley, United StatesPOSITION DETAILS: · Job Title: Software Validation Quality Consultant · Location: Hybrid in Nutley, NJ · Duration: 12-months contract on W2 · About the role: · The Software Validation Quality Consultant will work closely with the clinical quality assurance systems lead to deliver ...
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Director - AML Validation/Technology Consulting
2 weeks ago
RSM International New York City, United States Full timeWe are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. · Our exceptional people are the key to our unrivaled, inclusive cultu ...
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Software Validation Quality Consultant
6 days ago
Infotree Global Solutions Nutley, United StatesNo H1B and/or C2C please · Job Title: Software Validation Quality Consultant (Pharma/Biotech) · W2 Contract & Hybrid role · Nutley, NJ · One of our leading · Pharmaceutical client · is looking for a · Software Validation Quality Consultant, · who will work closely with the ...
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IT Quality Validation Consultant
3 weeks ago
Lenmar Consulting Nutley, United States· 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 b ...
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Software Validation Consultant
3 weeks ago
Katalyst HealthCares & Life Sciences Nutley, United StatesResponsibilities: · Participate in computer system and vendor audits for review of their Quality Management · System, SDLC, including validation, and data integrity controls. · Review CAPA and verification of CAPAs of system and vendor audits. · QA approves internal validatio ...
Validation Consultant - New York, United States - i-Pharm GxP
Description
The Validation Consultant is a key member of the project team, focusing on the validation of equipment, processes, and systems in large-scale, sterile pharmaceutical manufacturing environments.
This role involves the development, implementation, and execution of validation strategies to ensure compliance with industry standards and regulatory requirements.
Key Responsibilities:
Validation Planning and Strategy:
Develop and implement validation plans and strategies in alignment with current Good Manufacturing Practices (cGMP), FDA, EMA, and other regulatory guidelines.
Lead and execute CQV activities for manufacturing equipment, facilities, and processes, ensuring they meet predefined specifications and quality attributes.
Installation Qualification (IQ) and Operational Qualification (OQ):
Perform IQ and OQ activities, ensuring equipment and systems are installed and functioning according to manufacturers' specifications and industry standards.
Oversee PQ and PPQ to demonstrate that processes operate in a state of control and meet product quality specifications.
Protocol Authoring and Execution:
Develop, review, and execute validation protocols and reports, including but not limited to, risk assessments, test scripts, and validation summaries.
Change Control and Deviation Management:
Manage change control processes and investigate deviations from established processes or outcomes, implementing corrective actions as necessary.
Collaboration and Coordination:
Work closely with cross-functional teams, including engineering, quality assurance, manufacturing, and regulatory affairs, to ensure alignment of validation activities with project goals.
Regulatory and Quality Compliance:
Ensure all validation activities and documentation comply with regulatory requirements and quality standards, preparing for and supporting regulatory inspections and audits.
Qualifications:
Bachelor's degree in Engineering, Science, or related field.
Extensive experience in validation within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing.
Strong understanding of cGMP, FDA, EMA, and other regulatory requirements.
Proficient in the principles and practices of process validation, equipment qualification, and cleaning validation.
Excellent analytical, problem-solving, and decision-making skills.
Exceptional communication and collaboration abilities to work effectively with all levels of the organization and cross-functional teams.
Ability to manage multiple projects and priorities in a fast-paced environment.
