1 US - Computer System Validation Consultant Job in Raleigh, NC

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US - Computer System Validation Consultant

Resolute Workforce Solutions

Raleigh, NC | Full Time

$84k-96k (estimate)

4 Weeks Ago

US - Computer System Validation Consultant

$84k-96k (estimate)

Full Time 4 Weeks Ago

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Resolute Workforce Solutions is Hiring an US - Computer System Validation Consultant Near Raleigh, NC

Client: Brevitas Corp.

Our Global Company, Brevitas Corp., is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement and effective management of change. We serve businesses in a wide range of industries including Pharmaceuticals, Food & Beverage, Chemicals, and Information Technology.

We are looking for a highly motivated and energetic individual to join our team as aComputer System Validation Consultant in Raleigh - Durham, NC.

This job is in the United States, and only candidates eligible to work in the U.S. for any employer will be considered.

By applying to this job, your profile will be considered for upcoming roles within the next 1-6 monthswhen opportunities do arise.

Responsibilities:

Develop and execute documentation for validation and qualification activities to support various computer system validation projects. List of deliverables are:

User Requirements
Functional Requirements
Validation Plan
Requirements Trace Matrix
Risk Assessment, IQ/OQ/PQ
Validation Summary Report
Data Transfer and
Integrity Testing Protocol, Change control, SOPs, etc.

Work with the project lead, team members, and quality team to address deficiencies, deviations, and change control identified during execution
Attend all relevant project meetings, develop minutes and agendas; follow up on actions with project team members
Ensure that all validation activities are coordinated appropriately with other departments to meet project timelines
Stay updated on the various guidance associated with data integrity and computer system validation

Qualifications:

Minimum a bachelor's degree in Science, Engineering, Computer Science or other technical discipline
4 years of experience in quality assurance and compliance in the pharmaceutical or biopharmaceutical industry with a focus in Computer Systems, Computerized Systems and Automated Systems
Excellent working knowledge in GAMP standards for computerized systems and automated systems and regulatory requirements in data integrity and 21 CFR Part 11
In-depth understanding and working knowledge of regulatory requirements (FDA, HPFBI, EU) in validation and qualification standards for pharmaceutical or biopharmaceutical drug product manufacturing for the international markets
Experienced in attending and responding to regulatory audits will be an asset

To Apply:

Click the “I’m interested” button below, or
E-mail your resume in MSWord or pdf format tocareers@brevitascorp.comwith the following details in the e-mail'sSubject Line:US- Computer System Validation Consultant: FIRST NAME, LAST NAME.

We thank all applicants in advance; however, we will only contact the candidates whose qualifications matchclosely tothe job requirements.We welcome and encourage applications from people with disabilities.Accommodations areavailable on request for candidates taking part in all aspects of the selection process.

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