What are the responsibilities and job description for the CSV/CQV Consultant position at ANSA Compliance?
CSV/CQV Consultant
Position Summary:
We are looking for a highly motivated and detail-oriented CSV/CQV Engineer to support commissioning, qualification, and computer system validation activities in regulated pharmaceutical and biotechnology environments. This is a very dynamic and fast-paced environment, and the individual is expected to multi-task, communicate effectively, and possess a strong work ethic. Compensation will be hourly based.
Responsibilities
- Support Computer System Validation (CSV) and Commissioning, Qualification, and Validation (CQV) activities for equipment, instruments, and related systems
- Draft, review, and support execution of validation lifecycle documents, including System Impact Assessments, GxP Assessments, System Risk Assessments, User Requirement Specifications, IQ/OQ/PQ protocols, Trace matrices, Summary reports
- Translate system requirements into executable validation protocols and test scripts
- Provide support for qualification and remediation efforts, including data integrity and gap assessment activities
- Assist with vendor qualification documentation and ensure required approvals are in place prior to execution
- Track validation deliverables, provide project status updates, and support timeline management
- Work cross-functionally with stakeholders, system owners, vendors, quality, and project teams to drive deliverables to completion
- Support compliance with applicable regulatory and quality requirements, including GMP/GLP and 21 CFR Part 11
- Participate in client meetings and contribute to overall project execution and readiness
Requirements
- Experience in CSV, CQV, equipment qualification, or validation support in a regulated industry
- Working knowledge of: GAMP 5, 21 CFR Part 11, Data Integrity, GMP and/or GLP environments
- Strong technical writing and documentation skills
- Must possess working knowledge of GMP regulations and other policies/regulations as applicable.
- Must have the ability to function in a fast-paced environment and communicate effectively with management.
- The candidate must be dependable, reliable, and professional.
- Must demonstrate honesty and integrity.
- Must have working knowledge of Microsoft Office Applications.
- Must have strong understanding of good manufacturing practices and/or good laboratory practices.
- Must comply with the company code of conduct, policies and regulatory standards.
In order to be considered, please answer the following questions listed below:
- How many years of CSV experience do you have?
- How many years of CQV experience do you have?
- How many years of gmp/glp experience do you have?
Resumes will not be considered for those who fail to answer the above questions.
Company
ANSA Compliance is a compliance service, project management, and staffing provider that specializes in serving the pharmaceutical, biotechnology, and medical device industries. With over 20 years of combined experience in the compliance sector, the ANSA team can support clients throughout any stage in the development lifecycle.
ANSA Compliance pledges to create and maintain a workplace where all employees have the chance to participate and contribute to the success of the business. Employees at ANSA Compliance are valued and appreciated for the skills, experience, and unique perspective that they bring.
Job Type: Contract
Pay: $50.00 - $75.00 per hour
Application Question(s):
- To be considered, please answer the following questions:
How many years of CSV experience do you have?
How many years of CQV experience do you have?
How many years of gmp/glp experience do you have?
Resumes will not be considered for those who fail to answer the above questions.
Experience:
- CQV: 2 years (Required)
- Laboratory: 2 years (Required)
- pharmaceutical: 2 years (Required)
- CSV: 3 years (Required)
Work Location: In person
Salary : $50 - $75