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21 CFR 11 Consultant, Remote
Our client is seeking a 21 CFR 11 Consultant for a Direct Hire opportunity.
Responsibilities / Requirements
Subject Matter Expert in Computer Systems Validation
- 5+ years of experience in the pharmaceutical industry in Computer Systems Validation
- Demonstrated ability to independently provide computer system validation leadership in support of IT projects
- Utilizes depth of industry experience to provide guidance to Project Managers on compliance and technical strategy related to validation efforts, to achieve compliance with company policies and government regulations.
- Experience in computer systems validation in Research and Development, Clinical Operations, Laboratory, Manufacturing, and Marketing applications
- Ability to recommend validation methodology to complex systems based on past experiences and current industry standards utilizing GAMP 5 methodology
- Collaborate with the IT Project Managers to define the quality plans, processes, validation planning, and reporting processes
- Review and approve validation documentation including, risk assessments, specifications, protocols, and reports, with a focus on GxP impact, validation lifecycle requirements, quality, security, and compliance requirements
- Ensure that the project teams understand the Validation Plan and processes
- Participate in the review and approval of changes, risks and incidents throughout projects
- Collaborate closely with the customers, ensuring understanding of the areas of potential GxP impact that the system may have based on the business process and intended use
- Ensure that relevant business procedures are being adopted and utilized in projects following the established project methodology and utilizing the appropriate templates
- Write validation documents as required
- Balance alternative, compliant solutions based upon changing requirements and vendor deliverables
- Advise Project Managers and Customers of areas of risk/concern to projects to avoid missed milestones
- Experience working with globally disbursed teams
Experience in Quality Assurance and Compliance
- 5+ years of experience in the pharmaceutical industry in Quality Assurance
- Experience developing, maintaining and improving global compliance programs
- Thorough understanding and demonstrated experience utilizing pharmaceutical regulations, (US and European) with applicability
- Conduct risk assessments per established procedures to ensure that the project team understands the GxP applicability and regulatory risks
- Experience representing Quality and Compliance in regulatory audits
- Maintains expertise in validation/compliance and develops a greater understanding of quality systems. Uses knowledge and experience to recommend systems improvements
- Participate in supplier assessments
- Only those individuals selected for an interview will be contacted.
- No calls, inquiries, or Third Party Vendors please.
- We are an equal opportunity employer (Unable to sponsor H1B Visas).
Since 1988, The ACI Group, a Baltimore-based IT staffing firm, has been committed to hiring the industry’s leading professionals, and presenting exciting career opportunities. We have access to varied types of contract, permanent and contract-to-perm positions and offer a choice of employment options including a full benefits package.
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