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GxP Compliance Validation Specialist
2 months ago
We are seeking a GxP Compliance Validation Specialist to provide essential support to our Quality Control Analytical department. This role is pivotal in ensuring the CGMP status of our QC Instrumentation hardware and software while conducting comparability studies for the integration of analytical assays on new instruments.
Key Responsibilities:
- Support the QC Analytical department in maintaining compliance with CGMP standards for both portable and computer-controlled QC Instruments.
- Develop and author Corrective & Preventive Action plans (CAPAs) for systems requiring long-term remediation, as well as final reports for systems with short-term or completed remediation.
- Revise Standard Operating Procedures (SOPs) as part of the supporting remediation work.
- Execute change controls and validation test plans/protocols as necessary according to remediation strategies.
- Oversee the creation and execution of critical deliverables, including Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, Configuration Specifications, Requirement Trace Matrices, IQ/OQ/UAT/PQ Protocols, and Summary Reports.
Desired Skills and Experience:
- Proficient in authoring, maintaining, revising, and approving Validation Plans.
- Lead efforts to resolve deviations identified during protocol execution.
- Manage and approve vendor documentation as required.
- Possess the ability to influence and impact stakeholders in matters related to Validation and GxP compliance.
- Thrive in a fast-paced, dynamic small company environment.
- Mentor junior team members effectively.
- Experience in additional validation areas, including CSV qualification and Facility Equipment and Utility, is advantageous.
Required Qualifications:
- Demonstrated validation experience within a biotech or pharmaceutical setting, with a focus on Instrument or Computer System Validation.
- A Bachelor's Degree in Engineering, Life Science, or Computer Science is mandatory.
- Strong knowledge of process automation, computer system validation concepts, GAMP methodologies, and CFR Part 11 Electronic Records and Signatures requirements, along with current industry standards for data integrity.
White Collar Technologies is a specialized human capital consultancy firm dedicated to providing information technology and engineering consulting services within the life sciences sector. Our consultants work with a diverse range of clients across Pharmaceutical, Biotech, Medical Device, Clinical Research, and Healthcare industries. We are committed to offering our employees comprehensive Medical, Dental, and Vision healthcare benefits.
