GxP Validation Engineer / Analyst (Lab Equipment)

Job Description

Job Description

Responsibilities :

• Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and computer-controlled).
• Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short-term / completed remediation
• Performing supporting remediation work in the form of SOP revisions
• Executing change controls and validation test plans / protocols when required per remediation plans
• Responsible for the development and execution of general deliverables, such as Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, Configuration Specification, Requirement Trace Matrices, IQ / OQ / UAT / PQ Protocols, and Summary Reports.

Desired Skills and Experience :

Required Qualifications :

Company Description

White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector. Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals.

We offer our workers Medical Dental and Vision healthcare benefits.

Company Description

White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector. Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals.\r\nWe offer our workers Medical Dental and Vision healthcare benefits.