Job Title: Team Lead Computer Systems Validation Consent Decree Location/City: Fort Washington, PA Title: Team Lead Computer Systems Validation Consent Decree Duration: 5 months + Rate: DOE Location: Fort Washington, PA Client: A Fortune 500 consumer health company which manufactures and markets a broad range of over-the-counter products has a need for Team Lead for Computer Systems Validation for a Consent Decree. Job Description: Work with the CSVQA team to review the required documentation for evidence binders in support of the Consent Decree Work plan Work with QSE-19 (Product Quality Complaints) team to ensure validation deliverables accurately define the business process Assist with execution of validation protocols Travel to other manufacturing sites may be required Provide mentoring/training to the project teams as needed Develop and maintain project plan of activities to be performed in support of CD activities Drive completion of activities and assist the team in issues resolution Skills Required: Education: BS in Technology related field 3 to 5 years in pharmaceutical engineering, focusing on Computer System Validation. 3 to 5 years with pharmaceutical validation experience Strong background and experience in the Computer System Validation procedures, strategy and document development Understand and background of enterprise wide systems and validation in GMP environment Technical review of computer system validation deliverables. Working with GxP systems in compliance to 21 CFR Part 210, 211, 11 (Electronic Records). Knowledge in the following regulations and guidelines: FDA Regulations (CFR Parts 210, 211, 11, 820 (Quality System Regulation)) PIC/S Guides as applicable to CGMP and Computer System Validation (Good Practices for Computerized Systems in Regulated GxP Environments) FDA Guidance on Software Validation (General Principles of Software Validation) EU-GMP Annex 11 “Computerized Systems”, regulation Must have at least 3 to 5 years experience with Pharmaceutical Engineering, specializing in Computer System Validation. Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project) Skills Summary: Computer Systems Validation Team Lead Quality review Quality complaints Validation Process Documentation Please send resumes to bhaggerty@chenoainc.com