Computer System Validation – CSV

Job Description / Key Responsibilities :

Experience in validating Acquisition / Divestiture / Separation program

3 years experience with System Development Lifecyle 5 years experience in Computer System Validation (Based on the role selected)

Experience in FDA and / or Global regulated environment with good understanding of GxP standards and Risk based validation.

Experience in FDA and / or Global regulated environment with good understanding of GxP standards and Risk based validation

Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements Compliance / validation Plans test protocols Test Summary reports and Compliance / Validation Reports

Experience in reviewing system test and user acceptance test scripts Traceability matrix and Design Specs. Experience in QA Methodologies designing reviewing and approving Test Plans systems and UAT test scripts and Test procedures.

Strong verbal and written communication skills.

Ability to work as a team player lead a team or accomplish tasks without supervision.

Ability to work with remote teams and support several changes / projects simultaneously.

Ability to provide Validation guidance timely reviews and escalations to TQ management.

Must be able to work 3 days on-site at Raritan NJ

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full Time

Experience : years

Vacancy : 1