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CSV Specialist

Maestro Technologies

This is a Contract position in Township Of Bedminster, NJ posted September 3, 2020.

Job Summary Scope would include all aspects of the Computer Systems Validation (CSV) program. Direct site execution of and adherence to global CSV policies and procedures. Execute on implementation tasks, work prioritization, and support project activities while ensuring the highest level of compliance with regulatory agencies. Track changes to the regulatory environment and implement processes and procedures enabling MNK to meet ongoing requirements such as 21 CFR Part 11, and EU Annex 11. Job Description Closely work with the Computer Systems Validation management and relevant ITbusiness counterparts to support the implementation and validation of ongoing software development projects. Develop and manage project documentation for SDLC COTS requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and perform functionality, usability and testing during required project phases. Provide oversight and review all aspects of testing associated with multiple concurrent software development andor infrastructure related projects. Utilize knowledge of all phases of Software Project Development Life Cycle and contribute to Analysis, Design, Development, Testing and Deployment of Software Applications. Ensure project deadlines and performance standards are met while communicating status accordingly respond to inquiries from relevant business and IT stakeholders and provide status updates on a frequent basis. Contribute and collaborate on CSV activities for enterprise level (multi-site projects), lab, and manufacturing systems. Work collaboratively to ensure the development of CSV best practices. Perform Software Period Reviews as scheduled. Job Requirements Minimum requirement is a Bachelorrsquos Degree in Computer Science, Sciences, or a related education. Minimum 5 years Professional experience in managing quality compliance in the regulated environments in a PharmaceuticalLife Sciences Organization. Proficiency in Computer System Validation in a GXP environment. Quality Assurance, GMPs, Health Authority Regulations and Validation practicesprinciples. Strong knowledge of GMP, GAMP5, SOPs and quality systems. Working knowledge of quality systems and regulatory requirements (21 CRF Part 11210211, ICH 8, ICH 9, ICH 10). Strong knowledge of IT compliance SOPs including change control practicesstrategies and system risk assessments. Proficient in MS Word, Excel, Power Point and other applications. Strong written and verbal communication skills. Ability to communicate and work independently with scientifictechnical personnel. Ideal candidate will have experience in validating software applications like SAP, MasterControl (MC), and ComplianceWire (CW).