CSV Lead
Share
Job Location:
Raritan, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Details:
Experience in the Pharmaceutical biotechnology or medical device industry
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.
Knowledge of FDA guidances and industry standards i.e. GAMP
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 onsite at Raritan NJ
Experience in the Pharmaceutical biotechnology or medical device industry
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.
Knowledge of FDA guidances and industry standards i.e. GAMP
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 onsite at Raritan NJ
Key Skills
- Administrative Skills
- Facilities Management
- Biotechnology
- Creative Production
- Design And Estimation
- Architecture
