For our international partner, Roche Diagnostics International Ltd. based in Rotkreuz, we are looking for a qualified and motivated Validation Lead for 6 months with option for extension.
In this role you will be responsible for driving the validation approach for the Manufacturing Execution System (MES) part of a newly established production line for Roche Diagnostics sensor production.
We need you to author and provide oversight to system validation documentation throughout the software lifecycle with a focus on compliance to Health Authority regulations. You should ensure that all validation deliverables in projects and operations are created and appropriately maintained in accordance with Computerized System Validation (CSV), and review defects and deviations during testing to ensure they are documented and closed and provide support to IT operations teams by assessing the impact of changes on the validated state of the system.
- Ensure that the Computer System Validation on the project is conducted in a consistently high standard, and that objectives are met on time suiting the company's vision and objectives
- Lead and be an active part in the development of documents, processes, and procedures of the Computer Systems Validation (CSV) program
- Generate, review, and approve Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
- Provide regulatory and retention requirements
- Ensure that Roche specific guidelines for CSV are followed by our project
- Coordinate with Computer System vendors as needed
- Assess the impact of Computer System modifications and maintain change control
- Ensure all project related risks are well managed and deliverables are validated (for GxP) /tested (for non%u2010GxP) in accordance to Roche Standards and SOP’s and the associated CSV requirements
- Ensure project team complies with the methodology and SOP and uses the correct tools
- Ensure all project related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
- Prepare project and life%u2010cycle reports and review/approve all other documents to ensure compliance with SOP
- Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in document repository (Document Navigator) and approved in accordance to the prescribed SOP
- Several years of professional experience as a Validation Lead in a project environment, preferred in a matrix organization
- At least 10 years of professional experience with Computer System Validation experience in a GxP Pharmaceutical / Diagnostics facility
- Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11
- Hands-on experience in development and review of computer validation documentation
- Very good command of English
- Willingness to collaborate with international colleagues and cross-functional teams to achieve company and departmental objectives
- Excellent communication skills
- Ability to work as a team player in a consulting environment
- Able to maintain direct relationship with stakeholders and project team members
- Proactive approach
Nice to Haves
- German is beneficial
- Previous Roche Diagnostic experience
Are you interested? Do not hesitate and submit your complete application documents online today.
We value diversity and therefore welcome all applications - regardless of gender, social orifin, religion/belief, age or identity.
We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!