Validation Lead (f/m/d)

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Schlagworte

Program Assessment Rating Tool (PART) Diagnostische Fähigkeiten 21 Cfr Automatisierung Steuerungssysteme Traceability Pharmazie Biologie ISO 9000 Change Control Kommunikation Beratung It Operations Manufacturing Execution Systems Softwareentwicklung Teamarbeit GXP

Beschreibung

Validation Lead (f/m/d) - matrix /GxP / 21 CFR Part 11 / Annex 11 / German

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Validation Lead
Background:
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.
The perfect candidate:
We are looking for a candidate who has strong CSV experience but also in Automation Control Systems, Manufacturing & IT Systems. We are looking for a senior candidate who has a strong background and a hands-on personality who can work independently and is proactive.
Tasks & Responsibilities:
* 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?GxP) 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?cycle 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.
Must Haves:
* Min. 3-5 years of experience as a Validation Lead in a project environment, preferred in a matrix organization
* Min. 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
* Fluency in English and proficiency (spoken and written)
* Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
* Excellent communication skills
* Ability to work as a team player in a consulting environment
* Able to manage direct relation with stakeholders and project team members, give guidance
* Proactive approach
Nice to have:

German is beneficial
* Previous Roche Diagnostic experience

Reference Nr.: 922113SGR
Role: Validation Lead
Industrie:Pharma
Workplace:Rotkreuz
Pensum: 100%
Start: 01.12.2022
Duration: unlimited
Deadline: 14.11.2022

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: .

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.
Start
12/2022
Von
ITech Consult AG
Eingestellt
08.11.2022
Projekt-ID:
2492855
Vertragsart
Freiberuflich
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