Validation Lead (f/m/d)

Validation Lead (f/m/d) – CFR / Data Integrity / GMP / Annex11 / GAMP5

Projekt:
For our client in the Roche Rotkreuz based in Rotkreuz we are looking for a Validation Lead (f/m/d)

Background:

In that role you will be responsible to determine the validation approach for a newly Manufacturing Execution System (MES), author and provide oversight to system documentation throughout the software validation as well as prepare the lifecycle of this software with a focus on compliance to Health Authority regulations. Ensure that all validation deliverables in projects and operations are created and appropriately maintained in accordance with Computerized System Validation (CSV), listing pending issued the impact of changes on the validated state of the system and follow up on defects and deviations.

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 take 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.
* 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 SOP and the associated CSV requirements.
* Ensure project team complies with the methodology and Roche standards 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
* Experience 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 Haves
* University degree in Engineering, Computer Science or any related environment
* German language skills would be an advantage
* Roche experience

Reference No.: 921237SGR
Role: Validation Lead
Industry: Pharma
Location: Rotkreuz
Workload:100%
Start: 01.04.2022
Duration: 6++
Deadline: 10.03.2022

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.

Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.

About us:

ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.