Validation Lead (m/f/d)

REFERENCE NUMBER:

656530/1

MY DUTIES:

- 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 specific guidelines for CSV are followed by the 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 the company's 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.

MY QUALIFICATIONS:

- Experience as a Validation Lead in a project environment, preferred in a matrix organization
- 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

MY BENEFITS:

- A very renowned company
- You will work in an international environment

ABOUT HAYS:

IT is and always has been our core business that laid the foundation for Hays' success. We are the biggest privately owned IT recruitment agency in Germany and offer the best jobs for every career level – whether you are interested in vacancies in agile SMEs or international DAX groups. Hays masters the entire IT job spectrum, from support to software architecture or digitalisation – thanks to our broad portfolio, we have something for everyone. In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet! We look forward to hearing from you.

MY CONTACT AT HAYS:

My contact person
Konstantina Glykou

Reference number
656530/1

Contact
E-Mail: [email protected]