Validation Expert Consultant

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We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998,with more than 1500 employees, 45+ nationalities and 28 subsidiaries all over the world(Europe, Asia and the Americas). Joining PQEmeans being a part of a multicultural and challenging company, with many local and international projects, and colleagues from all over the world.

Due to a constant growth, PQE is looking for a Validation Expertbased in Vevey, Switzerland who will be responsible for conducting CSV and QA related activities according to the required CGMP regulations.

Responsibilities include, but are not limited, to the followings:

• Resolution of fundamental CSV compliance issues
• Align with e‐Compliance on project management and life cycle documentation deliverables for GxP relevant projects
• Qualification of sterile, oral production equipment and supporting systems (IQ, OQ, PQ) as well as Building Management System and Access Control System. Executing FATs and SATs.
• alidation Lead for Werum PAS-X Electronic Batch Record Project (MES)
• 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 SOP and uses the correct tools
• Ensure completeness and consistency of project life cycle documentation
• 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

Requirements:

• At least 3 years of Computer System Validation or any validation experience required (sterile, oral production equipment)
• Experience in Pharmaceutical Sector
• Excellent prioritization, communication and stakeholder management skills
• Proficiency with MS Office tools
• Full availability to travel domestically and internationally: up to 75%

Nice to have:

• Experience in any other validations (i.e. equipment validation, process validation,)
• Knowledge of software like PSpice, Matlab, Proteus, PAS-X, Maximo, Qmex
• Proficiency in other languages (German, French, Turkish) will be a plus

Full-time Job

Location: Vevey, Switzerland

Our collaborators are engaged, developed, challenged and well-rewarded for performance.

We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.