ALTEN Group
Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 58,000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.
ALTEN Switzerland
Since 2005, with 450 current employees, ALTEN Switzerland is a reference partner in providing Engineering services to 100 world leading companies. ALTEN Switzerland’s activities cover all the main strategical areas of the Swiss market in Life Sciences, Engineering & IT Services.
Role Description
The QA Validation Specialist is responsible for supporting all activities that ensure critical GMP (Good Manufacturing Practice) equipment, facilities, and/or systems are properly validated and consistently maintained in compliance with:
User requirements
Process parameters
Global regulatory guidelines
Key Responsibilities
Collaborate closely with Operations, Quality Assurance, clients, and regulatory bodies to provide scientifically sound and well-documented evidence that systems and processes perform reliably and compliantly.
Ensure the manufacturing environment adheres to strict quality and compliance standards.
At this level, the Specialist must demonstrate a comprehensive understanding of Qualification and Validation processes and act as a resource for junior team members .
Oversight & Execution:
Provide QA oversight during Validation reviews and Qualification activities to ensure that GMP equipment, facilities, and/or systems remain in a continuously qualified and validated state .
Manage and schedule tasks for oneself and for Level I Specialists, as assigned by the Validation Manager .
Conduct change control assessments related to GMP equipment, facilities, and systems, ensuring validation activities remain compliant with regulatory requirements.
Technical Expertise
Apply a thorough understanding of Cell and Gene Therapy manufacturing systems, including:
Installation Qualification (IQ)
Autoclaves
Clean Utilities
Shipping Validation
Temperature Mapping
Controlled Storage Rooms and Equipment
Develop validation protocols based on validation plans (when applicable).
Provide strong technical insight during the review and approval of:
Standard Operating Procedures (SOPs)
Protocols
Reports
Change controls
Deviations
Other GMP documentation
Quality Systems Involvement
Perform assigned tasks within various Quality Systems, including but not limited to:
Document Management System (DMS)
Laboratory Information Management System (LIMS)
Validation and Qualification Management System (Kneat)
TrackWise (handling Change Controls, Deviations, CAPAs, etc.)
Additional Information
Perform other duties as assigned by leadership.
Education & Experience Requirements
Education : Bachelor’s degree in a scientific or technical discipline.
Experience : 2 to 6 years of experience in the pharmaceutical industry, including entry-level experience.
What we offer you
At ALTEN, we offer you the security of a permanent contract while also giving you the liberty to work with multiple prestigious clients. With the luxury of having a wide range of offices around the world, we are in a unique position to provide you with the freedom to experience national and international business opportunities. Thus, we function in a highly innovative market, always being up to date with the latest technologies and making you a pioneer in your field.
Therefore, we offer our employees sought-after trainings and workshops ranging from hard to soft skills and providing you with certificates that will further increase your qualifications, enabling you to participate in ground-breaking projects.
Apply now and be a part of our amazing journey. We believe in growing together!
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