Overview
Senior Quality Systems Manager Jobs in Valais, Switzerland at ALTEN Switzerland
Title: Senior Quality Systems Manager
Company: ALTEN Switzerland
Location: Valais, Switzerland
ALTEN Group
Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 54,000 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.
Key responsibilities
Verification of the company’s compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
Provide immediate support to operations and quality control staff to address compliance related concerns (QA on-the-floor support).
Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
Audit internal quality system elements in manufacturing and operational support areas.
Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations. Perform external audits of suppliers/vendors/off-site facilities.
Act as a customer interface during on-site audits, conference calls and other standard means of communication. Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
Prioritize and manage a variety of projects simultaneously.
Review and approve validation documents.
Review and Master Batch Records (MBR) and supporting documents. Perform review/release of batch records, as needed.
Key requirements
Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
GMP compliance and Part 11 compliance knowledge preferred.
Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast paced environment; team oriented; independent work skills and a strong work ethic.
The ability to interface and communicate directly with clients is required.
Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
5-10 Years 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!
