QA Manager (12 months temporary contract)

Solvias; Kaiseraugst; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Solvias in Switzerland is seeking a Quality Management Software landscape owner and system administrator. You will support and train users, continuously improve and harmonize processes, and ensure SOPs and quality documents are up to date.

You will lead projects, implement additional QM modules, and collaborate across sites in a dynamic, cross-functional matrix environment while maintaining compliance with GMP, ICH, FDA, USP and Ph. Eur. standards.

Qualifikationen

• Background in analytical chemistry/biochemistry/life science.
• Experience in analytical-pharmaceutical environment, preferably QA.
• Ability to lead projects and collaborate with diverse stakeholders.

Aufgaben

• Owns the quality management software landscape as system administrator.
• Supports and trains users on the QM software.
• Continuously improves and harmonizes processes and SOPs.
• Updates and harmonizes SOPs and documents.
• Leads projects and implements additional modules/functions within QM software.
• Works across sites in a dynamic matrix environment.

Kenntnisse

Quality systems

Stakeholder mgmt

Project leadership

Cross-functional

SOP understanding

Documentation

System administration

Ausbildung

Life science degree

Tools

QMS software

GxP tooling

Jobbeschreibung

Job Description

In this role, you take ownership of our quality management software landscape and act as the system administrator. You support and train users, continuously improve and harmonize processes, and ensure that SOPs and quality documents are always up to date.

Job Description

In this role, you take ownership of our quality management software landscape and act as the system administrator. You support and train users, continuously improve and harmonize processes, and ensure that SOPs and quality documents are always up to date.

Responsibilities

• Taking care of the quality management software as system administrator
• Support and train users
• Improve and update processes including update of relevant SOPs and documents
• Harmonization of processes
• Leading projects
• Implementing additional modules / functionalities within the quality management software

Qualifications

• Background in analytical chemistry/ biochemistry/ life science
• Experience in the analytical-pharmaceutical environment, preferably experience in QA
• Skills to solve the problems and build a good relationship with various stakeholders
• Good interpersonal skills and team work spirit
• Ability to collaborate in a dynamic, cross-functional matrix environment
• Ability to lead projects between sites and work independently
• Broad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph. Eur.)
• Solid background in data integrity and computerized systems risk assessment and project support
• Experience as system administrator or deeper IT knowledge is an asset
• Fluency in English and German as a plus is required

About Us

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards