Senior Quality Assurance Professional

vor 1 Woche


Kaiseraugst, Aargau, Schweiz Solvias AG Vollzeit

Solvias AG is an internationally recognized provider of integrated solutions in contract analytical research, development, and manufacturing. The company offers a wide range of services and solutions across the Pharmaceutical, Biotech, Medical Device, Cell&Gene Therapy, and Cosmetic industries.

Job Overview

This role focuses on ensuring the highest quality standards are met across various projects. As a Senior Quality Assurance Professional, you will be responsible for reviewing and approving SOPs, protocols, reports, and other quality documents. Your attention to detail and analytical skills will play a crucial role in maintaining our reputation for excellence.

Responsibilities
  • Review and approval of SOPs, protocols, reports, and Certificate of Analysis
  • Support quality investigations of deviations and Out of Specification (OOS) events
  • Maintenance, recording, and processing of corrective and preventive measures (CAPA)
  • Performing internal audits
  • Organization and management of customer audits and inspections
  • Application and interpretation of audit and compliance requirements
  • Act as QA point of contact for customers
  • Support for GMP training
Requirements
  • Scientific education (Master degree) in analytical chemistry, biochemistry, or life science
  • Multi-year, industrial work experience of 7 years minimum in the analytical-pharmaceutical environment, preferably in QA
  • Strong problem-solving skills to meet business objectives
  • Excellent interpersonal skills and teamwork spirit
  • Ability to collaborate in a dynamic, cross-functional matrix environment
  • 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 an auditor is an asset
  • Fluency in English and willingness to learn German is required
Compensation Package
  • A competitive annual salary of approximately CHF 90,000 - CHF 110,000 based on qualifications and experience
  • Flexible work models such as part-time and remote work
  • Minimum 28.5 vacation days
  • Monthly child allowance above the Swiss minimum
  • Voluntary monthly family allowance
  • Various pension fund solutions
  • Daily allowance insurance and non-occupational accident fees paid by Solvias
  • Reka cheques
  • Commuter contribution for using public transport
  • Employee discount programs for fitness, insurance, retail, and more
  • Onsite canteen


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