QA Operations Specialist II

About the role

The QA Operations Specialist II ensures GxP documentation across production, engineering, warehouse and laboratory functions meets regulatory standards. You will support quality‑focused projects, audits and continuous improvement initiatives within Sandoz’s pharmaceutical environment.

Key responsibilities

• Review and approve electronic batch records.
• Review and approve system/equipment qualification and validation in line with EU Annex 11 & 15 and 21 CFR Part 11.
• Manage production and engineering deviations, CAPA and change control processes.
• Maintain compliance and control throughout system life‑cycle management.
• Ensure GxP compliance, data integrity and good documentation practices for all activities.
• Support inspections and audits and contribute to the internal quality management system.
• Prepare, review and approve operational procedures within the area of expertise.

Required profile

• University degree in Biotechnology, Microbiology or related field (or secondary school with minimum 5 years relevant experience).
• Basic knowledge of English.
• Experience in production, development or quality functions in a pharmaceutical setting is preferred.

Required skills

• GxP documentation review and approval.
• Electronic batch record handling.
• System/equipment qualification and validation (EU Annex 11 & 15, 21 CFR Part 11).
• CAPA, deviation and change control management.
• Data integrity and good documentation practices.

What we offer

• Permanent contract with a 6‑month probation period.
• Hybrid work environment with remote flexibility.
• Annual gross salary range €30,960 – €46,440.
• Annual bonus, vacation allowance, Christmas bonus and share ownership.
• Fully funded supplementary pension plan and comprehensive life & accident insurance.