Senior Quality Engineer m/f/d

The QA Expert operates within the Quality organization at the Neuchâtel site, providing quality oversight and ensuring compliance across the manufacturing and release lifecycle of Bulk Drug Substance (BDS).

This role is responsible for maintaining adherence to GMP standards, regulatory requirements, and internal quality systems, while supporting continuous improvement initiatives and operational excellence. The QA Expert acts as a key quality representative for both routine operations and improvement projects.

Type of employment: Payroll

Industry: Biotech

Skills: Aseptisch,Quality

Project start: 01.05.2026

Project duration: 30.09.2026

Tasks:

Release Activities

• Perform inspection and release of raw materials and external BDS
• Maintain and update release planning activities
• Contribute to KPIs related to raw material release performance
• Ensure proper archiving of release documentation

Documentation Management

• Prepare, review, and approve controlled documents (SOPs, procedures, specifications, forms, etc.)
• Ensure timely updates and compliance of all documentation
• Drive continuous improvement of documentation in collaboration with SMEs

Deviation & CAPA Management

• Lead, review, and approve deviations related to manufacturing and laboratory activities
• Conduct or oversee investigations, impact assessments, and root cause analysis
• Define and implement corrective and preventive actions (CAPA)
• Ensure timely closure and compliance of deviation and CAPA records
• Apply structured problem-solving methodologies and tools

Change Control

• Evaluate and manage internal and external change requests
• Act as approver for routine and emergency changes
• Ensure changes are implemented in line with GMP and regulatory requirements
• Support documentation, tracking, and timely closure of change controls

Quality Oversight in Operations

• Provide on-the-floor QA support and guidance to production teams
• Ensure strict application of cGMP principles and quality standards
• Participate in daily operational decision-making, including on-call support
• Identify and escalate quality risks and propose corrective actions
• Collaborate cross-functionally (Production, QC, Engineering, Maintenance)
• Lead or participate in cross-functional meetings and improvement initiatives

Audits & Inspections

• Participate in GMP area audits
• Support internal and external regulatory inspections

EHS (Environment, Health & Safety)

• Ensure compliance with company EHS policies and guidelines
• Promote a safe working environment
• Report risks and improvement opportunities

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, or related field
• Proven experience in Quality Assurance within a GMP-regulated pharmaceutical or biotech environment
• Strong knowledge of cGMP, regulatory requirements, and quality systems
• Experience in deviation handling, CAPA, and change control processes
• Familiarity with manufacturing and release of drug substances (BDS preferred)