Production Support Specialist (On-site, Denmark)

Job summary

This position involves supporting vaccine manufacturing operations in a regulated environment, ensuring compliance and efficiency in collaboration with contract manufacturing organizations (CMOs). The role is based in Kvistgaard, Denmark, and is a temporary position for 18 months.

Qualifications

• Relevant degree (BSc or higher) in pharmacy, chemistry, (bio)engineering, or equivalent.
• Solid experience in a similar role within a GMP regulated industry.
• Experience with quality management systems, such as Veeva.
• Strong communication skills in English, both verbal and written.

Responsibilities

• Act as the first point of contact for operational challenges and quality events at the CMO.
• Ensure GMP compliance and operational excellence across manufacturing activities performed by CMOs.
• Lead investigations, root cause analyses, and implement corrective and preventive actions, ensuring documentation adheres to GDP.
• Drive performance improvement through process monitoring, trend analysis, and KPI management.
• Collaborate with internal stakeholders and CMOs to support reliable product supply and inspection readiness.

Skills

• Strong understanding of aseptic operations and unlabeled drug product processes.
• Structured problem-solving mindset with a high degree of ownership and accountability.

Education

• BSc or higher in pharmacy, chemistry, (bio)engineering, or equivalent.

Tools

• Quality management systems like Veeva.