Senior Quality Assurance & QP Specialist (GMP)

MSD; Wien; On-site; GBP 46,000 - 56,000; Full time

Benefits offered by this job

Annual bonus

Employee referral program

Company pension

Parental leave

Medical care

Fitness discount

Massage@Work

Canteen subsidy

Transport subsidy

Employee discounts

Job summary

We are seeking a Qualified Person (m/f/d) in Vienna to oversee batch release, regulatory compliance and product quality for GMP manufacturing of biopharmaceuticals. The role requires a Master’s degree in science, QP certification and extensive GMP experience, with strong German and English communication skills.

The position involves ensuring compliance with Austrian regulations and EU guidelines, contributing to inspection readiness, and supporting global quality projects.

Qualifications

• Master’s degree in scientific education.
• QP certification.
• Significant work experience in quality department and GMP knowledge.
• Strong knowledge of regulatory and governance requirements.
• Understanding of product quality and compliance.
• Broad industry knowledge.
• Excellent internal and external communication skills.
• Strong written and verbal communication skills in German and English.
• Solid organizational and planning skills.
• Strong problem-solving and analytical abilities.
• Good judgment, discipline, and confidence.

Responsibilities

• Batch Release
• Usage Decision for Bulk, FPU and FPP based on product specific training
• Assure that each batch was manufactured according to GMP and all other applicable regulations including respective marketing authorization
• Issue CoAs and CoCs for Bulk, FPU and FPP
• Routine: Assess product quality related deviations and CAPAs
• Assess product impact in change control
• Manage, review and approve product quality complaints
• Review and approve product quality reports
• Manage QP and QAO related document creation, review and approval
• Product Quality support in site and global projects
• Contribute to Inspection Readiness for the Vienna site
• Attend conferences and trainings as required to maintain proficiency
• Compliance with EHS regulations, reporting of dangerous situations, near misses and sources of danger in the working environment
• Compliance with our ethical guidelines and global standards as applicable
• Additional role
• Perform any other duties as assigned management on an as-needed basis

Education

Master’s degree in scientific education

Job description

We are seeking a Qualified Person (m/f/d) in Vienna to oversee batch release, regulatory compliance and product quality for GMP manufacturing of biopharmaceuticals. The role requires a Master’s degree in science, QP certification and extensive GMP experience, with strong German and English communication skills.

The position involves ensuring compliance with Austrian regulations and EU guidelines, contributing to inspection readiness, and supporting global quality projects.