Senior QP & Quality Assurance Specialist

Merck; Wien; On-site; EUR 55,000 - 67,000; Full time

Benefits offered by this job

Annual bonus

Company pension

Vaccination program

Canteen subsidy

Health/medical care

Job summary

Merck Vienna site seeks a Qualified Person (m/f/d) to oversee batch release and ensure GMP compliance for solid drug manufacturing. The role includes product quality review, COA/CoC issuance, and contributing to inspection readiness within a global project framework.

Requirements include a Master’s in scientific education, QP certification, and strong German/English communication with GMP experience. Competitive salary and benefits offered in Vienna.

Qualifications

• Master's degree in scientific education required.
• QP certification required.
• Strong GMP knowledge and regulatory understanding.
• Excellent written and verbal communication in German and English.

Responsibilities

• Batch Release.
• Usage Decision for Bulk, FPU and FPP based on product training.
• Ensure batches manufactured per GMP and regulatory standards.
• Issue CoAs and CoCs for Bulk, FPU and FPP.
• Review product quality reports and deviations; manage CAPAs.
• Manage QP and QAO related document creation, review and approval.
• Support site inspections readiness and global projects.

Skills

Communication skills

German and English

Organizational skills

Analytical abilities

Judgement and confidence

Education

Master's degree in scientific education

QP certification

Job description

Merck Vienna site seeks a Qualified Person (m/f/d) to oversee batch release and ensure GMP compliance for solid drug manufacturing. The role includes product quality review, COA/CoC issuance, and contributing to inspection readiness within a global project framework.

Requirements include a Master’s in scientific education, QP certification, and strong German/English communication with GMP experience. Competitive salary and benefits offered in Vienna.