Sr. Spclst, Quality Assurance

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

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that is devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Our site in 1210 Vienna is a strategic location for solid drug manufacturing including tablets, coated tablets, granules and implants for the health provision and treatment of livestock and domestic animals. Most of our products are exported. To ensure sustainable company growth we continually strive to offer attractive career opportunities for more than 450 employees at our Vienna site. In support of our existing team, we are currently looking for a:

Qualified Person (m/f/d)

We are looking for a Qualified Person (m/f/d) according to Austrian "Arzneimittelbetriebsordnung 2009" and EU “Guide to Good Manufacturing Practice Annex 16".

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.

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
• General:
• 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

Qualifications, Experience & Skills

• 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

We offer

• Exciting and varied field of work in a modern, internationally operating company
• Annual bonus and employee recognition bonuses
• Employee referral program
• Attractive company pension
• Paid parental leave up to 12 weeks provided by company
• Company medical care and vaccination program
• Discounted fitness offer
• Fruit, coffee & tea
• Massage@Work
• Modern company canteen with generous company subsidy
• Annual ticket for Wiener Linien or subsidy for climate ticket and/or bike leasing
• Various employee discounts and benefits and much more!

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 61.300 and varies according to the qualifications and experience of the successful candidate. We are looking forwa

Additional location(s) Compensation Information

Required Skills:

• Document Productions
• GMP Documentation
• Good Manufacturing Practices (GMP)
• Inspection Readiness
• Product Inspections
• Quality Auditing
• Quality Inspections
• Quality Management Standards

Employee Status

Regular

Flexible Work Arrangements

Not Applicable

Job Posting End Date

12/1/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.