Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

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:

Senior Specialist Quality Assurance, Qualified Person (m/f/d)

Main Responsibilities:

Qualified Person according to Austrian "Arzneimittelbetriebsordnung 2009" and EU Guide to Good Manufacturing Practice Annex 16"

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

Assess product quality related deviations and CAP As

Review and approve product quality reports

Manage QP and QAO related document creation, review and approval

Contribute to Inspection Readiness for the Vienna site

Attend conferences and trainings as required to maintain proficiency

Compliance with EHS regulations, reporting of dangerous situation, near misses and sources of danger in the working environment

Requirements:

Master's Degree in Scientific education

Qualified Person (QP) certification, according to Austrian "Arzneimittelbetriebsordnung 2009" and EU Guide to Good Manufacturing Practice Annex 16

Significant work experience in quality department and GMP knowledge Regulatory and governance

Product Quality and compliance knowledge

Excellent written and verbal communication skills (German & English)

Solid organizational skills,  problem Solving and analytical skills

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 forward to receiving your application.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/7/2025

*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.

Requisition ID:R337520