Qualified Person / Senior Specialist Quality Assurance (m/f/d) at Merck Sharp & Dohme Corp. /Netherlands

Vienna, , Austria -

Full Time

Start Date

Immediate

Expiry Date

16 Oct, 26

Salary

0.0

Posted On

18 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Regulations, Change Management, Deviation Management, GMP Compliance, Inspection Readiness, Pharmaceutical Quality Assurance, Problem Solving, Product Disposition, Quality Assurance, Quality Auditing, Quality Management, Regulatory Compliance, German Language, English Language, Analytical Abilities, Organizational Skills

Industry

Pharmaceutical Manufacturing

Description

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 / Senior Specialist Quality Assurance (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" 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 Mange, 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 company's 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 forward to receiving your application. Required Skills: Adaptability, Adaptability, cGMP Regulations, Change Management, Deviation Management, German Language, GMP Compliance, Good Automated Manufacturing Practice (GAMP), Inspection Readiness, Manufacturing Quality Control, Oral Communications, Pharmaceutical Quality Assurance, Problem Solving, Product Disposition, Quality Assurance (QA), Quality Assurance Monitoring, Quality Assurance Processes, Quality Assurance Review, Quality Assurance Testing, Quality Auditing, Quality Control Management, Quality Management, Quality Management Standards, Quality Standards, Regulatory Compliance {+ 2 more} Preferred Skills: 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: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): NA Job Posting End Date: 08/18/2026 *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.

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Responsibilities

Responsible for batch release and usage decisions for bulk and finished products ensuring compliance with GMP and regulatory requirements. Manages quality-related deviations, CAPAs, change controls, and product quality complaints.