Quality Assurance Specialist

Job Description

Join us as a Specialist Quality Assurance and become an integral part of our experienced Quality Assurance (QA) team. In the QA team, we ensure our wholesaling operations meet Good Distribution Practice (GDP) standards, and we continuously refine processes while keeping product quality and patient safety at the heart of everything we do. In this hands-on role you will support the local Quality Responsible Person (QRP)/Responsible Pharmacist with a variety of GDP-related tasks, collaborate with colleagues across functions and countries, work with distributors and liaise with Health Authorities. You will also have the chance to act as deputy to our QRP/Responsible Pharmacist, which is an influential position that offers broad visibility. We are offering an opportunity to grow your skills in a dynamic and international environment.

Responsibilities include:

• Acting as the deputy to the QRP/Responsible Pharmacist
• Creation and maintenance of Quality Management System procedures pertaining to the Quality/GDP area
• Oversight and support in management of outsourced GDP activities
• Involvement in the Product Quality Complaints process, e.g. performing summary reviews and reporting to local Health Authorities
• Handling of tasks related to deviations, CAPAs, recalls, self-inspections, product availability, change control and serialization
• Performing trainings of personnel and maintaining the local Quality training program
• Handling of batch-specific control for vaccines
• Supporting with various GDP related projects in the country organization or regionally/globally

Qualifications and Skills:

• Master of Science in Pharmacy degree
• Experience from a Quality Assurance or other GxP position in the pharmaceutical industry is an advantage
• Strong collaboration and communication skills, enabling effective collaboration in international and cross-functional teams as well as with external stakeholders
• Ability to work independently, lead your own work as well as good organization skills
• Ability to apply critical thinking, evaluate information and make informed decisions
• An understanding of the principles and guidelines of GDP, and knowledge of the relevant governing laws, regulations and provisions concerning medicinal products for human use
• Willingness to learn new technologies and adapt to changing requirements and expectations.
• Flexibility in handling shifting priorities and deadlines
• Experience using Veeva Vault, SAP and other GxP computerized systems is a plus
• Fluency in English

Why Join Us?

• Impact: Play a vital role in ensuring the safety and quality of medicines distributed across Hungary.
• Growth: Benefit from strong onboarding support, and be part of diverse local and regional projects to expand your QA expertise.
• Collaboration: Be part of a supportive, cross-functional team committed to excellence.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time. Our Quality Assurance group ensures every single product brought to market is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Preferred Skills:

Job Posting End Date:

• 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:R364126