MSD Quality Assurance Specialist 

Denmark, Capital Region of Denmark 

558419153

Job Description

We are seeking a Quality Assurance Specialist to join our team in Denmark. As a Quality Assurance Specialist in our Company in Denmark you will be a key contributor in a team consisting of quality professionals in the Nordic countries, Ireland and the UK. In the team, we focus on ensuring company compliance with external and internal requirements pertaining to wholesaling activities/Good Distribution Practices (GDP). You will work closely with, and act as deputy for, the Quality Responsible Persons (QRPs) in Denmark and Norway. You will also interact with a broad spectrum of internal and external stakeholders including global internal functions, customers, and Health Authorities. In this role, you will be empowered to influence and improve processes and engage in matters that are important for the quality of our medicinal products. You will also get the opportunity to develop yourself professionally in an international environment.

Responsibilities of this role include:

• Creation, development and maintenance of Quality Management System procedures and training materials pertaining to the Quality/GDP area.
• Handling of tasks related to deviations, Corrective and Preventive Actions (CAPAs), recalls, destruction, risk management and change controls.
• Acting as a deputy for the QRPs in Denmark and Norway.
• Oversight of Product Quality Complaints, falsified medicines and alerts originating from Denmark and Norway.
• Ensuring batch-specific control for vaccines (batch commercialization).
• Providing oversight of distributors and other outsourced GDP activities.
• Conducting trainings of personnel.
• Maintaining the subsidiary in a state of GDP inspection readiness.
• Supporting self-inspections, audits and inspections of the local offices.

To succeed in this role, you should have the following qualifications and experience:

• Master of Science in Pharmacy or equivalent degree.
• Experience in Quality Assurance related to GDP is considered a plus.
• Proficiency in Danish, English and good understanding of Norwegian.
• Strong attention to detail with a focus on maintaining records and documentation accurate.
• Proficiency in various IT system tools.
• Ability to lead your own work in a team which spans across several countries.

Our Quality Assurance group ensures that products are stored and distributed in accordance with our quality standards and meet applicable regulatory requirements. Partnering across our internal manufacturing facilities and suppliers, we create an interdependent global network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:10/01/2024

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.