MSD Quality Assurance Senior Specialist 

Denmark, Capital Region of Denmark 

234319998

Job Description

In the QRP role, you will work closely with the Quality Assurance Specialist in Denmark who will report to you. You will interact with a broad range of internal and external stakeholders including global internal functions, distributors, and Health Authorities. As a QRP, 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 be able to develop yourself professionally in an international environment.

Responsibilities will include e.g.:

• Collaboration with local management and conducting regular Management Quality Review meetings.
• Forming strong partnerships with stakeholders and represent the company in relevant external forums.
• Creation, development and maintenance of Quality Management System procedures and trainings.
• Oversight of Product Quality Complaints and alerts originating from Denmark.
• Handling of deviations, CAPAs, recalls, self-inspections and change control.
• Oversight of local distributors and other outsourced GDP activities and management of related Quality Agreements.
• Maintenance of the local Quality training program and performing trainings of personnel.
• Participating in cross-functional teams where GDP expertise is needed.
• Handling of batch-specific control for vaccines (batch commercialization)
• Maintaining the subsidiary in a state of GDP inspection readiness and host GDP audits and inspections
• Risk management and risk-based decision making to safeguard product quality, GDP compliance and patient safety.

Qualifications & Skills:

• Master Degree in Pharmacy or equivalent
• In-depth knowledge of Danish and EU GDP regulations and guidelines
• Demonstrated experience of GDP/quality management from a Quality Assurance position in the pharmaceutical industry (at a minimum two years)
• Strong analytical and problem-solving skills
• Strong leadership skills and ability to lead your own work as well as providing guidance and support to others
• Detail-oriented mindset with a focus on maintaining accurate records and documentation.
• Excellent interpersonal and communication skills and experience of managing relationships with regulatory authorities
• Highly organized with the ability to prioritize tasks and manage multiple responsibilities.
• Continuous learning mindset to stay updated with the latest regulatory changes and industry developments.
• Proficiency in Danish and English

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.

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.