Quality Assurance Specialist

Placering
Copenhagen
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.

Join us in our commitment to quality and make a difference in the lives of patients. Apply now to become part of our dynamic team as a Quality Assurance Specialist.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
10/1/2024*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.

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.

Requisition ID:R311887