Senior Specialist / Responsible Pharmacist Denmark – Marketing Company Oper

at  AstraZeneca

We are now hiring for a permanent Senior Specialist, MCOQ position including Responsible Pharmacist Denmark role. The position is based in Copenhagen, Denmark.
At AstraZeneca, you’ll have the chance to create a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.

MINIMUM REQUIREMENTS

• You hold a Master of Science degree in Pharmacy, showcasing your strong academic foundation.
• You bring valuable experience from the pharmaceutical industry, particularly in Quality Assurance, demonstrating your familiarity with industry standards and practices.
• You have hands-on experience in GMP/GDP and a solid understanding of the Quality environment, ensuring adherence to regulatory requirements.
• Your strong communication and influencing skills enable you to effectively collaborate with diverse teams and stakeholders.
• You are fluent in Danish and have an excellent command of English. A good understanding of other Scandinavian languages is a plus.

PREFERRED EXPERIENCE

• You have a background in similar roles within the pharmaceutical industry, research, pharmacies, or regulatory authorities, providing you with a comprehensive understanding of the field.
• You have experience working on cross-functional teams, demonstrating your ability to navigate and contribute to complex projects involving various departments and expertise.
• Ability to collaborate effectively both internally within the organization and externally with partners and stakeholders.

As a member of the Marketing Company Operations Quality (MCOQ) team, Senior Specialist is responsible for contributing to the design, implementation and delivery of a common Quality system and strategy for Good Manufacturing (GMP) and Good Distribution Practice (GDP) activities for all AstraZeneca products in the Nordic Cluster.
Responsible Pharmacist is the primary contact point for the Health Authorities and both external and internal stakeholders regarding the Good Distribution Practice (GDP), wholesale license and quality related issues such as product quality complaints, product defects and supply issues.

Here’s what you can look forward to:

• Key Contact for GMP/GDP: Serve as the go-to expert for GMP/GDP matters in Denmark.
• MCOQ Daily Operations: Oversee essential tasks such as managing temperature excursions, supply logistics, customer complaints, and investigating suspected falsified medicines alerts.
• Strategic Contributor: Play a critical role in shaping and executing our GMP/GDP strategies and activities.
• Regulatory Compliance: Ensure adherence to GMP, GDP, and all other relevant regulations, making sure we always meet the highest standards.
• GDP License Oversight: Take charge of the GDP license to operate, including participating in GMP/GDP audits and inspections, and implementing effective self-assessment program across the Cluster.
• Quality Management: Conduct self-assessments and contribute to maintaining and improving QMS compliance within the Cluster. Identify and escalate risks to Global Quality.
• Project Support/Lead: Assist in and lead regional and global projects, providing your expertise and insights.
• Procedure Development: Contribute to the creation of specialized procedures and offer technical input for developing global standards.
• Policy Implementation: Define, develop, deploy, and monitor GMP/GDP policies and standards within Cluster markets.
• Cross-Functional Representation: Represent Quality in cross-functional teams, ensuring a unified approach across Cluster markets.
• Process Optimisation: Support the global standardization, simplification, and improvement of MCOQ Quality business processes.
• High-Quality Delivery: Help build a high-quality organization that delivers consistent results while continuously improving competence, compliance standards, and innovative practices.
• Training and Support: Provide training, support, and coaching for regional Quality MCOQ network roles, fostering a knowledgeable and skilled team.
• Problem Solving and Future Planning: Engage in troubleshooting to resolve existing issues and anticipate future developments in AstraZeneca’s Quality needs.
• Quality Culture Ambassador: Promote a strong Quality Culture within the Marketing Company and locally, ensuring the execution of GMP/GDP excellence.