Quality Project manager

About the job

Join a dynamic international pharmaceutical company where you can apply your scientific background and project management expertise in a highly regulated environment. We are looking for a professional who confidently navigates GMP frameworks can coordinate complex projects and enjoys collaborating with global and local teams. If you are motivated to grow think in systems and actively contribute to the companys quality objectives this role is an excellent fit for you.

General Responsibilities

• Professional tasks shall be executed in accordance with the current Hungarian international (OGYÉI FDA ICH Q7 etc.) and company requirements and rules.
• Adhering to and ensuring adherence to EHS and KIR / MEBIR requirements and current standards.
• Participation in the professional and GMP trainings.
• Participation in the customer and authority inspections.
• Participation in the configuration development and maintenance of the documentation system.
• Keeping contact with other departments in reference to the job.
• Participation in commercial and R&D activities.
• Execution of other oral and written tasks of superiors.
• Inform immediate superior about any non-conformities (deviation OOS) which were detected during activity.

Special Responsibilities

• Participate in global and local projects in co-operation with other departments including R&D activities.
• Lead the QSB related part of local and global projects.
• Keep the contact with global functions global project managers in accordance with the project related QSB tasks.
• Keep the Manager updated regularly.
• Personal responsibilities as laid down and regularly updated in PMP.
• Participation in change controls initiation of relevant changes.
• Support the determination of quality related KPIs.
• Ensure regular follow up of different activities as per actual business interests including R&D activities.
• Support the QSB budget planning and cost monitoring YTD based on planned /executed project related part.
• Ensure using of the tools supported by the Xellia for managing the QSB related projects.
• Participation of Xellia global project management trainings. Ensure the local development and implementation by local trainings.
• Active support in workload forecast for the non-commercial activities.

Requirements

• University degree in a science or technology field.
• Minimum 5 years of experience in the pharmaceutical industry including significant project management experience.
• Fluent business-level English language skills.
• Strong coordination communication and organizational skills.
• Experience working in a GMP-regulated environment.

What we offer

• Competitive salary and benefits package including free access to multiple gyms in Budapest and regular health screenings.
• Opportunities for continuous learning growth and development.
• Flexibility with 2 days of home office per week.
• A supportive team environment with friendly motivated colleagues.
• The stability of an international company with a dynamic multinational culture.

Xellia Pharmaceuticals is the global leader in fermentation-based non-beta-lactam anti-infectives supplying Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries.

Recognized by the World Health Organization and the European Union for our critical medicines we play a vital role in combating severe infections and antimicrobial resistance. Headquartered in Denmark we operate manufacturing sites in Copenhagen Denmark; Budapest Hungary; and Taizhou China with R&D and commercial operations in eight additional locations globally. As the only European manufacturer of several key anti-infectives and with a heritage spanning over 120 years we are driven by purpose and progress.

With more than 1100 employees our impact starts from within. We offer a workplace where ideas curiosity and initiative thrive and where your role evolves with your ambition. Instead of rigid structures we provide real responsibility freedom to explore and support to grow. Together we shape not only the future of our company and the development of our people but also the health of communities worldwide.

Further information about Xellia can be found at:
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