Corporate Quality Specialist
Corporate Quality Specialist
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Job Description
Quality
About the job
At Xellia the Corporate Quality Systems (CQS) team plays a vital role in shaping and strengthening the foundation of our global Quality Management System. We work across all sites and functions to ensure regulatory compliance drive continuous improvement and support the delivery of safe effective medicines to patients worldwide.
As part of the CQS team youll join a dynamic international group of experts dedicated to building robust processes developing global standards and maintaining inspection readiness across the organization. This is a unique opportunity to collaborate with key stakeholders influence company-wide quality practices and contribute directly to Xellias mission of safeguarding lives.
If you are an ambitious Quality expert who wants to influence the compliance level across Xellia sites your next challenge starts here!
Main Responsibilities:
- Interpret build upon and comply with the company quality assurance standards
- Identifying defining implementing and collect and inspect data to measure/manage process performance
- Elaborate recommend and oversee improvement actions
- Develop new standards for stakeholders (Production QA QC etc.) and design with improvements as needed and creating procedures across all service lines
- Work with the Quality functions to design and maintain clear workflows and processes
- Prepare and review Xellias SOPs related to CP
- Ensure that Xellias Global system is always inspection ready
- Elaborate GMP procedures (API/FDF) and guidelines to improve Quality Management System (QMS) at Xellia
- Develop and create process training materials and roll-out plans to all sites
- Measure and manage process performance
- Participate in various projects and activities within CP
- Escalate compliance issues to immediate superior with potential/sizeable impact/risk to Xellia Pharmaceuticals business/company reputation.
- Act as Subject Matter Expert (SME) during customer audits/regulatory inspections
- Act as Process owner for Global Quality Systems (Trackwise myProcess and vLMS etc.)
Other requirements:
- The position requires travelling to Xellia sites
- Applicants must be based in Budapest
- Close co-operation with the rest of the CQS team and Xellia sites team
What we expect:
- Minimum 5 years of experience in the pharmaceutical industry and has worked in different areas of Quality preferably also in Operations
- Should have experience in Analytical assurance Quality control activities and analytical data review
- With chemistry / science background e.g. Pharmacy Chemical engineering etc.
- Strong cGMP and pharmaceutical knowledge and experience required: FDA/EMA or other regulatory experience preferred be able to identify compliance gaps in Xellia sites and provide solutions to close the gaps
- Strong communication skills
- Collaborates well with stakeholders
- Team player and independent contributor
What we offer:
- You will have a lot of impact to the overall compliance in Xellia
- Competitive compensation and benefit package
- Nordic-style culture dynamic teamwork good working atmosphere flexibility maintaining work-life balance
- Opportunity to learn and develop
- Stable international company background
- Multinational working environment
- Home office opportunity
Xellia Pharmaceuticals is a specialty pharmaceutical company and a global leader in providing anti-infective treatments and other critical care therapies for serious and often life-threatening conditions. Xellia has an extensive heritage in developing manufacturing and commercializing anti-infective products.
Headquartered in Copenhagen Denmark and owned by Novo Holdings A/S Xellia Pharmaceuticals has more than 1400 employees globally including state-of-the-art manufacturing sites in China Denmark and Hungary. Our strong market position is built on more than 120 years of pharmaceutical industry experience.
Further information about Xellia can be found at:
Connect with us onLinkedIn
Required Experience:
Unclear Seniority
Employment Type
Full-Time
