QC Instrument qualification specialist (Metrologist)

About tje job

The Equipment Qualification Group is responsible for managing the entire lifecycle of laboratory instruments from procurement to decommissioning. We ensure the GMP compliance of the equipment fleet organize and document service activities qualifications and calibrations and perform in-house qualification of various instruments (e.g. thermostats refrigerators stability chambers chromatographs). Our goal is the continuous improvement and internalization of qualification activities thereby supporting the laboratories efficient and reliable operation.

Responsibilities

• Participation related to regulatory inspections and corporate audits including audit/inspection readiness communications response handling
• Participation in local and global projects
• Responsible for performing internal qualifications and calibrations (Warehouse Refrigerators Autoclaves HPLC).
• Responsible for new purchasings and purchasing of accessories equipment needed for QC laboratory. Participation in installation and qualification of new equipment
• Responsible for executing and/or coordinating the qualification processes (IQ/OQ/PQ) of the equipment with the external suppliers and with the other departments within Xellia.
• Support and troubleshoot the daily operations of laboratory equipment
• Keeping up-to-date the instrument files archiving
• Daily use of different systems/softwares used in QC as LIMS TrackWise Empower EMS etc.
• Responsible for GMP documentation
• Responsible for instrument (analytical and microbiological) calibration/qualification and maintenance program in QC laboratories creating and follow-up of annual plan
• Foster continuous improvement and develop solutions to address issues improve processes and quality metrics.
• Escalate issues or potential Quality events in a timely manner.
• Maintain and continuously develop knowledge of global GxP regulations and guidelines.
• Satisfactorily completes all cGMP corporate and safety training in conformance with Xellia requirements.

What we expect

• Minimum High School Diploma with metrology experience or BSc in a relevant scientific field with at least 2 years of cGMP experience
• Minimum 2 years of experience in a routine QC laboratory or Metrology environment
• Experience in metrology including calibrations and equipment qualifications
• Strong analytical and problem-solving skills
• Good documentation and record-keeping abilities
• Working knowledge of standard computer applications (Word Excel database systems)
• Excellent written and verbal communication skills
• Strong teamwork and adaptability
• Takes accountability and works independently to meet deadlines
• Makes informed and timely decisions with minimal supervision
• Remains flexible and effective in changing environments
• Applies technical knowledge to deliver high-quality results

What we offer

• 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 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 seven 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 aboutXellia can be found at:
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