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Quality Person in Plant – Germany – 7 Month Contract

Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Quality Person in Plant.

This is a Lead Quality role to support the drug substance manufacturing activities on site at Rentschler, Laupheim, Germany. The Quality lead will work alongside the Technical Lead to provide a cohesive team that will work in partnership with Rentschler to meet the milestones and timelines for commercial manufacture in compliance with the Regulatory filings and cGMP. The principal areas of responsibility will be to observe key steps in the DS manufacturing process, drive process improvements in batch file review, execute review in real time and to be the Quality lead on investigations at Rentschler. Hours of working will be in line with the manufacturing schedule key activities. General guidance is 08:00 to 16:00 or 09:00 to 17:00, Monday to Friday and this Quality Lead will be the primary out of hours contact for Quality should issues arise in manufacturing that require Quality input.

Responsibilities:

  • Be present in the manufacturing areas, as needed, to support routine PIP activities, or address specific issues should they occur.
  • Work with the Rentschler team and Dublin Disposition team on improving batch document review process and timelines.
  • Work with Rentschler, Technical Lead and Dublin CMO Quality oversight team to assist and support timely writing and closure of deviations.
  • Provide Quality support to the teams to assess/implement process improvements and address process issues.
  • Escalate significant issues to the Program Manager, Technical Lead and Quality Dublin.
  • Support Regulatory Authority questions/answers at Rentschler, including Quality input into new regulatory submissions.
  • Support inspections at Rentschler and support routine GMP inspections where questions arise relating to manufacture.
  • Provide support to Rentschler and the Training Manager for any training programs related to this project.
  • Work closely with the Program Manager, Technical Lead at Rentschler and the Quality teams at Dublin and provide weekly updates on progress.
  • Identify and work with Rentschler and Dublin team to map out and implement continuous process improvements to the Quality work flows. Support Value Stream Mapping improvements as identified by the cross functional team.
  • Attend and contribute to Business Review Meeting at Rentschler.

Education & Experience:

Essential:

  • Minimum Bachelor’s degree in Pharmacy, Chemistry, Biology or a related discipline prefrred.
  • Minimum 10years experience working in a Lead Quality role in the Biopharmaceutical industry.
  • Strong operations background to ensure value add and effective quality operations.
  • Experience leading, training and/or implementing root cause analysis and effective investigation practices.
  • Experience in interacting with health authorities including hosting/direct involvement with agency inspections.
  • Experience in a multinational organisation effectively navigating differing regional expectations and regulations.
  • English and German languages are essential.

Desired:

  • Track record of effective Quality leadership with Contract Manufacturing Organisations.

To be considered for this position please apply below.