Shire QA Operations Sr. Specialist in Lessines, Belgium

Function:

The purpose of this job is to act as quality expert for any quality/compliance related topics in relation with the operations

Quality operation within his area of responsibility:

  • Assure the correct deployment of the cGMP, Shire guidance within the quality operations department

  • Provide support and expertise in significant quality-related issues.

  • Supports if needed any process/facility/Equipment modification by participating to the quality requirements definition for related projects

  • Support any quality decision on the floor in coordination with Manufacturing. Provide support and expertise in all quality-related issues

Continuous improvement:

  • Develop continuous improvement projects (DMAIC, Problem Solving, …) in the framework of quality operations department.

  • Lead and or participate to continuous improvement initiative

  • Support all global initiatives related to quality related topics for his area of responsibility

  • Provide expertise during the revision of Global procedures and guidances

  • Developp quality strategy for sytem

Quality system within his area of responsibility:

  • Act as quality representative in the evaluation, the implementation and the approval of change control

  • Act as Quality Representative in the evaluation (risk evaluation, lots potentially impacted and to be held from release), the investigation (including quality impact) and the approval of deviation Reports

Compliance

  • Participates in external inspections.

  • Provide support if necessary to the RA group by providing required data for submission files

Profile:

  • Master degree in Engineering or Science (Biology, Pharmacy, Chemistry)

  • 5-10 years in pharmaceutical industry with manufacturing environment

  • Technical writing skills

  • Good communication skills

  • Strength organization skills

  • Autonomy

  • Fluent in English

  • Good overview of the differents quality systems

  • Continous improvement mindset: green belt certified is a plus

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.