Quality Operations System specialist
takeda
Lessines, Belgium
1 dag geleden

Quality Operations System specialist

Primary Duties

  • Represent the quality function for Change Control :
  • Act as a Quality Representative to review, approve Change Request.
  • Participate to FMEA if requested
  • Redact shut down protocol and approve restart of activities.
  • Represent the quality function for deviations managment :
  • Act as Quality Representative to evaluate, investigate and approve deviations report.
  • Act as a quality link on the floor to support adequate quality systems deployment.
  • Support any quality decision in coordination with systems owner. Provide support and expertise in all quality related issues.
  • Perform GMP walkthroughs during routine operations to ensure the application of the cGxP’s, the compliance to the procedures, and all the aspects linked to the safety, the reliability and the consistency of the operations.
  • Participate to continuous improvement projects (Blue belt, DMAIC, ).
  • Data and trends analysis
  • Provide support for external audits.
  • Responsibilities

    Change Control / Projects / Shut down

    Deviations

    Continuous improvement

    Profile

  • Master degree in Science or Engineering or equivalent with experience
  • 4 - 5 years in pharmaceutical environment , good knowledge on technical equipement used in pharmaceutical industries.
  • Key skills

  • Good level of reading / writing English
  • Knowing the applicable regulation
  • Critical thinking and probem Solving
  • Organizational skills
  • Collaboration and Teamwork
  • Flexibility
  • Data and trends analysis
  • Complexity and problem solving

  • Pursuing deep fundamental root cause
  • Schematic and methodic structure
  • Understanding and systematic description of relevant and non-relevant
  • Other job requirements

  • Persistent curiosity
  • Asking why
  • Pursuing deep fundamental root cause
  • Schematic and methodic structure
  • Confident to communicate
  • 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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department.

    Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal.

    Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.

    Job ID SR0046686

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