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Data Integrity Project Specialist

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Takeda Neuchâtel

Site de Production Biotech | Biotech Manufacturing Site

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Data Integrity Project Specialist

Takeda Neuchâtel

Site de Production Biotech | Biotech Manufacturing Site

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.


Takeda’s Neuchatel Manufacturing plant is looking for two highly motivated Project Specialists for a period of 12 months to work on project focused on Data Integrity.

Your mission

Within the Manufacturing support department, the purpose of this role to provide the technical expertise needed to participate in a Data Integrity project within the manufacturing process and to act as a catalyst for continuous improvement.

Essential Duties & Responsibilities

  • Support the Data Integrity project for the whole manufacturing plant
    • Participate in the meetings related to this project
    • Follow-up on the assigned actions related to the scope of this project
  • Lead, perform and review risk/gap assessments related to the manufacturing equipment and associated data.
  • Work on actions linked to production-related gap and risk assessment: participate in change control and documentation updates activities
  • Work on actions linked to gap assessment and risk assessment (production related)
  • Perform quality and manufacturing technical aspect reviews for the equipment

    Required Skills

  • Demonstrated experience in manufacturing and/or data integrity projects
  • Confirmed experience with automated systems used in biotechnology industry
  • Expertise in Quality/Compliance within an FDA regulated/GMP manufacturing field required
  • Ability to provide solutions to satisfy business objectives and cost implications within timelines
  • Structured systems thinking with good technical understanding of operations
  • Ability to think and act cross-functionally, interacting with experts, SME’s, engineers etc.
  • Project management training or experience is an asset (from URS to implementation)

    Personal qualities

  • Interpersonal skills, self-motivated, capable of analyzing and solving problems
  • Great team player prepared to work in and embrace a team-based culture and more specifically within the manufacturing teams directly on the production floor
  • Excellent oral and written skills in English and French
  • Ability to describe processes and qualifications and to translate them into clear, precise reports

    Working Environment

  • While this is a day-time job, must be able to work on occasions in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

Address

Route de Pierre-à-Bot 111 2000 Neuchâtel

Website https://www.takeda.com/fr-fr

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