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Compliance Coordinator

Santa Rufina, Italy, Rieti, Italy

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Inclusive

    Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Compliance Coordinator

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Job ID SR0032721 Date posted 04/19/2019 Location Santa Rufina, Italy; Rieti, Italy

A. Compliance Documentation

Act as  tracking coordinator for Rieti Plant collecting, archiving and distributing License Information (LI) and Post market Commitments (PMC) up to the  implementation of needed actions.  

Assure the  preparation of documentation (such as GMP certificate and Manufacturing License)  requested for Variations/Submission/Site Accreditation in foreign countries.

Support the revision of Site Master File.

 B. Project related  Activities

Support the preparation and the revision of documents related to Rieti Projects such as Risk Assessment, SOPs and Technical Document.

Support the drafting of Common Technical Document _ Module 3 (Quality) sections (3.2.S, 3.2.P, 3.2.A) as per company plans and needs.

Support the activities tracking as per project needs

 C. Regulatory Inspection, Corporate Audit,  Inspection Readiness Assessment

Support regular GMP or Pre-Approval Inspections conducted by Authorities or Audits  by third parts as needed. Support Internal audit (Corporate/IRA) as needed.

Education & Experience Requirements

Essential: Degree in Chemistry / Biochemistry / Biology or equivalent scientific disciplines. Good written and spoken English language.

Desired: 1- 3- years of experience in Pharmaceutical Quality System and cGMP. Experience on Project management and/or Project management software/tools. Communication and relationship skills. Team work oriented.

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 SR0032721

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