Quality Manager

hace 2 semanas


Barcelona, Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completo
Job Title: QMS Manager

Centrient Pharmaceuticals Netherlands is seeking a highly skilled QMS Manager to join its Global Quality team. As a QMS Manager, you will play a critical role in defining and implementing a clear and robust document hierarchy for global documents, standardizing and harmonizing global quality procedures and policies within the global quality organization.

Main Responsibilities:
  • Define and implement a clear document hierarchy for global procedures and policies.
  • Design and (re-)draft global quality procedures that are aligned to the current regulatory expectations.
  • Revise or revisit Quality manual and other GxP documents, standardize, harmonize and/or simplify as required.
  • Ensure that the procedures are current and suited to evolving GMP and regulatory requirements.
  • Timely revision and updating of global documents.
  • Support development & continuous improvement of Centrient Quality Systems.
  • Support leadership teams in regulatory inspections and customer audits.
  • Support effective training of global procedures across Centrient Sites.
  • Lead and/or support GxP quality audits and monitor corporate annual audit plan.
Requirements:
  • Bachelor or post graduate degree in Science, Pharmacy or related field of study.
  • +8 - 10 years of industry experience.
  • Advanced level of English language (written and spoken).
  • In depth knowledge of cGMP and regulatory requirements.
  • Proven skills in technical writing.
  • Prior experience in similar roles with good organization skills.
  • International exposure and ability to manage cultural differences.
  • Ability to obtain commitment on required actions.
  • Resourceful in finding and keeping abreast of the latest developments in the cGMP and regulatory environment.
Benefits:

We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals. The organization is very flat. You have a lot of freedom and responsibility in an open, direct, and informal atmosphere.



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