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Senior Quality Assurance Officer

SERB NV in ELSENE
time Online sinds 3 juli 2024 - Vaste jobs

QUALITY

  • Deputy Qualified Person for batch certification according to the Directive 2001/83/EC on medicinal products for human use and the guidelines on Good Manufacturing Practices (GMP) (Volume 4).
  • Deputy RP for Good Distribution Practices (GDP) according to the Directive 2001/83/EC on medicinal products for human use and the guidelines of 5 November 2013 on GDP for medicinal products for human use.
  • Review, compilation and release of batch records for administrative (GDP) release or batch certification (GMP), as appropriate.
  • Completion of register of released batches (and samples).
  • Quality oversight of contracted out manufacturing operations.
  • Assist in the management of the distribution including import and export of medicines.
  • Review and approval of transfer and validations of manufacturing and testing operations.
  • Lead the drafting/approval of product specifications.
  • Assist in the preparation of the quality management review at group level.
  • Proactively participate as a senior quality team member in the company's QMS processes, including but not limited to deviation/investigation management, corrective and preventative actions, change control and complaints management.
  • Ensure compliance with marketing authorisations / CE mark (regulatory dossier).
  • Assist in the management/coordination of all activities related to a batch recall
  • Proactively participate in the management of artwork and marketing/promotional materials.
  • Assist in the management of stability studies and Product Quality Review.
  • Ensure the compliant implementation of serialization.
  • Audits & Inspections:
    • Participate in the preparation and risk assessments for the internal and external audit schedules.
    • Plan and lead external audits.
    • Participate in inspections by competent authorities as a subject matter expert.
    • Participate in self-inspections / internal audits.

Other

  • Assist in local aspects of Regulatory Affairs
  • Assist the Medical and Vigilance (Pharmaco and Materiovigilance) department to ensure compliance at SERB SA.
  • Assist in the management of medical / scientific information requests.
  • Assist in the management of advertising, samples, compliance in relation to the RP function for Belgium, Luxembourg and the Netherlands.
  • Assist in the management of prices and refunds for Belgium, Luxembourg and the Netherlands.
  • Monitors the regulations in force and their evolution.
  • Assist for budget management.

Team management

  • This role does not have reporting staff, but is expected to work within the matrix of the local (SERB SA) and wider (SERB Pharmaceuticals) quality teams as a senior member.This will include providing support, training and mentoring to the more junior members of the team as required for team development and efficient and compliant performance of the team.