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Senior Quality Assurance Officer

SERB NV in ELSENE
time Online sinds 19 juni 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.

Senior Quality Assurance Officer

SERB NV in ELSENE
time Online sinds 19 juni 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.