Senior Quality Assurance Officer

Senior Quality Assurance Officer / Deputy Qualified Person

Scope: SERB SA – Belgium & International / activities GMDP / ISO*

Rôle / role

The Senior Quality Assurance Officer / Deputy Qualified Person (Sr QAO/QP) assists the Quality Director/QP of SERB SA as a senior member of the local quality team, with the execution of the company's quality management processes. The principle focus of the role is maintaining GMDP compliant supply chains, supporting control of the company's quality management system (QMS), batch certification (GMP release) and administrative (GDP) releases as a Responsible Person (RP).

The job holder is expected to be a QP and RP recognized by the Belgian authorities.

*ISO 13485 / Medical Device Directive 93/42/EEC / MDR experience is preferred but not essential.

SITUATION DANS LA STRUCTURE - LIEN HIERARCHIQUE / N+1

Snr QA Officer / Deputy QP

Quality Director / QP

DELGATION DANS LA STRUCTURE / DELEGATION OF AUTHORITY

• In the absence of the Quality Director/QP, delegation of authority will be assigned to the deputy QP as both QP and RP.
• The job holder will be the administrative deputy for the Quality Director/QP in their absence, taking over management of the local quality department, including the team members.

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.

Compétences techniques / Technical skills

• Detailed, current knowledge of GMDP pharmaceuticals regulations.
• CMC - Analytical
• CMC – Production
• PV
• Knowledge of medical device regulations : MDD / MDR / MDSAP / ISO 13485 (preferred not essential).
  

Compétences Comportementales / Soft skills

• Decision-making
• Independence
• Accuracy
• Flexibility
• Teamwork
• Languages : French and English, if possible Dutch
  

Formation & experience / Education and experiences

• Qualified Person recognized by the Belgian authorities.
• Responsible Person recognized by the Belgian authorities.

LOCALISATION / Location

SERB – 480 avenue Louise, 1050 Bruxelles

Hybrid working potential

Regular business travel is required (up to 10%)

SOLLICITEREN