Senior Quality Assurance Officer, Deputy QP

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Senior Quality Assurance Officer, Deputy QP

Job Requisition ID: 32263

Department: QUALITY

Category: Quality

Location:

Brussels

Come save lives with us!

Serb Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 400 employees in 10 countries.

Our portfolio of 80+ rescue medicines makes a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority
• We act with integrity and accountability
• We work together as one team
• We look for better ways forward

Broad Overview

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).

As Quality Assurance Officer, your responsibilities will include:

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.
• 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.

To succeed in the position, you can benefit from your experience in :

• 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).
• 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.
• Decision-making
• 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.

Contract:

Full-time permanent contract, to be filled as soon as possible, located in Brussels (Avenue Louise)

Business trips expected

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.