Deputy Rp

Current Opportunity

SERB Specialty Pharmaceuticals is a global specialty pharmaceutical group focused on prescription medicines which address rare and life-threatening diseases.

Following strategic acquisitions and targeted developments, SERB has succeeded in establishing a consistent drugs portfolio focused on niche specialty pharmaceuticals to ensure continuous availability of life-saving medicines and answer unmet medical needs.

Our commitment is to continue to offer essential drugs meeting Public health needs.

Main PURPOSE

In an international and fast-paced environment, the Quality Assurance and Regulatory Affairs Officer (QA/RA Officer) assists the QP/RA Manager of SERB SA with the execution of the quality/regulatory activities of SERB SA.

RESPONSABILITIES OF THE ROLE

The Quality Assurance and Regulatory Affairs Officer will assist in a wide variety of tasks relating to Quality Assurance:
Reviewing and compiling batch records, managine batch recalls

Ensuring compliance with marketing authorization

Qualification of suppliers and customers, drafting technical and subcontracting agreements

Maintaining the GMPD license and ISO certification

Managing any processes regarding medication and medical devices: non-conformities and complaints, distribution, withdrawals or returns, importation and exportation

Following-up on manufacturing operations, transfers and validations

Preparing management/quality review, drafting internal procedures, making all suggestions to improve the quality processes, corrective and preventive actions,

External audits and inspections

The Quality Assurance and Regulatory Affairs Officer will also be responsible for missions outside of Quality Assurance:
Assist in local aspects of Regulatory Affairs

Assist the Medical and Vigilance (Pharmaco-and Materiovigilance) Department in local aspects.

Assist in the management of medical/scientific information requests

Assist in the management of advertising, samples, compliance and ethics in relation to the RIP 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

REQUIRED SKILLS

Scientific background as a pharmacist of in biomedical sciences

At least 2 years of experience as a QA Officer in a pharmaceutical environment

Knowledge of CMC - Analytical, CMC - Production, GxP and ISO

Strong skills in pharmacovigilance and pharmaceutical regulations

**Personal skills**: accuracy, flexibility, teamwork

**Languages**: French, English and Dutch

LOCALISATION / Location

SERB S.A - 480 Avenue Louise, 1050 Brussels

Business trips expected

S erb Specialty 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.