Auditor QA Pharmaco Vigilance | Brussel | 4 days/week

Prothya Biosolutions (operating under Accord Plasma B.V. / Intas Pharmaceuticals); Brussel Hoofdstad; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Group health insurance

Meal vouchers

Eco-cheques

Flex Reward Plan

Holiday system

Homeworking after onboarding

Résumé du poste

Prothya Biosolutions Belgium is seeking an Auditor QA Pharmaco Vigilance to manage and execute the PV audit program in Brussels, four days a week. You will coordinate internal and external audits, ensure alignment with GVP standards and regulatory requirements, and report findings to the Senior Manager QA Systems Global.

The ideal candidate holds a degree in chemistry, biology, pharmacy or related field, several years in a cGMP environment, and certifications as an auditor.

Qualifications

• Bachelor’s degree in chemistry, biology, pharmacy or related.
• Several years of experience in a cGMP environment.
• Certification as auditor and knowledge of audit methods.
• Experience in training internal/external auditors.
• Strong communication in English and Dutch or French.

Responsabilités

• Management of internal and external Pharmacovigilance audits, both PV and external audits.
• Set up annual PV audit schedules and ensure audits are designed, carried out and managed.
• Assess auditee CAPA plans for completeness, timeliness and accuracy.
• Maintain up-to-date QA SOPs related to PV auditing and ensure alignment with GVP standards.
• Communicate findings and recommendations to cross-functional teams.

Connaissances

Auditing

Analytical skills

Problem solving

Communication

Cross-functional teamwork

English proficiency

Dutch or French

Formation

Bachelor's degree in chemistry

Biology or Pharmacy

Outils

Windows

Word

Excel

Access

Description du poste

Auditor QA Pharmaco Vigilance | Brussel | 4 days/week

Job: QA/Pharmaco Vigilance Auditor | Brussels (4 days/week)

Reports to:Sr. Manager QA Systems Global

Purpose of the job

Purpose of this job is management and execution of Pharmacovigilance (PV) external and internal audit program at Prothya Biosolutions

Key activities

Pharmaco Vigilance rolesand responsibilities

• Management of Internal and External Audits:
• Setting up an annual PV external and internal audit schedules.
• Ensuring Pharmacovigilance internal and external audits are adequately designed, carried out and managed.
• Being responsible for the execution of all PV related audits.
• Assessing the auditee’s CAPA plan for completeness, timeliness and accuracy.

2. SOP Management:

• Be responsible for keeping up to date all QA SOPs related to Pharmacovigilance auditing.
• Making sure the QA SOP’s related to Pharmacovigilance auditing are in line with current GVP standards.

3. Compliance:

• Ensuring compliance with regulatory requirements and quality standards in the field of Pharmacovigilance.

4.Communication and Collaboration:

• Collaborate with cross-functional teams, including PV, clinical development, regulatory affairs, and quality assurance
• Communicate regularly with stakeholders to provide updates on PV quality activities, findings, and recommendations

Bachelor’s degree in chemistry, Biology, Pharmacy or related

Several years of experience in cGMP environment

Skills

• Certification as auditor
• Knowledge of audit methods and techniques, pharmaceutical laws and regulations and quality systems is required.
• Experience in training of internal / external auditors
• Strong analytical and problem-solving skills.
• Clear and effective communicator, both written and verbal.
• High attention to detail and strong decision-making abilities.
• Ability to work under pressure and manage multiple priorities.
• Strong collaboration and interpersonal skills to work within cross-functional teams.
• You have an excellent knowledge of English and French or Dutch; German is a plus.
• You are computer software literate (Windows, Word, Excel, Access);
• Flexible and able to travel to Prothya Amsterdam or Supplyers depending on the business needs.

Our Company

Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!

We offer

Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.

In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.

We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).

Furthermore, we value mutual respect and diversity is our strength.

At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!