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
Main Responsibilities & Accountabilities
Key activities
Pharmaco Vigilance roles and responsibilities
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Management of Internal and External Audits:
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Setting up an annual PV external and internal audit schedules.
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Ensuring Pharmacovigilance internal and external audits are adequately designed, carried out and managed.
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Being responsible for the execution of all PV related audits.
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Assessing the auditee’s CAPA plan for completeness, timeliness and accuracy.
2. SOP Management:
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Be responsible for keeping up to date all QA SOPs related to Pharmacovigilance auditing.
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Making sure the QA SOP’s related to Pharmacovigilance auditing are in line with current GVP standards.
3. Compliance:
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Ensuring compliance with regulatory requirements and quality standards in the field of Pharmacovigilance.
4.Communication and Collaboration:
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Collaborate with cross-functional teams, including PV, clinical development, regulatory affairs, and quality assurance
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Communicate regularly with stakeholders to provide updates on PV quality activities, findings, and recommendations
Education level
Bachelor’s degree in chemistry, Biology, Pharmacy or related
Work experience
Several years of experience in cGMP environment
Skills
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Certification as auditor
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Knowledge of audit methods and techniques, pharmaceutical laws and regulations and quality systems is required.
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Experience in training of internal / external auditors
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Strong analytical and problem-solving skills.
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Clear and effective communicator, both written and verbal.
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High attention to detail and strong decision-making abilities.
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Ability to work under pressure and manage multiple priorities.
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Strong collaboration and interpersonal skills to work within cross-functional teams.
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You have an excellent knowledge of English and French or Dutch; German is a plus.
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You are computer software literate (Windows, Word, Excel, Access);
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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!
Are you moving along? Then !
