Quality Auditor for Good Pharmacovigilance Practices (all genders) - part-time possible

Merck Group; Deutschland; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

An established industry player is looking for motivated individuals to join their quality auditing team. In this dynamic role, you will lead and participate in various quality audits, ensuring compliance with international pharmacovigilance regulations. Your expertise in data analytics will be crucial in preparing audit plans and reports, while your strong communication skills will facilitate respectful interactions with stakeholders. This position offers the opportunity to contribute to continuous improvement initiatives and engage in special projects. If you are a structured, service-minded professional with a passion for quality assurance, this is the perfect opportunity for you.

Qualifikationen

• 3-5 years of auditing experience in pharmacovigilance quality management.
• Strong knowledge of GVP, ICH, US FDA, and EMA regulations.

Aufgaben

• Lead and coordinate quality audits in pharmacovigilance globally.
• Prepare audit plans, reports, and present observations.

Kenntnisse

Auditing experience in pharmacovigilance quality management

Quality Assurance principles

Project management skills

Communication skills

Intercultural skills

Data analytics

Service-minded approach

Fluency in English and one other language

Structured working style

Tools

PowerBI

MS Office 365

Veeva Vault QMS

Jobbeschreibung

Your role: We're seeking highly motivated and self-starting individuals to join our diverse and very engaged quality auditing team! We offer a quality auditing function, with good visibility into our Research & Development function and close interaction with various stakeholders. In this role, you will lead, coordinate, and participate in the organization and execution of quality audits of different types (on-site or remote subsidiary/affiliate audits, vendor audits providing GVP services, process audits, and business partner audits) in the pharmacovigilance area globally. You will perform data analytics during the preparation phase, prepare meaningful, standardized audit plans, create audit reports, and present audit observations while following up on those. Further, you will take over individual special projects to support the continuous improvement of the quality auditing function and ensure audits are conducted consistently to high quality in accordance with international and local Pharmacovigilance regulations and guidelines. Additionally, you may support the Inspection Management Team in preparation and hosting of inspections and inspection outcome follow-up.

Who you are:

1. Minimum 3-5 years auditing experience in pharmacovigilance quality management and/or systems
2. Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance and auditing skills covering a broad range of areas with a focus on pharmacovigilance and preferable additional GxP areas
3. Working knowledge of GVP, ICH, US FDA, and EMA regulations
4. Strong ability to work in a structured way: good planning, project management, and organization skills, track record of meeting milestone deliveries under tight deadlines, and having a service-minded but goal-oriented mindset.
5. Team player with very good intercultural and excellent communication skills; respectful interaction with auditees, independent, motivated, responsible approach to work
6. User knowledge in PowerBI, MS Office 365, Veeva Vault QMS
7. Excellent oral and written communication skills in English and ideally one other language (preferred Chinese or Spanish)
8. Willingness to travel globally (up to 15% travel time)

Department: HC-RD-RFAC Quality Auditing
Job evaluation: AT-level 3 (Expert)