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

Merck Group; Weiterstadt; Vor Ort; EUR 40.000 - 60.000; Teilzeit

Zusammenfassung

An established industry player is looking for a Quality Auditor to join their dynamic team. This role offers the opportunity to lead and coordinate quality audits in the pharmacovigilance area, ensuring compliance with international regulations. You will engage with various stakeholders, perform data analytics, and contribute to continuous improvement initiatives. The ideal candidate will have strong auditing experience, excellent communication skills, and a service-oriented mindset. If you thrive in a structured environment and are passionate about quality assurance, this is the perfect opportunity for you to make a significant impact in a collaborative setting.

Qualifikationen

• 3-5 years 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 findings.

Kenntnisse

Auditing experience in pharmacovigilance

Quality Assurance principles

Project management

Intercultural communication skills

Data analytics

Service-minded approach

Excellent oral and written communication in English

Knowledge of GVP, ICH, US FDA and EMA regulations

Tools

PowerBI

MS Office 365

Veeva Vault QMS

Jobbeschreibung

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

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 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 perform data analytics during the preparation phase, prepare meaningful, standardized audit plans, create audit reports, and present audit observations and follow up on those. Further, you will be taking over individual special projects to support the continuous improvement of the quality auditing function and to ensure audits are conducted consistently to high quality and in accordance with international and local Pharmacovigilance regulations and guidelines. Furthermore, you might support the Inspection Management Team in preparation and hosting of inspections and inspection outcome follow-up.

Who you are:

• Minimum 3-5 years auditing experience in pharmacovigilance quality management and/or systems
• Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance and auditing skills covering a broad range of areas with focus on pharmacovigilance and preferable additional GxP areas
• Working knowledge of GVP, ICH, US FDA and EMA regulations
• 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.
• Team player with very good intercultural and excellent communication skills; respectful interaction with auditees, independent, motivated, responsible approach to work
• User knowledge in PowerBI, MS Office 365, Veeva Vault QMS
• Excellent oral and written communication skills in English and ideally one other language (preferred Chinese or Spanish)
• Willingness to travel globally (up to 15% travel time)

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