Global System Auditor

vor 20 Stunden


Basel, Schweiz Bayer Vollzeit

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Global System Auditor (M/F/d)**

The Global System Auditor (M/F/d) plays a significant role in the ability of Bayer Pharma (BPH) and Bayer Consumer Health (BCH) to operate as a business by significantly influencing how all product development processes meet the expectations in terms of regulatory compliance and efficiency/productivity at a global level. This is achieved through the following activities:
**YOUR TASKS AND RESPONSIBILITIES**
- Manage audit team to ensure timely completion of Global System Audit activities by design and approval of detailed system audit plans for country and process audits in the area of R&D, Medical Affairs, Pharmacovigilance, and Commercial
- Develop relevant audit tools for collection of audit data, conduct and reporting of audits including identification of improvement areas, communication of system audit results within Bayer Pharma and Bayer Consumer Health as well as follow-up of audits including assessment of corrective/preventive actions
- Prepare, conduct, report, and follow-up of document audits (e.g. software validation documentation, submission documents, Pharmacovigilance relevant documentation)
- Provide interpretation and guidance for internal and external customers on R&D, Medical Affairs, Pharmacovigilance, and Commercial quality related regulations/guidelines (FDA, ICH, EU, GVP etc.) and company procedures and policies, proactively maintaining cognizance of current applicable standards
- Support the development and refinement of the Global Quality System by participating in SOP authorship or review teams
- Support of regulatory authority inspection activities as needed with focus on R&D, Medical Affairs, Pharmacovigilance, and Commercial topics

**WHO YOU ARE**
- University Degree (B.Sc or M.Sc) in a biomedical science or equivalent education
- Several years of working experience in the pharmaceutical industry
- Several years of experience of product development related activities and a proven record in Research & Development / Medical Affairs / Pharmacovigilance / Commercial auditing activities
- The position also requires up-to-date knowledge of modern information technologies and data management principles
- Knowledge of compliance of computerized systems and IT services (life cycle documentation, e.g. GxP determination, validation master plan, URS, risk assessment)
- Professionalism, strong stakeholder management, and ability to develop interdepartmental relationship
- Strong interpersonal and oral and written communication skills in order to effectively and independently conduct audits and communicate results
- Oral and written proficiency in the English language
- Willingness to travel up to 40% and must be able to work flexible hours, to accommodate European time zone differences

LI-GH

**YOUR APPLICATION**

**Location**:
Switzerland : Basel-City : Basel || United Kingdom : Berkshire : Reading

**Division**:
Pharmaceuticals

**Reference Code**:
565224



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