Global Quality Auditor
Global Quality Auditor
The mission of this team is to define the Global Quality Audit policy and to coordinate its implementation across the business and to provide an accurate, independent assessment of sites, Development Centres, country offices, CDMOs and Suppliers for compliance with our partner’s Quality Policy / requirements and applicable regulations through audit and inspection support activities.
Why should you join:
- Competitive wages
- Flexible Home Office opportunities- (60%)
- Yearly bonus
- Cafeteria
- Yearly medical check-up
- Excellent working conditions
- Great atmosphere with an international professional team
- Opportunity to use your language skills
- Well-structured and employee friendly On-boarding
- Support of career aspirations and personal development
What will you do:
- Conduct GxP audits (Sites, Development Centres, country offices, CDMOs and Suppliers of Active pharmaceutical ingredients, raw Materials, packaging components) mainly in Europe (significant part of the time dedicated to international travels)
- Support the worldwide auditor’s team as necessary.
- Prepare audits and issue audit reports in a timely manner.
- Conduct Global transversal assessment audits.
- Approve / Manage audit CAPA to agreed timelines.
- Keep up to date with current and forthcoming regulatory authority requirements. Effectively evaluates compliance with these requirements at our partner’s entities and third parties and identifies ways for these entities to increase their level of compliance.
- Together with the Audit lead & Inspection coordinator, support the preparation and follow-up of Regulatory Inspections for GxP activities in the Europe region as required.
- Support the training and certification of the new Global Quality auditors in the region.
- Provide expertise on GxP requirements to the entities in the Europe region. Support the local auditors when specific expertise is necessary.
- Organize communications and Training for the Quality network in the Europe region as necessary.
Join if you have:
- Experience: 10+ years working experience in Quality management and auditing in Pharmaceutical Industry.
- Technical skills:
- Good knowledge of GXP regulations and pharmaceuticals standards for a wide range of products (CHC Drug Products, Nutraceuticals, Cosmetics, Medical Devices)
- Be a qualified auditor, minimum experience of 5 years in a GMP/GDP environment.
- Ability to make accurate quality evaluations based on multiple data coming from different sources
- Soft skills: Organization and communication skills, networking capability, leadership and assertiveness skills.
- Education: Pharmacist or advanced degree (e.g., Master, PhD or equivalent) in life sciences or related fields
- Languages: English spoken and written compulsory. Speaking French is an asset.
Location: Budapest XIII. District
