Regional Audit Manager Manufacturing sites across Europe Central office in Budapest

Budapest - Hungary

Monthly Salary: Not Disclosed

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

Carbyne has been assigned to search & select an Audit Manager responsible for manufacturing entities in the EU. During the past decades our partner became one of the largest pharmaceutical companies and now reached another milestone: they decided to build an auditor team of 20 professionals who will audit the companys suppliers at European production sites. For this reason travel is necessary roughly 10-20% of the working time.You can live anywhere in the EU Ukraine or Serbia but relocation to Budapest is needed - Relocation Assistance Program is available. The role is hybrid with 3 home office days/week.

The team members will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality this role you will be the local quality contact between the Suppliers Global Quality Suppliers and Manufacturing sites to facilitate follow up of improvements and exchange of quality information.

Key responsibilities for this position:

Provide QA and technical support to Third Party Manufacturers (TPM) Contract Manufacturers and other stakeholders
Manage supplier audits ensuring alignment with cGMP and SOPs and assess supplier quality and CAPA compliance
Ensure compliance with Corporate and Divisional QA policies procedures standards specifications and relevant country regulations
Support specialized audits as needed and collaborate regionally on inspection preparedness
Address quality gaps in product design manufacturing and start-ups at TPMs ensuring overall product quality and safety
Track market and regulatory changes follow up on CAPAs and conduct on-site and remote audits of GxP and Health Regulated vendors

Basic requirements for applying for the position:

Masters or Ph.D. in Life Sciences
Minimum 2-3 years of relevant experience in the pharmaceutical industry
Experience in Compliance or Auditing
Possesses a deep understanding of cGMPs and the Code of Federal Regulations for drugs and biologics
Well-versed in Quality functions within the pharmaceutical sector
Fluent English knowledge

Should you be interested in the details of this vacancy feel free to submit your CV for this role our colleagues will contact you soon.

Required Experience:

Manager

Provide QA and technical support to Third Party Manufacturers (TPM) Contract Manufacturers and other stakeholders
Manage supplier audits ensuring alignment with cGMP and SOPs and assess supplier quality and CAPA compliance
Ensure compliance with Corporate and Divisional QA policies procedures standards specifications and relevant country regulations
Support specialized audits as needed and collaborate regionally on inspection preparedness
Address quality gaps in product design manufacturing and start-ups at TPMs ensuring overall product quality and safety
Track market and regulatory changes follow up on CAPAs and conduct on-site and remote audits of GxP and Health Regulated vendors

Basic requirements for applying for the position:

Masters or Ph.D. in Life Sciences
Minimum 2-3 years of relevant experience in the pharmaceutical industry
Experience in Compliance or Auditing
Possesses a deep understanding of cGMPs and the Code of Federal Regulations for drugs and biologics
Well-versed in Quality functions within the pharmaceutical sector
Fluent English knowledge

Should you be interested in the details of this vacancy feel free to submit your CV for this role our colleagues will contact you soon.

Required Experience:

Manager