On behalf of a small but leading biotechnology company with services to support all stages of biologics development, I am currently looking for a Senior QA Auditor. In this role you will be part small, but growing international team and will be providing QA support to the European operations. The company will also support your career development.
Your tasks as a Senior QA Auditor are the following:
Lead and conduct routine audits and inspections (in-phase, process, facility, vendor and computer/equipment systems)
Write and issue audit reports and review responses to audit findings for correctness and completeness
You will write QA SOPs and provide regulatory input for other department SOPs and company policies
Assist in educating, guiding and influencing management and staff on best quality and compliance policies
Maintain documentation and status of auditing activities
Support regulatory and sponsor audits
Degree in biology, chemistry, or other scientific or related field with a minimum of five years of experience in pharmaceutical / biotechnology / CRO preclinical / clinical quality assurance operations
Experience hosting regulatory/sponsor audits
Solid understanding and up to date knowledge of FDA and EPA GLP regulations, OECD Principles of Good Laboratory Practice, FDA GMP regulations and industry standards as they apply to the life sciences and pharmaceutical industries
Ability to work in a fast paced environment where multiple projects are in process and must be completed in a timely manner under minimal supervision
Proficient use of computer and Microsoft applications
Fluency in English is a must and fluency in German is desired
Excellent oral and written communication skills with attention to detail
Should you be interested in this opportunity then do not hesitate to send me your CV to . You can also reach me on for more information.
Please note that our client and not able to sponsor visas, therefore we are only able to consider applications from candidates who are citizens of the European Union or have the legal right to work in Germany.