The Quality Auditor/officer conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOP's and GMP's and worldwide regulations.
- Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
- In addition, the Auditor communicates and resolves audit comments with client areas.
- Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards.
- Issue reports summarizing deficiencies and work with areas to execute remedial action.
- Notify appropriate management of inspection result.
- Position will receive direction and support.
- Bachelor's or Master's Degree in Science or Engineering with at least 5 years of experience in the pharmaceutical industry within the Quality Operations Department
- Minimum of 3 years of experience with exposure to investigations execution in an FDA related environment with technical expertise and strong Quality Systems background
- Knowledgeable with cGMP's applied to drug product/drug substance and manufacturing is required
- Technical knowledge in manufacturing processes and analytical testing techniques
- Effective planning skills
- Excellent interpersonal and communication (oral and written) skills, in English
- Technical Writing
- Root Cause Analysis
- Failure Mode & Effect Analysis (FMEA)
- CAPA establishment and Lean Six Sigma
- Experience with documentation systems and SAP is a preference
- A young and dynamic company with a feel good culture, an a great openness and a no-nonsense approach
- Real investment in people through education and fun events
- A competence development model focused on your personal ambitions
- An attractive salary package