Octapharma is a privately-owned global company with over 7000 employees and is one of the leading players in the plasma industry. Octapharma has 5 production sites in Europe manufacturing human plasma derived products and recombinant protein products for treatments in immunotherapy, hematology and intensive care emergency medicine.
Corporate Quality Assurance Group is located in Stockholm and is linked to Octapharma Headquarters in Lachen Switzerland. Corporate QA has the overall responsibility for quality assurance and quality management of Octapharma´s quality systems globally.
Corporate QA Group in Stockholm is searching for a Senior Auditor to perform internal audits/inspections at the manufacturing and packaging sites within Europe and have an outstanding experience and competence of auditing aseptic manufacturing following the GMP regulations according to USA and EU. This is a permanent position and includes 40-50 travel days per year.
We are looking for a person with;
- several years of experience of auditing aseptic manufacturing in the pharmaceutical industry
- excellent knowledge of GMP, especially the FDA GMP rules and guidelines
- very good English skills
- university or college graduation
Responsibilities and tasks
Your main responsibilities and tasks are;
- planning and performing internal audits/ inspections of the manufacturing and packaging sites in Europe
- support and participate in FDA inspections at the manufacturing/packaging sites
- the subject matter expert in FDA GMP regulations and guidelines
- train the employees in FDA GMP and FDA-inspections
The ”ideal” candidate
It is of great value for us if you are;
- a self-starter with strong drive force and a good team player
- proactive and adaptable with strong work ethic
- enjoying working in a hectic working environment
- service-minded and enjoys meeting new people
If you have any questions please do not hesitate to contact recruitment consultant Ulrika Lewander, 070-841 92 21 or email@example.com. We look forward to receiving your application as soon as possible please. More information about the company is available at www.octapharma.com.