QA Supplier Manager – Complaint Coordinator
The Quality Department within Sobi works with Quality Assurance, Quality Control, including QP-certification and distribution from active pharmaceutical ingredients to finished goods, both for commercial use and for use in clinical
trials. The quality unit consists of appr. 50 persons and QA Specialty Care (QA SC) is one of the sections.
QA SC, with 8 employees, is responsible for our contract manufactured products and for distribution of all Sobi’s contracted partner products. Totally around 40 products are included. The work is performed according to GMP and GDP.
This position includes:
- Being responsible for the handling of Product Complaints, including internal contacts with other departments as well as external contacts with contract manufacturers and distributors.
- Updating of SOPs related to Product Complaints including company training.
- Participate in Quality audits from authorities as well as from partners.
- Registration, assessment, investigation evaluation and approval of deviations.
- Act as contact person in specific quality issues related to the distribution of the commercial products.
- Maintain and develop the quality system.
- Other quality related activities as applicable.
- 2 years within Quality Assurance.
- University level education.
- Experience from working within the pharmaceutical industry or in a pharmacy.
- Fluent in Swedish and English – both written and spoken.
As a person you are independent, ambitious, clear and have a good attention to details. You don’t have any problems in handling several tasks at the same time, as well as quickly changing focus from one thing to another. You have a very good ability to co-operate with all kind of persons and are not afraid of learning new things. The ability to independently, in a positive and structural way, find information to solve new tasks, is highly valued.
The position is based in Hornsberg, Stockholm, Sweden and you report to Head of QA SC, Carina Carlsson.
If you are interested in applying for this position, please submit your CV and cover letter through the apply button on the left-hand side at latest 20 August, 2018.
Appointment of vacant positions at Sobi will take place with consideration of:
- Requirements of the role as it is currently framed as well as an assessment of how the post will develop;
- The competences, experience, personal qualities, and motivators of the candidates;
- The wish for Sobi to secure a well-functioning group with good team dynamics, able to be successful in an international, multi-cultural and cross-border business;
- A wish for all Sobi employees to embrace and align with the company’s values in their day-to-day operations.
Sobi™ is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primary focused on Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2016, Sobi had total revenues of SEK 5.2 billion (USD 608 M) and approximately 760 employees. The share (STO:SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.
Swedish Orphan Biovitrum AB