QA Supplier Manager, Complaint Coordinator, Temporary Position
Swedish Orphan Biovitrum AB (publ) / Biomedicinjobb / Stockholm
Observera att sista ansökningsdag har passerat.
Visa alla biomedicinjobb i Stockholm,
Solna,
Lidingö,
Sundbyberg,
Danderyd eller i
hela Sverige Visa alla jobb hos Swedish Orphan Biovitrum AB (publ) i Stockholm,
Solna eller i
hela Sverige Do you want to manage and help develop SOBI 's Complaint process for the future?
Sobi is searching for a driven and innovative Quality Assurance professional to join Sobi's Global Quality Management System group within Global Quality. In this role you will be responsible for coordinating the compliant handling as well as participate in a project to improve the complaint process and implement an electronic solution enabling a more efficient and scalable complaint process for Sobi going forward.
As a part of the global Quality Management Systems (QMS) team you will support the fast growing global Sobi organization and help ensure that the Sobi QMS is compliant and meets the requirements set by regulatory authorities. This is a temporary position around 1 year, full time and you will be employed by Sobi, based in HQ in Stockholm.
The work is performed according to GxP, and experience within GMP/GDP required for position.
Responsibilities:
Coordination and handling of Product Complaints including internal contacts with other departments and external contacts with contract manufacturers and distributors, registration, initial assessment and support with investigation of complaints.
As responsible for complaint management, maintain and update related SOPs, monitor the process and report KPIs.
Creating training material and train others in complaints as well as ensure that the company training for complaints is up to date and distributed.
Participate and support during regulatory inspections and audits of Sobi
Help maintain, develop and monitor the effectiveness and improve the processes together with other functions, including identify and implementing relevant supporting tools to reach the next level QMS, especially related to quality processes owned by the department
Other quality related activities as applicable.
Qualifications
High level education (university degree or similar) within relevant area such as biotech, pharmacy, chemistry etc.
2 years within Quality Assurance.
Relevant experience from Pharmaceutical, biotech company or pharmacy within Quality
Experience from implementation and/or development of quality systems and processes in an environment with GMP/GDP scope
Experience of computerized quality system and application usage
Fluently spoken and written English and Swedish
Your profile
We are looking for a person with good understanding of the Quality Management System processes within the pharmaceutical industry, who can actively search for, retrieve and draw conclusions from found information.
You are driven and motivated to meet the regulatory requirements, and you can do so in an independent manner. Furthermore, you have great collaborative- and pedagogic skills, which help you educate and promote the process development within your given areas in an effective manner.
Personal attributes:
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.
Application
If you are interested in applying for this position, please don't hesitate to submit your CV and cover letter through our web page
www.sobi.com as soon as possible.
Interviews and candidate selection are done continuously!
Publiceringsdatum2019-11-11Så ansöker duSista dag att ansöka är 2019-12-11
Klicka på denna länk för att göra din ansökanAdressSwedish Orphan Biovitrum AB (Publ)
Tomtebodavägen 23 A
17165 Solna
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Swedish Orphan Biovitrum AB (Publ) (org.nr 556038-9321)
Tomtebodavägen 23 A (
visa karta)
171 65 SOLNA
Arbetsplats Sobi
Jobbnummer 4950038
Observera att sista ansökningsdag har passerat.