Quality System Manager till Sobi
Swedish Orphan Biovitrum AB (publ) / Biomedicinjobb / Stockholm
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hela Sverige Do you want to take SOBI's QMS system to the next level? We are looking for a driven and innovative Quality Assurance professional to join Sobi's Quality Management System group within Global Quality Systems and Support. In this role you will be one of the key resources driving how Sobi works with continuous improvements of the global quality processes. You will focus primarily on being the global GxP process owner, with all what this entails, for the quality systems; Deviation, CAPA, Change Management and Validation as well as quality reporting.
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. The position is full time and you will be employed by Sobi, based in HQ in Stockholm. Key Responsibilities:
Lead and participate in continuous improvement of the Sobi Quality Management Systems, implementation of cGXP requirements and QMS projects to strengthen the way Sobi works
Be the Process Owner of the Deviation, CAPA, Change Management and Validation
Help build 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
Coordinate and support the Quality reporting of KPIs, coordination and documentation of Quality Management Review (QMR) and Quality Activity Plans (QAPs).
Support and work as back-up for GQSS team members, primarily focusing on regulatory surveillance and risk management
Creating training material and train others in QMS related trainings when needed for processes owned by role as well as for e.g. GXP introduction trainings for new employees within the company
Participate and support during regulatory inspections and audits of Sobi
Qualifications:
High level education (university degree or similar) within relevant area such as biotech, pharmacy, chemistry etc.
Relevant experience from Pharmaceutical, biotech or life science company within Quality
Experience from implementation and/or development of quality systems and processes, preferably in an environment with GXP scope
Technical understanding and ability to promote process improvement in quality systems
Project management experience
GMP related requirements
Experience of computerized quality system and application usage
Quality process improvement methodology, Lean/Six Sigma
Fluently spoken and written English and Swedish
Personal attributes:
We are looking for a person with great understanding of the Quality Management System processes, who has the ability to actively search for, retrieve and draw conclusions from found information. You are driven and motivated to meet the regulatory requirements, and you have the ability to 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.
Location:
The position will be based in Stockholm.
Reporting to:
Director Global Quality System Manager.
For more information:
If you are interested in applying for this position, please submit your CV and cover letter through our web page
www.sobi.com Swedish Orphan Biovitrum AB
www.sobi.comPubliceringsdatum2019-10-21Så ansöker duSista dag att ansöka är 2019-11-20
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
Övrig information om företaget/organisationen Offentliga upphandlingar där Swedish Orphan Biovitrum AB (publ) varit leverantör Jobbnummer 4868429
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