Quality Assurance Associate
Takara Bio Europe AB / Biologjobb / Göteborg
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hela Sverige Primary Duties & Responsibilities
• Maintainence of Quality System processes and procedures (i.e., document management, risk assessment, validation, change control, deviations, corrective action/preventative action, training, quality control, and specifications etc.).
• Development of Quality System processes and procedures, i.e. write and review SOPs and other quality related documents in the Company's Quality System.
• Review of batch documentation.
• Review, approval and closure of deviations ensuring adequacy of investigations, root cause and appropriate CAPAs.
• Review, approval and closure of Change documentation ensuring relevant Quality requirements are met.
• Issue Change documentation and Deviations for items directly related to the Quality function.
• Participate in validation, audits and training as necessary.
• As needed act as facilitator for Quality related Risk Assessments.
General Duties & Responsibilities
• Exhibit general knowledge of professional ethics, laws and regulations.
• Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP) and ISO 9001/2015.
• Relies on instructions and pre-established guidelines to perform the job.
• Normally receives no instructions for routine work, general instructions on new assignments.
• Other required duties may be assigned.
The Quality function provides assurance that we meet safety, quality, identity and purity requirements of our products and services. The QA Associate plays an important role to support the business in delivering and improving products/services and to meet regulatory requirements. As a member of the Quality team, the QA Associate ensures that work is consistent with the overall strategic direction of the Quality department and the organization and accomplished through close collaboration with colleagues or external consultants.
Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB is located in state-of-the-art facilities in Göteborg, Sweden and has a newly-established GMP laboratory for production of pluripotent stem cell lines.
Varaktighet, arbetstid
60%-80%
Publiceringsdatum2018-02-23Så ansöker duSista dag att ansöka är 2018-03-25
Ange följande referens när du ansöker: Quality Assurance Associate
KontaktHelena Choukair
helena_choukair@takarabio.com 031-758 0921
Dan Lundin
dan_lundin@takarabio.com 031-758 0960
FöretagTAKARA BIO EUROPE AB
AdressTAKARA BIO EUROPE AB
ARVID WALLGRENS BACKE 20
41346 GÖTEBORG
KontorsadressARVID WALLGRENS BACKE 20
Jobbnummer 3984413
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