Takara Bio Europe AB, formerly Cellartis AB, 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. For more information, visit our website: www.takarabio.com
General Duties & Responsibilities
- Exhibit general knowledge of professional ethics, laws and regulations.
- Maintains broad knowledge of Quality principles and theories including Good Manufacturing Practice (GMP) and ISO 9001/2015.
- Normally receives assignments in the form of objectives and determines how to use resources to meet deadlines.
- Provides guidance to colleagues within the extent of established company Quality policies and procedures.
- Recommends changes to Quality policies and procedures.
- Other required duties may be assigned.
Primary Duties & Responsibilities
- Lead and manage a small QA/QC team, where responsibilities include development of personnel, recruitment, economical follow up and day to day work planning.
- Maintenance and Development of Quality System processes and procedures (i.e., document management, risk assessment, validation, change control, deviations, corrective action/preventative action, training, quality control, specifications etc.)
- Review and assessment of batch documentation and QC documentation.
- Issue, review and approve QC batch related documentation and environmental control documentation.
- Issue, review and approve Change documentation and Deviations related to the Quality function.
- Issue, review and approve qualification and validation documentation for QC equipment and systems.
- Review and approval of qualification and validation documentation for systems, equipment, facilities, manufacturing or testing methods.
- Review, approval and closure of deviations and non-conformances ensuring adequacy of investigations, root cause and appropriate CAPAs.
- Review, approval and closure of Change documentation ensuring relevant Quality requirements are met.
- Plan, perform and report internal and external audits.
- Take part in regulatory inspections and customer audits.
- Facilitate or take part in Quality related Risk Assessments.
- Train employees in GMP, QC, ISO 9001 and other relevant areas.
- Minimum MSc in Pharmacy, Cell Biology, Microbiology or related field.
- Minimum of 5 years of relevant experience preferably in the biotech/biologics area
- Experience of work with ATMP and/or stem cells is an advantage.
- Proven experience of people’s management from a line function or project management role.
Welcome with your application no later than July 27, 2019. We apply continuous evaluation of applicants, therefore this position can be filled before due date.
For more information, please contact Dan_Lundin@takarabio.com.
Phone +46 765 250 960