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 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.
- Scheduled work performed during weekends may from time to time be a requirement.
- Other required duties may be assigned.
Primary Duties & Responsibilities
- 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.)
- Follow company Quality Management System processes and procedures.
- Review and assessment of batch documentation and QC documentation.
- Responsible for environmental control of clean room areas in the facility.
- Issue, review and assess QC batch related documentation and environmental control documentation.
- Assess and Trend environmental control results.
- Take part in general maintenance activities in the clean room area.
- Issue Change documentation and Deviations related to the Quality function.
- Issue of qualification and validation documentation for QC equipment and systems.
- Participate in qualification and validation activities for systems, equipment, facilities and 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.
- Take part in audits and regulatory inspections.
- As needed take part in or act as facilitator for Quality related Risk Assessments.
- Train employees in GMP, QC and other relevant areas.
Education/ Experience Requirement
- MSc in Pharmacy, Cell Biology, Microbiology or related field
- Relevant experience preferably in the biotech/biologics area
- Experience of work with ATMP and/or stem cells is an advantage
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