Quality Assurance Associate
Takara Bio Europe AB / Organisationsutvecklarjobb / Göteborg
2017-04-11
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The Quality Assurance Associate provides the organizational assurance that we meet safety, quality, identity, purity and accessibility requirements of our products and services. The QA Associate plays an important role that supports the business in delivering and improving products or services that meet the needs of our customers. As a member of the Quality team, the QA Associate, ensures that work performed is consistent with the overall strategic direction of the Quality department and the organization as a whole and is accomplished by working in collaboration with members of the department or other internal team members or external consultants.
Position Title: Quality Assurance Associate
Department : Quality Assurance
Reports to: Quality Assurance Manager
Primary Duties & Responsibilities
• Maintenance of Quality System processes (i.e., document management, validation, change control, corrective action/preventative action, auditing, training and quality control, etc.).
• Writing and reviewing SOPs and other documents to maintain the Company's Quality System.
• Assisting in batch record review.
• Reviewing deviations to ensure adequacy of investigations, root cause and appropriate CAPA.
• Participating in validation, audits and performing training as necessary.
General Duties & Responsibilities
• Relies on instructions and pre-established guidelines to perform the function of the job.
• Normally receives no instructions on routine work, general instructions on new assignments.
• Exhibit general knowledge of professional ethics, laws and regulations.
• Maintains knowledge of Quality principles and theories including Good Manufacturing Practice (GMP).
• Other required duties as may be assigned.
Education Requirement (minimum)
BSc or MSc in Pharmacy, Cell Biology or related field
Experience Requirement (minimum)
Minimum of 2-5 years related experience
Knowledge of GMP regulations required (FDA/EU/ICH).
Experience within biologics is essential and within the field of, cell or gene therapies a distinct advantage.
Good knowledge of Quality principals and concepts, knowledge of ISO 9001 is an advantage.
Good problem solving skills and being accurate and result-driven.
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.Publiceringsdatum2017-04-11Så ansöker duSista dag att ansöka är 2017-05-05
FöretagTAKARA BIO EUROPE AB
AdressTAKARA BIO EUROPE AB
ARVID WALLGRENS BACKE 20
41346 GÖTEBORG
KontorsadressArvid Wallgrens Backe 20
Jobbnummer 3434012
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