Quality Assurance Manager
Takara Bio Europe AB / Organisationsutvecklarjobb / Göteborg
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The Quality Assurance Manager will be responsible for building, developing, implementing and maintaining a Quality System that includes R&D, Manufacturing and GMP activities. The QA Manager will also need to secure quality aspects throughout the company culture, extending to vendors, suppliers and consultants. Strong organizational, leadership and team skills will be important to guiding and aligning the internal team and external consultants.
Position Title: Quality Assurance Manager
Department : Operations
Reports to: Director, Operations
Primary Duties & Responsibilities
• Develop, implement and maintain the quality function of Takara Bio Europe.
• Management of the Quality Management System incorporating the requirements of cGMP and ISO9001.
• Act as Takara Bio Europe's responsible person.
• Management of vendor assessment program.
• Review manufacturing documents for material qualifications and product release.
• Ensures finished products conform to government and company/group standards and satisfy good manufacturing practices regulations.
• May lead investigations and resolve potential product quality issues.
• Provide guidance and leadership to Quality Assurance and Quality Control personnel.
• Communicates the company's quality strategy and its quality programs, including quality assurance to internal and external stakeholders.
General Duties & Responsibilities
• Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
• Provides guidance to colleagues within the extent of established company Quality policies.
• Recommends changes to Quality policies and establishes procedures.
• Exhibit knowledge of professional ethics, laws and regulations.
• Maintains broad knowledge of Quality principles and theories including Good Manufacturing Practice (GMP).
Education Requirement (minimum)
• BSc or MSc in Pharmacy, Cell Biology or related field
Experience Requirement (minimum)
• Minimum of 5 years related experience; must have previous experience managing projects.
• Strong 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.
• Expert knowledge of Quality principals and concepts, knowledge of ISO 9001 is preferred.
• Complex problem solving and persuasion 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 3434010
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