Quality Manager
Biolamina AB / Chefsjobb / Sundbyberg
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BioLamina is currently looking for a dedicated and meticulous Quality Manager to strengthen our Quality department, responsible for the overall administration of the Quality Management System (QMS). Quality Management at BioLamina is today performed according to the ISO 9001:2015 standard and aiming towards complying to higher quality standards in the future. The responsibility of the Quality department is to establish in-house quality procedures, standards, specifications, and systems, and to support other departments to ensure that the operations within BioLamina meet the outlined requirements.
You will be working in our office and production facility in Sundbyberg in a highly multicultural environment.
Main tasks and responsibilities
Take active part in the continuous development of the QMS
Ensure that the QMS is functioning properly according to the ISO9001:2015 standard
QA review and approve documentation such as deviations, batch records, change control, controlling documents, complaints, CAPA, study plans and reports.
Ensure that BioLamina's products comply with release specification, and release final product
Provide QA support to other functions within BioLamina regarding different quality and regulatory standards (ISO, GMP, etc)
Provide quality training
Nurture Quality culture in the company - develop and maintain good cooperation with all departments
Organize annual ISO internal audits
Plan, participate and report outcome of external audits
Participate in quality and regulatory discussions with partners and customers, e.g., regarding quality agreements and questionnaires
Evaluate and approve suppliers
Qualifications
Bachelor of Science in pharmacy, biotechnology, chemistry, biology, engineering or similar
At least 2 years' experience from working in Quality department in Life Science industry
Deep knowledge of the regulatory requirements in the Pharmaceutical/Medical Device industry, e.g., GMP, ISO 13485.
Practical experience of working with investigations and assessments of deviations, changes, CAPA and risk management.
Experience from Quality Assurance of protein manufacturing is a bonus.
Experience of GAMP5 and qualification/validation of equipment and computerized systems is a bonus.
Sense of accountability, with attention to details.
Problem solver with collaborative mindset.
Excellent English skills.
Good IT skills
Proactive and aptitude for learning new things and willingness for change.
Location
The office is in central Sundbyberg, Stockholm, with good communications through public transportation (SL), e.g. subway, light railway, and commuter trains. There are also indoor parking opportunities available.
Working at BioLamina
You'll be working with colleagues who are dedicated and high performing. We believe our products can change the world and we have high ambitions to do so. All employees are important and every employee counts. BioLamina is a learning organization and we do this from each other and from the outside. We value our employees and we are committed to ensuring that the work environment is pleasant, sustainable, and safe. BioLamina is an ISO-certified company, we provide quality products and take pride in the quality in everything we do.
BioLamina is a member of IKEM - Innovation and Chemical Industries in Sweden. IKEM has collective agreements with relevant trade unions of the sector, and as a member, Biolamina is part of the collective agreement. Employment with us includes a beneficial pension policy and generous wellness allowance. There is insurance for sickness, in case of loss of income, counseling and call support, rehabilitation as well as life and accident insurance.
We proud ourselves in providing an equal workspace making sure people are given equal opportunities, equal pay, and are well accepted for their differences. We embrace diversity and inclusion in all aspects of our business.
Application
Please submit your application before 30 of April 2021 to
career@biolamina.com. Please include the line "Quality Manager" in the e-mail subject line.
We will have an ongoing selection process so please send in your application as soon as possible. If you have any questions about the position, please contact Interim Quality Lead Kimberley Cheng or HR Manager Maria Pihlgren.
About BioLamina
BioLamina AB is a Swedish based Biotech company that originates from scientific innovations at Karolinska Institutet. Our main products are recombinant laminins, human proteins that are being used to maintain and expand pluripotent stem cells and other primary cell types and for subsequent differentiation into different specialized cell types. BioLamina is revolutionizing cell culture and our products are being used by researchers to develop cellular therapies, building on the era of regenerative medicine. Founded in 2009, BioLamina has grown organically and today we are about 30 employees who develop, produce, market, and sell cell culture research reagents to academic and industrial scientists globally. For more information, please see:
http://www.biolamina.comPubliceringsdatum2021-04-01Så ansöker duSista dag att ansöka är 2021-04-30
AdressBiolamina AB
Löfströms allé 5A
17266 Stockholm
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Biolamina AB (org.nr 556764-1872)
Löfströms allé 5A (
visa karta)
172 66 STOCKHOLM
Ansökan E-post:
career@biolamina.com Arbetsplats BioLamina AB
Jobbnummer 5667684
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