QA Specialist - Microbiology
Procella Therapeutics AB / Kemiingenjörsjobb / Stockholm
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hela Sverige At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.
We are now seeking a highly motivated individual to join us as QA Specialist - Microbiology.
About The Position
This is a role for someone who is ready to work in a senior QA role with many internal and external contacts. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing and developing company that makes a difference. As a QA Manager, you will provide QA oversight towards GMP clean rooms (grade D - Grade B), while ensuring cGMP of internal manufactured products. This role will work closely with cross functional teams internally (development, manufacturing, QC). Reporting to the Head of Quality, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.
Responsibilities
• Handle various documentation revisions (including SOPs etc.)
• QA representative in validation activities (CV, IQ/OQ/PQ) of facilities, equipment/instruments, material transfer etc.
• QA member in various cross-functionally projects such as tech transfers
• Act as an expert and be an advisor regarding GMP in quality issues from a microbial view
• Develop and perform GMP training within Procella
• Be responsible for GMP compliance within your area
• Ensure products, processes, systems and procedures are in compliance with relevant authority requirements (FDA, EMA, ICH etc) and Procella procedures
• Responsible QA for potential deviations, risk assessments and change controls within own area
• Responsible for assessments and statements relating to microbial evaluation
• Handle GMP quality related issues both internally and externally with Procella's GMP suppliers
• Handle, review and approve quality related documentation
• Participate/support in audits and inspections
Qualifications
• You must have experience of working with GMP environmental monitoring / microbial laboratory
• be able to speak / write Swedish and English fluently
• you have an understanding in biological manufacturing and testing
• You have an understanding in requirements regarding aseptic manufacturing and clean rooms
• A high-level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
• You have at least 7 years of experience from the pharmaceutical industry, preferably within QA
• Extensive GMP knowledge and experience
Personal attributes
You are independent, good at driving your own work forward and you have a good ability to take your own initiatives. You are a natural QA leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, with you handle new situations with ease as well as many different issues at the same time.
Equal Opportunity Work
At Procella we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
If you are interested in this unique opportunity, please submit your application (including a cover letter) today. We will review applications on an ongoing basis and hope to fill the position as soon as possible.
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SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 60 employees from more than 20 nationalities.
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2024-03-06
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Procella Therapeutics AB (org.nr 559036-4609),
https://procella.se/ Arbetsplats SmartCella/ProCella/SmartWise/SmartCella Solutions
Jobbnummer 8121274
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