Experienced Validation and Compliance Specialist
BioInvent International AB / Kemiingenjörsjobb / Lund
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hela Sverige Visa alla jobb hos BioInvent International AB i Lund At BioInvent, we are experts on antibodies and cancer biology and strive for developing first-in-class immuno-modulatory antibodies to treat cancer; treatments that have the potential to considerably improve cancer therapy and the life quality of cancer patients. In our biotech company we are approximately 60 employees and we are covering all parts for drug development, including preclinical research, manufacturing and clinical trials. Together we all create the exciting future of BioInvent and we welcome you to be part of it - as our Validation and Compliance Specialist.
Overview
You will work with Validation, improve and LEAN our document flow and processes as well as follow up and drive compliance activities forward such as deviations and CAPAs.
Key responsibilities
• Provide equipment, system and facility qualification guidance and strategy
• Creation and execution of qualification protocols (DQ/IQ/OQ/PQ), including identification and resolution of non-conformances/deviations
• Write or Review summary reports for qualification testing
• Perform temperature mapping and other miscellaneous validation activities
• Report status and progress of qualification activities to the Leadership team
• Perform investigations and implement corrective actions related to CAPAs and deviations
• Oversee and follow up on compliance activities such as calibrations, scheduled maintenance and periodic review
• Be SME for validation and attend/present during audits and inspections
Requirements
You have a degree in life science or similar fields, with at least five years of validation experience. You have a good understanding of manufacturing as well as documentation processes. Knowledge and experience with GMP and Lean. You are proficient in written and spoken English & Swedish.
The position is office based in Lund.
Skills and Capabilities
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. Personal suitability is of great importance and we believe that you are efficient, have a strong commitment and ability to drive processes forward. You understand the importance of achieving results, keeping deadlines and to secure high quality within your work. You are enthusiastic and enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
If you match the described profile and would like to contribute to important cancer research as a part of BioInvent and our exciting future, you are welcome to apply for the position!
Please send your application (CV and personal letter) through our website. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2018-12-09. Naturally, all applications will be treated in the strictest of confidence.
BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen tfn: 046-28 68 568
Jenny Nilsson, Unionenklubben, tfn: 046-28 62 536
Publiceringsdatum2018-11-27Så ansöker duSista dag att ansöka är 2018-12-09
Klicka på denna länk för att göra din ansökanFöretagBioInvent International AB
KontorsadressSÖLVEGATAN 41
Jobbnummer 4483565
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