Arbejde Senior Associate for Documentation and Support in Large Scale Manufacturing unspecified BIOGEN (DENMARK) NEW MANUFACTURINGApS - jobtilbud
reference: 4895446
documentId: 4895446
connectionPointId: 7
lastModificationDate: 1540370470076
stillingsbetegnelse:
Senior Associate for Documentation and Support in Large Scale Manufacturing
jobbeskrivelse:
Do you want to liaison Biogen‘s Manufacturing Documentation activities in close collaboration with our Quality Assurance (QA) and other Production Support Teams?
Job Category
Manufacturing
Requisition Number
35796BR
Job Description
As our new colleague you will be responsible for administering and executing document updates related to process improvements and participate in our tech transfer projects. In this role, you will use your experience to set up the production for success and thus engage closely with your colleagues in QA, Manufacturing Sciences and our Engineering function. Knowledge and flair for compliance is key, and not least your ability to use your professional skills to provide supportive solutions with a focus on our end users - shop floor.
You will become part of a department of 20 people divided into 2 teams who all work independently but share knowledge and best practice to support the production the best possible way. Our main focus is maintenance and continuous improvements of the manufacturing document packages as well as developing new packages during tech transfers
Primary Responsibilities
• Develop SOP’s and batch records (Master Production Records (MPRs) and Solution Records (SRs))
• Drive document related projects incl. host meetings and coordinate across departments
• Implement corrective actions related to documentation as appropriate
• Participate in execution of change requests
• Perform batch preparation
• Give input to exceptions and investigations related to production
• Supply general quality-related support of audits and inspections
Qualifications
• Solid GMP experience (or alternatively ISO)
• Good English skills verbally and in writing
• Excellent communication skills as you will lead departmental and/or cross functional meetings
• Strong collaboration skills as you must be able to nudge colleagues to ensure tasks are completed within deadline
• Experience in conducting and writing investigations and change requests
• You have a systematic approach and ability to work under the documentation requirements laid down by GMP
• You work thoroughly and pay attention to details
• You work independently and can bring your knowledge into action proactively
Your area of focus will cover all documentation relevant for manufacturing of drug substance - Master Production Records, Solutions Records, SOPs, Work instructions, etc. Thus, process knowledge in one or more of the following areas will be highly appreciated: Cell Culture, Purification and/or Solutions (media and buffer preparation, including dispensary).
Education
Master of Sciences in Engineering, Pharmacy, Chemistry, Biotechnology or equivalent is required.
Please send your application as soon as possible as we screen applications on an ongoing basis.
Employment Category
Full-Time Regular
Experience Level
Entry Level
numberOfPosts: 1
jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C3122
abstractJV_contact_0: Please apply using one of the specified channels
positionTypeCode: directhire
contractTypeCodes_0: fulltime
Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS
source: DK-STAR
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