Arbejde Associate for Manufacturing Compliance unspecified BIOGEN (DENMARK) NEW MANUFACTURINGApS - jobtilbud
reference: 4890181
documentId: 4890181
connectionPointId: 7
lastModificationDate: 1539164891590
stillingsbetegnelse: Associate for Manufacturing Compliance
jobbeskrivelse:
Are you interested in Compliance and would you like to be part of a dynamic and competent team in Biogen, the world’s oldest independent biotech company. We are looking for an Associate to join the Manufacturing Compliance team for Assembly, Label & Pack (AL&P) at the Hillerød site
Job Category
Manufacturing
Requisition Number
35926BR
Job Description
In this role you provide support to AL&P in compliance and GMP related matters. You initiate and investigate deviations and establish and implement comprehensive corrective and preventive actions to prevent reoccurrences and improve compliance. You ensure compliance of GMP documents and participate in optimization projects.
Key responsibilities:
Execute deviations, CAPAs and procedures updates
• Initiate and investigate deviations and establish comprehensive corrective and preventive actions (CAPA) to prevent reoccurrence and improve compliance
• Ensure on-time closure of deviations and CAPAs in accordance with defined timelines
• Prioritize tasks to support defined release targets
Maintain compliance of GMP documents (procedures, batch records, forms)
• Review GMP documents for accuracy
• Perform updates to GMP documents and create new GMP documents when required
• Support periodic review of GMP document
Support AL&P
• Provide support to daily production in compliance and GMP related matters
• Participate in problem solving, occasionally across departments
Support and lead optimization projects
• Be a part of optimization projects in AL&P
• Support implementation of simplified processes
Represent AL&P at audits
Collaborate with QA to ensure alignment on interpretation of GMP issues.
Biogen offers a dynamic working environment in an exciting and rapidly growing industry where multi-cultural teams from all over the world work collaboratively on products that change lives. We have an exciting product pipeline and are seeking positive people with a strong drive.
*LI-DEN2
Qualifications
You have a Master’s degree in Pharmacy, Engineering or similar or a Technical Degree with thorough experience and knowledge of GMP and GMP regulation.
You understand and are able to execute against regulatory requirements. You have good spoken and written skills in English and Danish and a high level of technical writing skills. Experience from the Biotech or Pharmaceutical industry working in a GMP environment will be an advantage.
As a person you are analytical and structured with a high quality mind set. You enjoy working independently and are able to work with tight deadlines. You have a good sense of prioritization between tasks to meet the deadlines.
Education
Master’s degree in Pharmacy, Engineering or similar.
Technical degree with thorough experience.
Please apply latest Friday 19th of October 2018.
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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