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QA Release Senior Scientist

Die komplette Bewerbungsadresse entnehmen Sie bitte dem Stelleninserat.

CSL Behring is a leading global biotherapeutics company committed to its promise to save lives. The parent company, CSL Limited, is headquartered in Melbourne, Australia.

In May 2014, CSL selected Lengnau in the Canton of Bern in Switzerland as the location of a new manufacturing facility to support the commercial production of our promising novel therapies. The CSL Lengnau AG is part of CSL’s ongoing global expansion strategy to support the company’s long-term growth plans.

The new plant in Lengnau with its highly advanced facilities will manufacture innovative and promising therapeutics with the aim to enhance the quality of the patient’s lives. One of the main products will be a recombinant coagulation factor to treat hemophilia B patients.

The Lengnau site project generates an investment of approximately a billion Swiss Francs and will create around 300 new jobs when it is fully operational in 2021.

Are you interested in being part of this exciting project?

We are looking for an experienced

QA Release Senior Scientist

The role provides execution of all QA Release related activities for the CSL Behring Lengnau AG legal entity. During the period of establishing the new manufacturing site the position holder will be part of the Lengnau program and support the implementation the necessary quality systems elements to operate QA Release function tasks.

In particular, the position holder will support different departments such as manufacturing, supply chain, engineering to ensure documents are written in such a way that GxP principles are fulfilled and compliance to the filing is ensured, also within the used electronic systems as e.g. SAP.

Main responsibilities:

General Duties:

  • Acts as delegate of the Sr Manager
  • Provides support to the entire Lengnau organization in the area of responsibilities of QA Release
  • Ensures and executes within his/her area of responsibility the collection and compilation of the defined key performance indicators (KPI) for review and release activities
  • Collaborates and ensures information exchange with external contract manufacturing, testing and packaging partners as well as with internal CSL stakeholders

Technical duties – during Lengnau Program Phase:

  • Review and approve the operational elements such as Policies and SOPs and any other procedural documents as applicable
  • Review and approve paper/electronical batch records for drug substance production (up- and downstream) as well as filling and packaging operations
  • Draft, review and approval of material specification documents
  • Support electronic system implementation projects (e.g. SAP, StarLIMS) during test phase

Technical duties – function related

  • QA Review and approval of master batch records
  • Perform batch record review of LGN products according to ‘Review by Exception’ concept
  • QA Batch Record Review for marketed products manufactured / tested at contract manufacturing organizations (CMO)
  • Attendance to Health Authority inspections within the area of responsibilities
  • Support as necessary QA departments with review and writing of documents and reports

Education:

Master Degree in Natural Sciences Subjects (e.g. Chemistry, Biology, Biotechnology etc)

Experience:

  • 3 to 5 years in a biotech company or in aseptic filling within the pharmaceutical industry and not less than 1 year in quality area
  • Knowledge of pharmaceutical manufacturing processes with particular focus on Biologic Drug Substance/Product and Aseptic Filling
  • Good proficiency in German and English is required
  • Experience in Master Batch Records, Batch Review and Release and Logistic operations is an asset
  • Experience in SAP and LIMS is an asset

Competencies:

  • Communicates effectively
  • Instills trust
  • Ensures Accountability
  • Drives Results
  • Manages ambiguity

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.

  

Adresse

CSL Behring Lengnau AG
Talent Acquisition Team EMEA

Website https://csl.wd1.myworkdayjobs.com/CSL_External/job/EMEA-CH-Lengnau-CSL-Behring/QA-Release-Sr-Scienti

Bern / Lengnau / Marburg (Germany) or Bern (Switzerland) / Marburg (DE) oder Bern (CH) / Lengnau BE

Details zur Firma

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