Specialist, QM Manufacturing (M/F) 100%
CSL Behring
CH, Lengnau
vor 3 Tg.

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 Behring 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.

Are you interested in being part of this exciting project?

We are looking for an experienced

Specialist, QM Manufacturing (M / F) 100%

This position requires an experienced quality specialist with profound experience in working within quality elements in Pharma industry such as :

  • Deviations and CAPA management,
  • Change management,
  • GxP document writing and trainings
  • Audits / Inspections
  • Experience of improving / establishing these systems for the pharmaceutical / biotech industry will be a real added value for this role.

    At this stage of the green field project, the position holder will be involved to design and establish document management system and training handling system within manufacturing department (includes USP, DSP, Media Buffer, FF, Supply and logistics).

    Technical Responsibilities

  • Deviation and change management : responsible to coordinate, review and complete the deviation and changes.
  • Root cause analysis and CAPA management : responsible to create and maintain the necessary structure of the RCA and CAPA.
  • Train the manufacturing colleagues to use Fishbone, 6M and 5 Whys techniques.

  • Training matrix and training management : responsible to have training contents (CBT, ILT, OJT, Qualification) of the operators, specilaists and managers appropriately defined.
  • Creating and maintaining the necessary structure in the training matrix of manufacturing teams. Who needs to be trained on what and how

  • Make sure, for the concerned area of responsibility that operators are qualified during CVQ and are operational to perform during PQ / PPQ under GMP conditions.
  • Contributes to the architecture of the Lengnau QM Manufacturing documentation and trainings contents (various topics).
  • Oversee that the quality and compliance requirements are met for manufacturing documents (SOPs / WI etc).
  • Participate and where needed lead the risk assessment activities using ICH Q9 guidelines.
  • Inspection readiness : prepare the manufacturing for internal and external audits and inspections.
  • Maintain hygiene standards in the area allotted in collaboration with transversal teams.
  • Education and Experience

  • Bachelor's degree preferably in chemistry, pharmaceutical, biochemistry, technical or related field required. Master degree in life sciences (MSc or equivalent) in a Scientific / technical discipline preferred.
  • German and English is a must.
  • A minimum of 5 years of professional experience, out of which 3 years in handling quality system.
  • Elements such as CAPA, training, document management and risk management in pharmaceutical industry, are required.
  • Experience of working within automated systems, PCS-MES etc.
  • Experience of working with trackwise and SAP.
  • Knowledge of ICH, Swissmedic, FDA and EU GMP guidelines.
  • 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.

    Worker Type : Employee

    Worker Sub Type : Regular


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