Senior Scientist, QA Systems Compliance 100%
CSL
Switzerland, Lengnau
vor 11 Tg.

Job Description

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 Recombinant Facility (RCF) in Lengnau 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

Senior Scientist, Quality Assurance Systems Compliance (F / M) 100%

This position will oversee the compliance with laws, regulations, health authority expectations, and internal requirements with respect to Audits / Inspections, Quality Agreements, Changes, Deviations, CAPAs and PTCs in the pharmaceutical industry.

Thus a minimum of 5 years of professional experience in handling these quality system elements is required.

During the period of establishing the new manufacturing site the position holder will be part of the facility program and implement the necessary systems within the facility.

In particular the position holder will be involved to design and establish within the above mentioned areas of quality systems the operational structures.

The main responsibilities of this position are :

  • Overseeing and implementing the required functionalities and templates to ensure that GMP relevant Audits and Inspections are performed appropriately
  • Creating and maintaining the necessary structure in the Change, Deviation, CAPA and PTC handling system to ensure operational readiness
  • Driving the enhancement to the necessary structure and business processes in the afore mentioned Quality Management Systems to ensure operational readiness
  • Contributing to the architecture of the Lengnau QMS and the Lengnau trainings contents (various topics)
  • Your qualifications and Experience :

    Education

  • Master Degree or equivalent (Dipl.-Ing.) in Engineering or Life Sciences (Biology, Chemistry, etc.)
  • Experience

  • Minimum 5 years of experience in developing, implementing and improving cGMP QMS Systems
  • Strong knowledge of cGMP including current knowledge of industry guidance documents and standards
  • Strong Knowledge in MS Office (Word, Excel, PowerPoint, Visio, Outlook) and Trackwise is a must
  • Competencies

  • Fluent German required, proficiency in English (written and spoken)
  • Able to work well both independently and in a team environment to ensure successful outcomes
  • Drive for Results & Customer Focus
  • Problem Solving & Organizational Agility
  • 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.

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