QC Compliance Scientist (m/f/d)SwitzerlandR-0990681094 CSL Behring Lengnau AG
With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
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 Facility 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
QC Compliance Scientist (m/f/d)
The job holder is accountable to make sure that processes, equipment and analytical methods, are designed and operate in such a way that health authorities requirements/expectations are met.
In scope of such a job there are two main areas: HA compliance and material management.
To the HA compliance belong the following areas:
- Audit readiness
- Compliance to Pharmacopoeias, cGxP, ICH, PDA, CSL Policies and global procedures, etc.
- Non Conformities (deviations) and change management
To material management belong processes related to the following areas:
- Sampling plans
- Material qualification reports
- LIMS Master Data
Processes implementation (procedural documents owner): Implement and mantain the state of the art for the following processes and relevant procedural documents:
- Out of Spec, Out of Trend and Out of Expectations (OOX).
- Testing of Raw materials, consumables and processes chemicals
- Method transfer, verification and validation
- Sampling plans
- Reference Standards
For any materials associated to a quality inspection plan make sure:
- Specifications are drafted in collaboration to the process owner
- Sampling plans are in place
- Compliance to the approved specifications is properly documented per each incoming batch.
- Collaboration and expertise in the resolution of technical problems or questions (investigations, task forces, questions from authorities)
- When required, participate to the implementation an manteniance of other QC processes.
- Liaise with the QC Development team to ensure analytical methods and processes are developed and implemented as applicable.
- Lead the implementation of both local and global projects within the QC department.
- Promotes an accountable working environment by sharing management guidance and expectations, full and transparent access to the necessary information and when appropriate, escalating possible conflicts or behavioral issues as soon as they arise
- Proactively support continuous improvement of QC compliance and performance
- Establishes and maintains contact to external partners such as suppliers, contract laboratories and universities
Education and Experience:
- Degree (Bachelor or higher) in Chemistry or Life Sciences
- 1 to 5 years of experience in GMP regulated industries; former experience in worldwilde corporate based companies is an asset.
- > 1 years experience in pharmaceutical quality control.
- Experience in QA or Validation area is an assett.
- Proven experience and knowledge in analytical method development, method validation and analytical issue management
- Languages: Working proficiency in English and in German is required; other Languages are an asset.
- Proved experience in projects related context.
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 this in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.