Posted to MedZilla on 4/28/2017


ProClinical

Switzerland, Quality Assurance Specialist QA_BK_11529-MZ


 
 

A global biotechnology company is currently looking for a Quality Specialist to take charge of the QA interface with manufacturing and testing partners for assigned products/projects by ensuring the quality of product/process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements. The position is full time and based in Switzerland.

Responsibilities:

  • Manage the QA interface with manufacturing and testing partners for clinical and commercial products, ensure quality issues are appropriately investigated, tracked and resolved in a timely manner
  • Ensure appropriate corrective and preventive actions are defined, implemented and their efficacy is evaluated
  • Provide technical support for the manufacture of products at Contract Manufacturer Organisations (CMOs)
  • Ensure that the CMO maintains quality systems that are in a state of compliance
  • Participate in regulatory inspections and support regulatory inspections at CMOs. Perform risk assessment as preventive measure or in response to product/quality system failures, investigations and regulatory inspections. Coordinate of preparation and review of domestic and international regulatory filings
  • Participate in the preparation of the annual product review, Responsible for the quality aspects related to the transfer or set-up of drug products processes to CMOs, including but not limited to risk assessment, validation protocol and report review and approval, defining and following up on quality and performance indicators.

Qualifications:

  • Minimum Bachelor’s degree, Master degree preferred, in a scientific topic (Pharma, Chemistry, Biology, Biochemistry etc.)
  • A minimum of 3 years of experience in similar position in pharmaceutical or biotechnology industries
  • Relevant experience in either manufacturing (packaging), development, quality or regulatory;
  • Understanding of cGXPs, quality systems and regulations (FDA and EU)

This is an excellent position for a Quality Specialist who would like to develop further experience in biological medication. Candidates from EU region are welcome

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please send your CV to Beata Klecz on [click here] or upload to our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.


Please visit our website at www.proclinical.com

 
 


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