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QA/QC Expert

  • Salary: CHF70 - CHF80 per hour
  • Job type: Contract, Full-time
  • Location: Basel
  • Sector: QA / Testing
  • Date posted: 13/11/2017
  • Job reference: J377165ASVT-131117

QA/QC Expert - Basel - 100%

Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.

For our international client based in Basel, Experis is looking for a QA/QC Expert for a contracting position of 1 year.

General information:

- Start date: 08/01/2018
- Duration: 1 year
- Work location: Basel
- Workload: 100%


Tasks & Responsibilities:

  • Defines and implements the business processes and SOPs necessary to maintain a robust Quality System within External Supply affecting the laboratory activities (e.g. management of changes, maintenance of testing monographs)
  • Support Implementation of Guidelines at external partners and suppliers
  • Lead programs and initiatives to implement changes and to remediate where required
  • Interprets stability data, analyzes trends, and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories. Provide corrective actions to address immerging stability issues.
  • Support External Suppliers Qualification process
  • Support Tech Transfer assessments for analytical method transfers.
  • Lead QC aspects of Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
  • Support assessments of analytical Change Control records for acceptability. Define studies needed to support the changes.
  • Interacts with the External Supplier to guarantee suspect analytical results investigations are managed in agreement with the standards
  • Ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation. Support programs and initiatives to implement changes to, and upgrade Testing Monographs where required
  • Support site readiness for Health Authority inspections & participate in audits on request.
  • Escalate any issues or instances of instability per the escalation policy, and initiate any market action that is required.
  • Support analytical trouble shooting as needed.

You bring for this role the following qualifications:

  • University degree in Pharmacy, Biochemistry, Chemistry, or another related science
  • Fluent in English
  • 5-8 years experience in the pharmaceutical industry
  • Mind. 5 years experiences in QC, method development, validation or stability testing
  • Thorough knowledge of cGMP requirements
  • Thorough knowledge of cGMP, ICH guidelines, regulatory requirements & risk management
  • Good leadership skills and experiences in leading project teams
  • Strong track record in project management

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Stéphanie Vogt on +41 61 282 22 16.

Even though this position may not be the perfect fit for you, please reach out to us, as we have hundreds of open positions at Experis IT across Switzerland.

Check out all of Experis' job openings at www.experis.ch or visit my personal page https://www.experis.ch/stephanie-vogt and connect to me on www.linkedin.com/in/stephanie-vogt2

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