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Laboratory Specialist QC Microbiology 65%

ELAN Personal AG

Employment type
Part-time
Workload
65%
Location
Kaiseraugst
Company
ELAN Personal AG, Leimgrubenweg 16, 4053 Basel
First posted
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Laboratory Specialist QC Microbiology 65%
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Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-standing client, F. Hoffmann - La Roche AG in Kaiseraugst, we are looking for a

Laboratory Specialist QC Microbiology 65%
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Background:
The perfect candidate: has a completed degree in life sciences (e.g., biotechnology, microbiology, or bioengineering) as well as at least two years of experience in the pharmaceutical industry within a GMP-regulated environment. They bring sound knowledge of pharmaceutical quality systems, act consistently in an orientation towards quality and compliance, and impress through strategic thinking as well as the ability to take responsibility and reliably achieve results. Through their structured, team-oriented way of working and fluent German and English skills, they build trusting relationships and actively contribute to continuous process improvement.

Tasks & Responsibilities:

  • Initiating and processing deviation reports (DRs) and assessments including consultation with affected interfaces and QA
  • Management of the end-to-end process from the triggering of the deviation after its detection via RCA and 5-Why to the prevention of further occurrence through implementation of necessary corrective/preventive actions (CAPA)
  • Planning, coordination and documentation of change requests for processes and methods within the unit
  • Creation and updating of testing instructions, SOPs and other GMP documents
  • Professional execution of special assignments as well as general laboratory and service work according to instructions from the Planning and Coordination Leader (PCL) or Unit Leads and their documentation according to current current good manufacturing practice (cGMP) guidelines
  • Ensuring competent, efficient and GMP-compliant analytics by observing all relevant guidelines, SOPs, as well as regulatory and registration-relevant requirements
  • Planning, coordination and collaboration on cross-group projects within QC and with the manufacturing customers
  • Readiness to work on public holidays (occasionally)

Must Haves:

  • Completed degree in the field of life sciences e.g. as biotechnology; microbiology; bioengineer or comparable degree (Bachelor or Master)
  • Preferably 2 years of experience in the pharmaceutical industry and in a GMP-regulated environment or comparable (e.g. as a microbiologist; QA Assistant)
  • Expert knowledge of pharmaceutical quality systems and standards
  • Fluent German and English skills
  • Taking on responsibility, determination and achieving expected results
  • Building trusting and successful relationships
  • Very good organizational skills, strategic thinking and implementation of strategies into actionable plans
  • Team-oriented mindset with a view to continuous improvement of processes and the ability to deliver constant performance

Nice to Haves:

  • Training/experience in microbiology and/or sterility assurance
  • Strong understanding of quality and compliance and corresponding action

What is offered to you:

  • A chance to participate in one of the most significant pharmaceutical companies in the world
  • Modern campus with lots of green spaces and meeting zones
  • Varied activity profile
  • Further training opportunities through temptraining
  • Collaboration in a dynamic and motivated team

You are welcome to send your complete application documents to Ms. Marianne Buser.

Basel Basel-Land Aargau Chemistry Pharma laboratory QC Microbiology bioengineer GMP QA quality systems quality assurance

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