32 days ago on sjobs.brassring.com

QA for QC Specialist (Microbiology)

Novartis Pharma Schweiz AG

  • Work region
  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

QA for QC Specialist (Microbiology)

Job ID 221369BR Position Title QA for QC Specialist (Microbiology) Division Novartis Technical Operations Business Unit NTO QUALITY Country Switzerland Company/Legal Entity Switzerland Novartis Pharma Stein AG, Stein Functional Area Quality Job Type Full Time Employment Type Regular Sourcing Statement You are applying to be part of the Novartis Talent Pool.We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV. Job Description The QA for QC Specialist (Microbiology) is a member of the QA for QC operations team. The team owns the quality aspects of all QC release and microbiological monitoring relevant processes. The QA for QC Specialist (Microbioloy) provides QA oversight for all GMP related QC activities in QC Microbiology within Stein Steriles. Main focus lies on the product specific release related analytical activities within those labs und furthermore support additional non release related analytical activities.

• Review/approval of lab documents/journals and transfer documents
• Monitor laboratory procedures and ensure compliance with GMP, safety, hygiene and environmental regulations in laboratories
• Processing of OOE/OOS records and laboratory deviations, ensure adequate failure investigations and arrange corrective measures
• Audit and inspection support
• Updating non-complex SOPs
• Usage Decision (release of analytical results)
• First point of contact for internal local customers
Minimum requirements • Technical education or Bachelor/Master Graduate and several years relevant work experience in the field of Microbiology/Biology preferred
• Advanced quality understanding and knowledge of the current technical analytical requirements from pharmacopoeia (USP, Ph.Eur) and knowledge of the relevant guidelines (FDA, EU, PICIS, ICH)
• German: fluently spoken/written, English: very good knowledge spoken/written
• Flexibility and ability to set priorities and to work according to schedule