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QA Specialist

Administration / Secretarial
Lausanne
English

Location: Vers-chez-les-Blanc, Lausanne, SwitzerlandEntity: NRC (Nestlé Research Center)
Activity rate: 100%
Contract: temporary contract, one-year contractStarting date: ASAP Randstad has over 55 years' experience in Human Resources management. Under the Randstad Inhouse Services (RIS) concept, Randstad becomes a complete partner for its international clients. For our client, Nestlé Research Center, we are looking for a :


QA Specialist (100%)


This position is an hybrid one and your main responsibilities will be to:

  • Establish and maintain effective work relationships within the department, the Company, and its global affiliates
  • Develop and maintain a culture in which quality is top priority and a spirit of continuous improvement is fostered, as well as strict awareness of company and quality goals
  • Support integration, acquisition, and new product/market activities as necessary

Pharma Commercial CMC QA Specialist (70%):

  • Review & Approval of Master Production Records, Specifications
  • Review of executed batch records, deviations, change controls
  • Batch disposition
  • Resolution of production related issues
  • Review and Approval or Quality Control protocols, reports, deviations
  • Review and Approval of Process Validation Protocols and Reports
  • Inspection readiness (CMO and Internal GMP)
  • Product complaint intake from call centers and investigation
  • CMO and GMP laboratory audits
  • CMO and GMP laboratory Quality Agreements
  • Annual Product Quality Review
  • Biologic Product Deviation Report assessment
  • Review of CMC related regulatory filings
  • Distribution Quality ? 3PLs, transporters, importers, warehouses


Quality Systems (30%):

  • Assistance for the compliant state of the QMS specifically:
    • Document Management and Records Retention- All related SOPs, Work Instructions, Training and Veeva tool
    • Deviation, CAPA and Change Control ? All related SOPs, Work Instructions, Training and Veeva tool
    • Audit program ? SOPs, schedules, vendor credentials, contracts
    • Training program- assist in curriculum assignment, running training KPI reports.
  • Assistance for Computerized System Validation Compliance
    • Provide QA review and approval of validation associated with ALL GxP computer related system
    • Audit Computer Systems vendors for compliance to GAMP and Part 11/Annex 11 and data integrity
  • Performing analysis, creating reports, and supplying metrics to meet Stakeholder requirements


Requirements:

What will make you successful for this position:

  • B.S. degree in a scientific discipline or equivalent experience
  • Minimum of 5 years of hands-on experience in a Pharmaceutical or Biotechnology company
  • Comprehensive working kledge of local, state, federal, and international regulations and industry practices pertaining to GMP, GDP, ICH guidelines
  • Could have until 10% of travels
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point
  • Excellent cross-functional stakeholder management skills