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Scientist, Analytical Science & Technology

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Maffioli Emplois & Cie
Scientist, Analytical Science & Technology

On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a Scientist, Analytical Science & Technology temporary for 7 months (extendable)

Vos tâches
  1. Purpose and Scope of Position

The Scientist is responsible for supporting the analytics of commercial products happening internally or at a vendor site. This support includes analytical data review, sample management, analytical release in collaboration with other quality functions, collaboration to method transfers, method improvement, remediation, method validation/verification and/or troubleshooting. Serves as a Subject Matter Expert interfacing with Regulatory Agencies and Analytical Vendors. The Scientist is responsible for investigations, CAPAs, change controls, when related to analytics of commercial products at all manufacturing sites, domestic, international and Vendors. The position requires proficiency working with sterile injectable biologic medicines. The knowledge of small molecule medicines in oral dosage and/or sterile injectables is an advantage.

  1. Duties and Responsibilities

Oversight of external Analytical Vendors from an analytical point of view as appropriate

  • Support the approval and qualification process
  • Review raw data (QC peer review)
  • Coordinate sample shipment between sites
  • Participate in the inspection/audit at Contract Service Providers
  • Provide support to Vendor during Health Authority inspections
  • Perform QC oversight of commercial Vendors as appropriate
  • Perform Analytical release as appropriate, issuing internal Certificates of Analysis and data conformity statements

Support laboratory investigations, deviations, CAPA's, Change Controls

  • Ability to troubleshoot method and/or equipment issues to the root cause
  • Capable of resolving non-routine laboratory issues and problems expeditiously
  • Interacts with Vendors, reviews raw data generated by Vendors during investigations and supports their lab investigations as needed
  • Ability to write analytical method risk assessments or regulatory impact assessment statements (RIAS)
  • Proposes meaningful, cost-effective CAPAs to address root causes
  • Able to raise Change Controls with the appropriate supporting data package
  • Participates in audits and interacts and answers questions from Heath Authorities

GQAST-related tasks

  • Support Validation of Analytical Methods or Tech transfer
  • Conceive experiments to evaluate analytical methods associated with commercial products for investigation, method improvement, remediation and/or troubleshooting.
  • Write formal analytical documents such as validation protocols, method transfer protocols and investigations reports.
Votre profil
  1. Required Competencies: Knowledge, Skills, and Abilities
    • Advanced knowledge and interpretation of cGMP
    • General understanding of analytical validation and technical transfer concepts and requirements
    • Advanced written and verbal communication skills
    • Strong problem-solving ability/mentality, technically adept and logical
    • Ability to interface with Regulatory Authorities and Contract Service Providers
    • Knowledge of international analytical regulatory requirements (PIC/S, USP, Ph.Eur, JP, FDA (21CFR Part 11, 210 and 211), Annex 11 (EU-GMP), ICH, and Good Automated Manufacturing Practice (GAMP)
    • Advanced knowledge of laboratory and aseptic processes
    • Ability to work independently, and/or lead and participate in team projects
    • Advanced knowledge of Microsoft Word, Outlook, and Excel, Project, and Visio
    • Requires presentation development and delivery skills
    • Ability to understand aseptic processes

Adresse

M. Dominique Bréa
+41 32 720 20 30
Grand-Rue 6
2000
Neuchâtel
https://www.maffioli.ch

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