Position: Mid-Senior level

Job type: Full-time

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Job content

Our client is a biopharmaceutical companyMain responsibilities :
  • Responsible for Quality Oversight with follow up on deviations, investigations, CAPA handling, Change Management and Periodic Review related to computerized and automated systems as well as data integrity events. As a SME, this role supports or executes investigations, root cause analyses and CAPA definition as needed and appropriate.
  • Handles qualification and validation documentation for QA review of relevant documents / reports (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) and supports execution.
  • Participates on project leadership teams for the development and integration of business applications including but not limited LIMS, MES, SAP, OSI-PI. Provides clear communication to his manager on the overall compliance of the projects.
  • Responsible for leading, reviewing and approving data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements. Use and further develop Data Integrity checklists to assess all (laboratory or manufacturing) processes and systems.
  • Writes new, revises and makes recommendations for SOP and quality documents for Quality department and supported departments of the manufacturing site.
  • Supports the design of Master Batch Records for bulk or packaged commercial drug products.
  • Handles in cooperation with partners for GMP activities.
  • Provide collaborative support and Quality oversight regarding computerized and automated systems validation requirements.
  • Provides support and guidance to other departments and functions for Data Integrity topics.
  • Supports the internal GMP-audits process including the yearly internal audit plans, the writing of audits reports (paper or electronically) and the follow up and the implementation of the internal audit CAPAs.
  • Ensures successful Authorities inspections by participating in the preparation and the support in different roles (i.e. Backoffice, Subject Matter Expert, Scribe or Runner).
Your Profile
  • Minimum 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry, preferably with related computer systems validation and project management experience.
  • BSc/BA or MSc in Science or relevant discipline.
  • Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
  • Strong knowledge of current Good Manufacturing Practices (cGMPs), Good Automated Manufacturing Practice (GAMP), Food and Drug Administration (FDA), and other regulatory requirements.
  • Knowledge in the use of business, scientific and personal computer software and hardware, system security data collection hardware, operating systems and application software.
  • Strong system and process insight: impact and consequences on compliance, operations and cross-functional areas.
  • Excellent interpersonal collaborative, organizational and training skills.
  • Excellent team player attitude.
  • Ability to manage various projects in a stressful and a moving environment, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team.
  • Works independently, yet effectively in a team environment, makes proposals and facilitate decision when escalation is needed.
  • Excellent written & oral communication skills in both French and English.
  • Excellent investigational skills and QA problem solving skills.
  • Ability to focus attention to details and to handle multiple tasks while working against pressures of deadlines.
  • Sense of responsibility, reliability, team spirit, initiative and service.
  • Knowledge of most common office software.
#boost permanent position
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Deadline: 18-04-2024

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