192 days ago on jobs.kellyservices.ch

Regulatory Compliance Officer _ Temp position 18 months

Kelly Services (Schweiz) AG

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Regulatory Compliance Officer _ Temp position 18 months

Kelly Scientific is looking for a Regulatory Compliance Officer _ Temp position 18 months

Job Purpose
The main objective is to verify regulatory compliance of locally registered dossiers against current practices in the plant. Evaluate any gaps; propose strategy and follow up on submission and implementation.

Key Responsibilities

  • Compliance / Technical writing:
  • Verify regulatory compliance of registered dossiers
  • Evaluate gaps
  • Propose regulatory remediation strategy
  • Manage corrective actions that are being put in place
  • Prepare necessary change controls for variations
  • Write technical documents to be included in or related to regulatory dossiers and manage approval workflow
  • Manage requests for modification and creation of new documents
  • Follow up on comprehensiveness and quality of feedback received from countries
  • Coordinate answers to questions from local HAs
  • Get escalation process under way in case of non-compliance
  • Security :
    • Apply and support company HSE requirements
    • Anticipate change consequences on health, security and environment
  • GMP :
    • Enforce and drive GMP standards
    • Maintain and approve local procedures related to the activity
    • Ensure that the state of Change Controls records reflects the current situation and are in full compliance with company requirements QM N3.13 “Change Control”
    • GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system
  • Administration :
    • Ensure the progress of the records and report periodically their states
  • Communication :
    • Communicate with ease with internal departments and with local affiliates
  • Continuous Improvement:
    • Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work

Key interactions :

  • Plant : QC, Analytical Services, Compliance & Auditing
  • Global and local Regulatory Affairs

Knowledge/ Education / Previous Experience Required

Educational Background
Bachelor in Life Sciences with proficiency in English
Job-Related Experience

  • 3-5 years’ experience in a Pharmaceutical Quality Environment.
  • Driven for accurate and detailed results, while exercising good judgement.
  • Striving for continuous Improvement in the systems and processes supporting regulatory compliance
  • French : fluent (oral and written)
  • English : fluent (oral and written)
  • MS Office : good command
  • Strong abilities for technical writing in English

Kelly Services (Suisse) SA
Kelly Scientific Resources
Mme DROMARD Mathilde, Consultant Professional Staffing Life Science | PhD in Biology and Health |
Rue du Rhône 114, 1204 Genève, Switzerland