Regulatory Compliance Officer - 2 years contract (BBBH427717) Nyon, Suisse
Kelly Scientific is looking for a Regulatory Compliance Officer for its partner GSK – 2 years contract.
Regulatory Compliance Officer – 2 years contract
RESPONSABILITIES
- Act as point of contact with plant and collaborate with worldwide affiliates for regulatory compliance matters
- Approve new product launches, BOM switches, packaging changes and implement in production as well as release systems
- Verify accuracy of documentation and variations packages provided to local affiliates/HAs and follow up on variation status including completion of change controls records to ensure timely implementation
- Participate in change control process from creation, strategy and implementation until closure
- Verify regulatory compliance of locally registered dossiers vs global dossiers and plant practices
- Write, review and approve technical documents in English in appropriate format (CTD format). Review and approve stability protocols.
- Identify and evaluate gaps as well as propose regulatory remediation and get escalation process under way in case of non-compliance, provide support during audits and Health Authorities Inspections
- Propose simplification processes and elaborate SOP and WI for all processes related to team activities and daily tasks
- Evaluate Regulatory Compliance resources for projects and report KPIs
- Provide support on TTS/QAA preparation and review
PROFILE
- 3-5+ years in a Pharmaceutical Quality Environment
- Good experience in Regulatory Affairs/CMC
- Understanding of laboratory techniques
- Overall lifecycle of pharmaceutical products
- Good understanding of GMP
- French and English fluent
YOUR KELLY CONTACT
Mrs Charline Maire
Consultant Professional Staffing Life Science
Kelly Scientific Geneva