Senior QA Consultant (FDA Compliance)
Gi Group Life Science is looking for its partner in Nyon a:
SENIOR QA CONSULTANT (FDA COMPLIANCE)
Temporary position (1 year)
Your mission:
In this position, the QA Consultant will have to ensure overview and lead all the operational execution activities in the production area related to FDA remediation plan and inspection readiness. Furthermore, the QA Consultant will have to ensure that the products and bulk are produced in compliance with GMP requirements and both internal SOPs and regulatory approved documents, with a specific focus on US requirements. In parallel, the QA Consultant will have to coach and mentor all people in the Operations, to ensure compliance with US requirements on a day to day basis.
Your responsibilities:
- Coordinate all the activities and actions related to FDA remediation plan with a specific focus to the Operations
- Develop a Quality mindset to be prepared for FDA inspections at anytime
- Train the staff on how to prepare inspection and adopt right behaviors during inspections
- Ensure operations are compliant with internal standards (local and global procedures) and health authority expectations
- Ensure processes are efficient without compromise to quality of the finished product
- Liaise with the business partners and ensure cooperation and support with regards to efficiency programs within the value streams
- Appropriately manage escalations and ensure coordination of significant quality events having an impact on the FDA remediation plan
- Review and approve significant quality deviations within the Operations
- Ensure adequate assessment and timely closure of deviation events within production (deviations, CAPA).
- Respect all GxP standards, GxP knowledge and experience to support Health Authorities requirements
Your profile:
- Graduate qualification in a Pharmaceutical related subject
- 10 years’ experience in a Pharmaceutical environment, with at least 5 years in a management position
- Proven process understanding (Pharma, GMP, investigation and method development)
- Direct experience with production operations
- Experience with Manufacturing Site needs and constraints
- Experience in the continuous improvement process & Project management
- Experience with main GMP requirements (FDA, EMEA, Russia, …)
- Safety, Quality, Result and Customer oriented
- Excellent Communication skills, in English and French
- Well organized, pragmatic and able to define and support strategy
Your contact at Gi Group:
Marko Durakovic: 022 737 12 09
Consultant Life Sciences, Professional Staffing
Gi Group Life Sciences Geneva
Lieu de travail
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1260 Nyon
Contact
Marko Durakovic
+41 22 737 12 00
Write an email
Neuchâtel / Nyon
