QA Consultant (FDA Compliance)

Gi Life Science is looking for its partner 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 ([email protected])

Consultant Life Sciences, Professional Staffing

Gi Life Sciences Geneva

Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world.

In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton, BauTech and former Kelly Services. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services.

With a direct presence in 35 locations across Switzerland and over 250 employees, we are one of the leading staffing companies in the Swiss recruitment market.

Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions.

We believe in experts talking to experts : all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360 .

Branche : Wissenschaften

Funktion : Produktion

Anstellungsart : Temporäre Arbeit