QC Compliance Specialist

Overview

Expleo offers a unique range of integrated engineering, quality and strategic consulting services for digital transformation. At a time of unprecedented technological acceleration, we are the trusted partner of innovative companies. We help them develop a competitive edge and improve the daily lives of millions of people.

 

Joining Expleogroup means 19,000 employees in 30 countries, with a turnover of €1.4 billion, but also:

• Have technical and human support for each project and effective follow-up of your career
• Carry out training to develop professional skills
• Participate in dedicated special events
• Integrate a dynamic team

 

To support our growth in French part of Switzerland, Lausanne area, we are looking for a  Compliance QC specialist

 

Responsibilities

Your Mission :

• Support the QC team in their daily operations as an expert of compliance aspects for QC.
• Manage, investigate and close events and deviations in support of Subject Matter Experts in QC.
• Manage and support the timely and effective completion of deviations, non-conformances, investigations, change controls, and CAPAs; perform period reviews.
• Continuously improve data integrity (DI) knowledge base, including DI risk-analysis assessments and action plans, and periodically report status/progress to leadership team
• Support preparation of audits and interact directly with internal HCQ auditors and external regulatory agencies.
• Recommend and drive improvements to existing systems, processes, techniques or programs.
• Manage training plans of the team and support in ensuring training compliance.
• Collaborate with cross-functional teams, in particular act as Singe Point of Contact to QA, to address compliance issues and implement corrective actions.
• Provide training and guidance to staff on GxP regulations and best practices.

Qualifications

Your profile :

 

• Master Degree in Chemistry, Pharmacy, Biology, or Biotechnology.
• 5-7 years of experience with Quality Systems such as Deviation, CAPA, Change control in a pharma environment. 

• Strong knowledge of GLP/GMP/Quality System requirements and international guidelines (e.g. ICH, FDA, EMA) for biopharmaceuticals; knowledge of Data generation, Data processing, Data Quality principles.  

• Excellent investigational and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for issue resolution. 

• Previous direct experience in audits and interactions with health authorities. 

• Preferred hands-on experience with laboratory information systems, digital tools, automation technologies and lean principles. 
• FLUENT IN ENGLISH, French is an asset