Level of experience:
Life Sciences & Chemicals
is a uniquely positioned that bridges the gap between Strategy and Operations by aligning Business, Technology and Management. We bring our clients' ideas and projects to life through a profound understanding of strategic business benefits, and then accelerate their performance with a pragmatic hands-on mindset and approach.
Avertim was founded in 2007 and has grown to 280 consultants advising clients on their major challenges in several European countries. In the Life Sciences Business Unit, Avertim’s consultants work together with international market leaders to advise them and support project execution in the areas of Quality & Compliance Management, Manufacturing & Supply Chain Management, Clinical R&D, Regulatory Affairs etc.
As a senior consultant in Life Sciences, you will get involved in different client projects in the area of Quality and Compliance. Depending on the project you may have following responsibilities:
- Support pharma and medtech companies during internal and external audits and inspections as well as FDA submissions
- Analyse current Quality processes and systems in highly regulated environment (GxP, ISO, MDA, etc.), define performance metrics and drive continuous improvements
- Review records, SOPs, investigate deviations or non-conformities, handle CAPAs and Change Control Processes
- Lead or participate to qualification and validation activities, review technical documentation
- Perform gap assessments, risk assessments and root cause analyses
- Strengthen Quality maturity & mindset through better change management, communication, documentation and training practices
- Coach and train your peers on a specific subject matter
- Possibly take over team management at interim roles at the client
- A graduate degree in a relevant Life Scieces field( e.g. Biology, Biochemistry, (Bio-Engineering, Pharmacy, Medical Sciences etc.)
- Confirmed experience in a quality-related area in the Life Sciences
- Fluent in German and English
- Excellent communicator both orally and in written expression
- Knowledge of Project Management methodology experience or certification is a plus
- Knowledge of GxP / validation / qualification is a plus
- Be part of a network of
- Be part of a winning team and a company with a competitive compensation package and solid benefits
- and skills as Sr Consultant and be
- Be based in Rhein-Main area with the of home office day
Interested in this challenging position? Apply now!