Job Detail

Introduction

ALTEN, the European leader in engineering and technology consulting, provides support for its clients’ development strategies in the fields of innovation, R&D and it systems. Its 28.000 top engineers carry out studies and conception projects for the technical and information systems divisions of large corporate clients in the industrial, telecommunications and services sectors. In a fast globalising world, ALTEN integrates with the R&D strategy of its clients to support performance and partner them in breaking into new markets. ALTEN is active in 20 countries, covers the whole development cycle and offers a choice of service levels, from technology consulting to full-blown project outsourcing. It is the technology partner of choice for Europe’s leading companies.

The International Talent Acquisition Department is now looking for Manufacturing Experts and a Manufacturing Leader to join our team in the Life and Science Industry in the German speaking part of Switzerland.

We are looking forward to getting to know you and your ambitions!

Responsibilities

• Responsible for the independent planning and supervision of clinical supply in adherence with GMP requirements and project timelines 


• Delivers GMP compliant documentation and supports worldwide registration processes 


• Provides front line support for manufacturing, focusing on manufacturing processes and executing each batch safely and on time, in compliance with the batch instructions and quality requirements 


• Drives process related trouble shooting, leads product and process related investigations and deviations, including complaints actions 


• Ensures that process technical batches generate sufficient process knowledge by thoroughly testing critical variables 


• Maintains their processes at inspection readiness level and provides the necessary support in any internal or external audit 


• Ensures that all critical and significant parameters are within written instruction (i.e. Master Batch Record, Validation Plan) 


• Supports the execution of process validations, re-validations and short-term improvement projects

Skills

• MSc. or PhD in Pharmacy, Chemistry, Biochemistry, or Biotechnology


• 1-8 years of industry experience in dosage forms development and/or GMP manufacturing of dosage forms 


• Profound understanding of regulatory and cGMP requirements as well as expertise in the development of drug delivery systems 


• Fluent in German and English