- Our company is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services.
- All our company’s services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes.
- We are now seeking a MICROBIOLOGY PROJECTS SUPPORT to incorporate the laboratory of our partner you will join our R&D team supervised by our manager to ensure the following responsibilities:
- Define, implement and monitor actions needed to develop the product (project for a new product or an existing product on the market following modification (s) requiring documentary trace-ability), from the perspective of the microbiology.
- Write and compile the documentation associated with the product dossier
So, your missions will be:
- To be the contact person of our partner in the function assigned
- Represent the relevant function within the project team for all associated communications
- Determine the necessary actions to support the development of new products or accept the changes on existing products, according to the relevant regulations, the pertinent guidelines and customer guidelines.
- Conduct or arrange the realization by internal or external partners, testing / trials / prototypes / samples / labeling for the project and monitor progress.
- Analyze test reports and assess the acceptability of results
- Provide technical expertise in the validation of data inherent in the project and submit them to the project team
- Write and check the documentation necessary to compile the product dossier and communicate information to other departments and the necessary samples if needed
- Participate in investigations to solve technical challenges that impact for microbiology (out of specification, out trend,).
- Participate in the drafting of documents associated with these investigations
- Participate in Quality assurance Laboratory (procedures, equipment tracking, for example) if relevant
- Update internal working databases and documents and / or external
- Update as often as possible, the internal and external tools to monitor activities
- Education: Master degree in microbiology / cell biology
- Experience: 3 years minimum of work experience in the pharmaceutical and / or cosmetic support for the development / validation of methods and / or development of finished products
- Confirmed competencies of development / validation / transfer of methods, definition and follow-up of stability tests ideally in cosmetics and / or pharmaceuticals
- Confirmed practice of managing a multi-project portfolio simultaneously
- Confirmed practice of exchanges with suppliers / subcontractors / multidisciplinary project team
- Confirmed editorial skills (specifications, reports)
- You are used to work in a multidisciplinary team and have great organizational skills.
- You are recognized for your proactivity and your assertiveness.
- Fluent English/ French you will have daily contacts with people abroad
- Competitive salary package
- Training and development
- International and growing company
- Dynamic environment