Description
“Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo. Come and join us to create a future where disease is a thing of the past. Janssen Schaffhausen Site/Cilag AG is a Launch site for new products with focus on Parenteral Products (e.g., Prefilled Syringes and vials).
The QC Microbiology Department is looking for an engaged person as Supervisor/Lab Lead starting as soon as possible
Lab Lead / Supervisor (f/m/d)
Utilities Monitoring (QC Microbiology)
Main Responsibilities
- Leading a team of about 10 persons
- Interdisciplinary coordination of projects (e.g., Engineering, Pharmaproduction, Microbiology, QA)
- Optimization and continuous improvement of our documentation and Labsystems in order to avoid Quality Issues
- Responsibility regarding water sample analysis; Lab coordination and management
- Support of projects e.g., completion of CAPAs
- Support regarding budget planning of the own area of responsibility
- Processing and organization of routine activities independently as well as performing trainings of the team members
- Support with the generation of trend reports and their microbial assessment
- Processing of Quality Issues and definition of correcting measures
- Presentation of own area of responsibilities during audits and inspections
- Being contact regarding microbial monitoring of utilities with other functions
- Coordination and processing of projects independently
- Support the establishment of microbial test-protocols in eLIMS
- Coordination of the microbial sampling in order to qualify utilities and classified rooms
- Preparation of GMP documents i.e., qualification, trend reports, SOPs
- Comply with GMP regulations
- Work according to cGMP, J&J internal procedures (SOPs) and external regulations
Qualifications
You are familiar with microbiologic topics, and you are tech-savvy. You have an analytical thinking, you work in structured way, you like working in a team and your communication skills are very good.
Further needed qualifications:
- University degree (PhD) in Biology with the focus on Microbiology, Food technology or adequate studies
- Ideally you have professional experience in the Quality Control Microbiology or Quality Assurance, in Environmental or Utilities monitoring and/or in Fill Finish
- Knowledge of the EU-, FDA-, cGMP- and cGLP- regulatories are beneficial
- Business fluent German and English
- Initiative, to foster improvement projects
- Strong knowledge in MS Office