Microbiology Laboratory / Technology Lead
Visualizza: 171
Giorno di aggiornamento: 29-03-2024
Località: Saint-Prex Vaud VD
Categoria: R & D IT - Software
Industria: Medical Equipment Manufacturing Research Services Pharmaceutical Manufacturing
Tipo di lavoro: Full-time
Contenuto del lavoro
Job Description:
Mission:
The Microbiology Laboratory Head will ensure the compliance of the Ferring St-Prex Pilot Plant to the practices and requirements for sterile IMP manufacturing, reporting to the Plant Director and performing GMP duties for the Quality Control Head. He/She will act as Subject Matter Expert (SME) for the Center of Expertise (CoE) Analytics, reporting to the CoE Analytics Director. In this role, he/she will ensure benchmarking vs industry practice in his/her field and will drive microbiological innovation deployment in the Ferring QC Sites.
Your main responsibilities:
- Establish the microbiological quality system for St-Prex Pilot Plant, and train staff on relevant requirements
- Manage the microbiological analytical lab in St-Prex Pilot Plant for the production of sterile IMPs
- Manage CAPAs, deviations, and environmental monitoring (EM) trends
- Participate to Health Authority inspections
- Operate in full compliance with Health Safety and Environment System and proactively contributes to improving it
- Support the manufacturing sites through CoE Analytics as Microbiology Technology Lead by:
- Acting as a SME for all microbiological queries
- Benchmarking with industry standards in the microbiological field, through the active participation to Expert forums.
- Establishing and Leading the Ferring Microbiology Network among experts from the different Ferring QC Sites.
- Leading the deployment of innovative microbiological methods (including Rapid Micro Methods) in the Ferring QC sites
Required experience and competences:
- Degree in Pharmacy, Biology or Biological Chemistry
- 7 to 10 years’ experience in microbiology in the pharmaceutical industry, with demonstrated project execution experience
- Mastering of microbiological requirements applied to a sterile IMP manufacturing facility
- Deep understanding of cGMPs, FDA preferred
- Good knowledge of various types pharmaceutical dosage form, e.g. solids, liquids, proteins and peptides
- Good command of English (verbal & written)
- Good communication (both written/verbal) and listening skills; and ability to persuade others by using evidence (facts and figures) to justify arguments
- Good influencing skills
- Ability to lead a group of microbiology experts (Microbiology Network)
- Ability to represent the business to the customer/external stakeholders
- Ability to work well as an integral part of a large Project Team, a team player, task oriented and keen on working in a cross-cultural working environment towards set objectives
Location:Switzerland HQ - St-Prex
Scadenza: 13-05-2024
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