Microbiological Quality Control Manager

Summary

The Micro QC Manager ensures that Biological and Microbiological Quality Control processes for materials acceptance, environmental checks, batches quality control and related equipment validation/qualification are executed and fully compliant to cGMPs regulation, corporate and national guidelines.

Responsibilities

• Support the preparation for and execution of internal and Health Authorities inspections.
• Approve or discard raw materials used for manufacturing of products and all semi-finished products and finished products.
• Immediately notify any substantial irregularity detected in the product that has already been placed on the market.
• Support technological and organizational interventions aimed at the improvement of manufacturing processes in terms of quality, productivity and costs and the optimization of the resources relating to the site.
• Support the development and implementation of projects related to new or existing products.
• Ensure the compliance with the rules of hygiene and safety and protection according to cogent law.
• Monitoring the stability trend of the products.
• Approve/verify the Quality Control Documentation (specifications, sampling and control methods, procedures) related the belonging area.
• Guarantee, for its own area of competence, that every equipment used is correctly qualified and under instrument lifecycle control.
• Guarantee, for its own area of competence, that the analytical methods are correctly validated and under analytical method lifecycle control.

Essential Requirements

• Degree in Biology, Microbiology or Biotechnology.
• Previous experience in managing a team of people within a Microbiology laboratory.
• Excellent organizational skills (time management, risk management) including attention to detail and multitasking skills.
• Fluent in Italian and English.

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