Microbiological Quality Control Manager

Job Description 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.

 

Job Description

Major accountabilities:

• 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.

 

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management