QC Micro Lab Lead
As the Head of the Microbiology Laboratory, you will be responsible for managing and developing personnel and microbiological processes of the laboratory, for the smooth implementation of control activities with the aim of servicing customers, in accordance with legislation, internal regulations, good practices and business goals.
Your key responsibilities:
Main responsibilities:
Strategic management and development of the Microbiology Laboratory in order to ensure smooth operation and full compliance with the requirements of the cGxP regulation.
Supervision and coordination of microbiological testing of raw materials, intermediate products (IPCs), active substances and environmental samples, in accordance with all safety, quality and regulatory standards.
Ensuring compliance with Good Laboratory Practices (GLP) and carrying out activities in accordance with national legislation, European guidelines, FDA and other relevant regulatory bodies. Active support in internal and external audits and inspections.
Managing investigations of deviations, OOX results and complaints, as well as participating in the design and implementation of corrective and preventive measures (CAPA).
Fostering a culture of continuous improvement and operational excellence within the microbiology department.
Management of training and professional development of team members in accordance with the requirements of cGxP; performance monitoring and competence assurance.
Providing expert support to microbiological quality control, production and regulatory matters, including the preparation and submission of documentation.
Coordination of the operational activities of the department and provision of professional microbiological support for production processes and regulatory requirements.
Your contribution to the workplace:
A university degree in microbiology, pharmacy, biotechnology, or a related field.
Minimum of 3 years of work experience in the field of laboratory processes or in a similar position.
Experience in the field of microbiology in the pharmaceutical industry, with a good knowledge of cGxP and GLP.
Leadership experience and ability to develop a team.
Excellent understanding of regulatory requirements (EU, FDA) and experience with inspections and audits.
Analytical skills, proactivity and problem-solving orientation.
Very good knowledge of English (written and oral).