Quality Control Microbiology Manager
hace 3 meses
MLF-2407-254
QUALITY CONTROL MICROBIOLOGY MANAGER
VALENCIA
Job Offer:
International company belonging to the pharmaceutical industry, is looking for an QC Microbiology Manager for their plant located in Valencia. The Manager, QC Microbiology is responsible for leading and managing the Microbiology Quality Control (QC) laboratory, ensuring compliance with regulatory requirements, and supporting the overall quality objectives of the company. This role involves overseeing microbiological testing, developing and implementing quality control strategies, and managing a team of microbiologists.
Key Responsibilities:
Team Leadership:
Manage and develop a team of microbiologists, providing guidance, training, and mentorship.
Assign and oversee daily responsibilities, ensuring efficient workflow and resource allocation.
Foster a positive and collaborative work environment.
Quality Control:
Develop, implement, and maintain QC microbiology procedures and protocols in accordance with cGMP and regulatory requirements.
Oversee environmental monitoring, sterility testing, bioburden testing, and other microbiological assays.
Investigate and resolve microbiological deviations and out-of-specification results.
Implement corrective and preventive actions (CAPA) to prevent recurrence of quality issues.
Laboratory Management:
Manage laboratory resources, including equipment, supplies, and reagents.
Ensure laboratory compliance with safety, environmental, and quality standards.
Coordinate equipment calibration, maintenance, and qualification.
Regulatory Compliance:
Stay updated on relevant regulations and industry standards (e.g., FDA, EMA, ISO).
Ensure compliance with quality management systems (QMS) and internal procedures.
Prepare and review documentation related to quality control activities.
Support regulatory inspections and audits.
Process Improvement:
Identify opportunities for process improvement within the QC microbiology laboratory.
Implement new technologies and methodologies to enhance efficiency and accuracy.
Participate in cross-functional teams to address quality-related issues.
Requirements
Master's degree in Microbiology or related field.
Minimum of 5 years of experience in a QC microbiology role within the biotechnology or pharmaceutical industry.
Proven experience in managing and developing a team.
Strong knowledge of microbiological techniques and methodologies.
Expertise in GMP regulations and quality systems.
Excellent problem-solving and analytical skills.
Strong organizational and time management abilities.
Effective communication and interpersonal skills.
Experience with aseptic processing and sterile product testing.
Knowledge of statistical process control (SPC).
Experience with LIMS and other laboratory software.
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