QUALITY CONTROL EXPERT - MICROBIOLOGY
Descrizione dell'offerta di lavoro
Their responsibilities range from conducting tests and maintaining equipment to recording activities, collaborating with stakeholders, and ensuring compliance with quality standards.
Strong technical skills, attention to detail, and adherence to regulatory requirements are essential for success in this role.
Your key responsibilities.
Your responsibilities include, but are not limited to:• Perform microbiological testing according to established protocols, including sample preparation, plating, incubation, and reading of monitoring plates.• Arrange plate identification as per procedure, collaborating with external labs when necessary.• Escalate any issues related to EM monitoring to the appropriate personnel.• Verify the correct functionality of micro lab equipment and perform routine cleaning.• Record all activities accurately and in compliance with SOPs.• Keep the collection of EM data up to date to generate Aseptic and Micro Key Performance Indicators (KPIs).• Perform, support, and supervise aseptic/EM analysis, ensuring compliance with internal SOPs and ALCOA+ principles.• Provide adequate training for delegated sampling, new hires, or external personnel involved in microbiological activities.• Collaborate on investigations to assess the impact of microbiologically linked events on product safety.• Implement corrective and preventive actions to ensure proper flow and timely resolution of issues.• Report any deviations or out-of-specification findings promptly to the Quality Control Manager and QC Microbiological Lead.• Support maintenance and qualification activities of quality control equipment.
Conduct instrument performance qualification tests as required.• Collaborate with management to achieve department objectives.• Maintain good conditions of laboratories, instruments, and work environment.• Keep quality control SOPs updated in collaboration with the team.• Perform EM microbiological trend analysis to identify patterns and potential areas for improvement.• Capture internal changes through Change Controls to ensure proper documentation and compliance.• Maintain and update spreadsheets to track data and results accurately.• Ensure the correctness and compliance of QC SOPs with Pharmacopoeias and regulatory requirements.• Adhere to required Health, Safety, and Environmental (HSE) standards and proactively address safety concerns.• Maintained documentation related to Environmental monitoring activities up-to-date.
Dettagli dell'offerta
- Imprecisato
- Tutta l'Italia
- Imprecisato - Imprecisato
- 29/03/2024
- 27/06/2024
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