Quality Control Expert

5 mesi fa

Colleretto Giacosa, Italia Novartis A tempo pieno

395267BR

**Quality Control Expert - Microbiology**:
Italy

**AAA Statement**

**Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.**
**Advanced Accelerator Applications offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).**

**About the role**

The Quality Control Microbiological Technician plays a crucial role in ensuring the safety and quality
of products through microbiological testing and analysis. 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.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

**What you’ll bring to the role**:

- Scientific Degree: Microbiology, Biology, Biotechnology or Pharmacy preferred.
- At least 3 years of experience within the QC microbiology department of a pharmaceutical company and knowledge of aseptic techniques.
- Fluent in Italian and good knowledge of English.

Work location: Colleretto Giacosa (TO).

**Division**

Oncology

**Business Unit**

ADVANCED ACCELERATOR APPLICATIONS

**Work Location**

Colleretto Giacosa

**Company/Legal Entity**

AAA Italy Srl.

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes

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