Qc Micro Specialist Ii

5 mesi fa

Ferentino, Italia Thermo Fisher Scientific A tempo pieno

When you’re part of the team at Thermo Fisher Scientific, you’ll do important and strategic work: you will help customers in finding cures for cancer and several diseases, also rare pathologies, working on new and innovative molecules for strategic therapies and most as promising and innovative drugs for treatments for all patients, including children always pointing our attention to save lives and giving to many people big hope for a healthier future.

Your work will have real-world impact, and you’ll be supported in achieving your career goals

**Location**:
Ferentino, Italy

**How will you make an impact?**

The position is responsible to handling of microbiological validation activities through a powerful and efficient planning and progress control, to meet OTD/RFT (timely delivery / right first time) and client requests.

**What will you do?**
- Ensure the execution of Microbiological Methods Development and/or Methods Validation for assigned projects in compliance with current regulations (current EU GMP, US GMP) and company quality standards.
- Management/review of microbiological sampling plan/product and material specifications for sterile lyophilized and liquids drug products (vials, pre-filled cartridges or syringes).
- Draw up study protocols and reports for environmental monitoring.
- Ensures both the execution and the constant supervision of analytical laboratory activities for projects assigned in accordance with GMP requirements, supporting analysts and Scientists in problems solving.
- Manage customers with the aim of maintaining a high level of customer happiness and completing the required activities on schedule.
- Participates in calls/meetings with customers to support the discussion on technical topics for their area of expertise.
- Collaborates with the Supervisor/Team Leader to identify the requirements for microbiological method validation/information transfer from customers, then ensuring the accurate and effective handover to the laboratory.
- Collaborates in handling laboratory investigations (Out of Specification, CAPA and Deviation Reports).

**How will you get here?**

The education required for this role are degree in scientific area (Pharmacy / CTF / Biotechnology / Biological Sciences / Chemistry or similar technical field), PhD and/or PMP certification would be a nice to have.

2 years of experience in pharma/chemistry industry is required.

**Knowledge, Skills, Abilities**
- Knowledge of the main techniques of microbiological (Bioburden, Sterility and Endotoxins) and biochemical analysis and validation of analytical methods.
- Knowledge of GMP and national/international regulations.
- Knowledge of Sterile injectable drugs production processes.
- Fluent English
- Proficiency in Microsoft Office suite
- Broad and sound experience with Pharmaceutical Quality Systems (e.g Trackwise) and reporting tools.
- Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment.

This role requires a wide degree of flexibility, multitasking and open-minded demeanor with ability to prioritize multiple tasks and, problem solving demeanor and decision making along with influencing capacity, customer and result-orientation.

This is an equal opportunity employer: here in Thermo Fisher celebrates diversity and it is committed to crafting an inclusive environment for all employees

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