Aseptic Process Simulation Specialist Monza

Aseptic Process Simulation Specialist
Monza
Lombardia, Monza

The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind.

Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world.

When you join our team of quality professionals, you'll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

**Company overview

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue exceeding $40 billion and approximately 125, 000 employees globally.

Our mission is to enable our customers to make the world healthier, cleaner and safer.

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale.

Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.

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

**Location/Division Specific Information

Monza (MB)

**How will you make an impact?

The resource will become part of a lively and team with dynamic strengths which is responsible for the aseptic validation process of products' manufacturing in Monza site, by handling Aseptic Process Simulation (APS) documentation and supervising on the floor operations, in close contact with Client's technical and quality teams, and in accordance with Regulatory mentorship.

APS & Sterility specialist is a key element for the Company core business.

They cooperate with Project Managers, Process Engineers and Client technical teams, within Monza site Quality Unit.

**What will you do?

- Analysis of technical documentation related to new protocols;

- Issuing APS protocols and reports for, in accordance with GMP and corporate standards; Collect vital information by involving relevant functions.

Processes object of APS are: manufacturing of sterile lyophilized and liquids drug products (vials, pre-filled cartridges or syringes), as well as modern pharmaceutical technologies (i. e.

fill finish processes under isolators);

- Issue of manufacturing instructions (MBR) for APS batches;

- Issue of technical reports and risk assessments related to operator qualification, qualified holding times, aseptic interventions

- Ensure correct management and archiving of documentation in line with GMP and internal procedures;

- On-the-floor overlooking of manufacturing activities related to APS batches;

- Support in preparation and update of APS department SOPs.

- Ensure that all relevant activities are adequately evaluated and handled through change control management

- Support in preparation and participation to Clients' and Regulatory audits with regards to APS activities.

- Ensure that our client service delivery performance is maintained at the highest level, by building positive relationships with our clients and coordinating activities to ensure the clients are kept informed in a timely manner.

- Ensure an adequate reporting to the Area Management about potential issues

**How will you get here?

- Degree in Pharmacy / CTF / Biological Sciences / Chemistry / Industrial chemistry / Chemical engineering / Biotechnology

- At least 1-2 years of experience in pharma/chemistry industry

- Knowledge of sterile manufacturing processes and validation processes

**Knowledge, Skills, Abilities

- English and Italian proficient

- Knowledge of sterility assurance concepts

- Knowledge of pharmaceutical legislation and national/international laws

- Good communication skills, team working

- Propension to preparation of technical documentation

- Critical sensibility, attention to details, precision

- Organizational skills

**Interested?

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.