Aseptic Process Simulation Specialist - Monza, Italia - Thermo Fisher Scientific

Thermo Fisher Scientific

Azienda verificata

Monza, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

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;
Onthefloor 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 12 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.