Process & Cleaning Validation Specialist Ii

2 mesi fa

Ferentino, Italia Thermo Fisher Scientific A tempo pieno

Draft of Validation Protocols (cleaning, Process, Media Fill), by acquiring information from other departments to define their contents (e.g. process parameters, sampling plan) as well as collaborating with company functions to define actions to be carried out, as per company procedures. Handle periodic cleaning validation and aseptic fillings (Media Fill). Ensure the drafting and/or updating of risk assessments for management of Cross Contamination.

Ensure accurate execution of validation activities, through the accurate collection and accurate analysis of the results generated

Draft the Validation Reports, based on the results emerging from the validation activities.
- Ensure the accurate archiving of all documentation

Provide quality support for the transfer of new products, through accurate participation in the various phases of the project up process performance qualification, assuring accurate GMP standards in force.

Actively participating as SME in all design, construction and implementation phases of new processes or manufacturing departments. Furthermore, depending on the needs of the Department and in accordance with the indications of the P&C Val Supervisor, he help the rest of the team (for example, APR).

**Education**:

- Completion of a Bachelor’s Degree or its equivalent (depending on country) in a scientific/pharmaceutical area (FCT, Pharmacy, Chemistry, Biotechnology)

**Technical skills**
- Pharmaceutical techniques
- Pharmaceutical production
- Aseptic Filling processes
- Risk management
- Client service/ Project Management experience
- Knowledge of Microsoft Office software (i.e. word, Excel)

**Professional Experience**:

- 2 years of previous related experience and a general knowledge of Pharmaceutical Industry experience.
- Equivalent combinations of education, training, and relevant work experience may be considered (i.e. Manufactruing Technology)

**Languages**:

- Italian as basice and English : Advanced written and oral communication skills

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