Process Expert

1 mese fa

Modugno, Italia Randstad Italia Spa A tempo pieno

Functieomschrijving Randstad Italia spa is looking for a Process Expert (Process and Cleaning Validation).

Responsabilità In the context of a multinational Pharmaceutical Company undergoing Site development, a new building for aseptic filling is currently under validation to support the production of parenteral products. As part of the Manufacturing Science and Technology Fill and Finish department, you will participate in the validation of manufacturing processes or cleaning processes related to products transferred to the new production lines. You will be a member of the validation team which deals mainly with process changes and monitoring of current processes through establishing Process Control Strategy (PCS) and Continued Process Verification.

You will also be responsible for the preparation, execution, and reporting of documentation related to process and cleaning validation. This project function will give you the opportunity to perform the changes from start to end. This role is an opportunity with large collaboration in several departments and multiple sites of the Company Network.

Functie-eisen YOUR PROFILE Education level: Pharmacist, CTF, Biotechnologist 1-3 years of experience in the validation topic Experience working with GMP Validation process and statistical knowledge; QbD approach is a plus English spoken and written fluently Product Tech Transfer knowledge Experience in Aseptic filling is a plus Regulatory knowledge is a plus The profile is completed by dynamism, organizational skills, good will, collaborative and team spirit, resourcefulness, and adaptability. Availability to work overtime and, if necessary, on holidays is required. Domicile in Bari and province required.

We offer an initial full-time contract for 6 months with possible subsequent confirmation.

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