Requirements: English
Company: Avara Pharmaceutical Services
Region: Liscate , Lombardy
Purpose of the Role We are seeking after a proactiveand detail-oriented MS&T Specialist to support the seamlesstransfer of new manufacturing processes from other sites to ourfacility. This role will guide activities from pre-validationthrough process validation, including documentation for regulatorysubmissions. You will act as a key point of contact with clientsthroughout the transfer process and will also be responsible forcleaning validation of process equipment. Key Responsibilities -Lead all pre-validation activities for transferred products,including process review, water trials, machinability studies,placebo studies, and engineering runs. - Coordinate activities onthe production floor and interface with analytical labs to supportvalidation work. - Draft protocols and reports related topre-validation, process validation, and cleaning validationactivities. - Contribute to the preparation and review of theMaster Batch Record. - Work with sterilizing filter suppliers forfilter validation and review related documentation for regulatorysubmission. - Serve as the main client interface during the processtransfer and validation phases. - Conduct cleaning validation forequipment in direct and indirect contact with products. - Performcalculations for cleaning limits and support analytical labs incleaning method validation. - Collect field samples for cleaningvalidation testing. - Act as Subject Matter Expert (SME) duringclient and regulatory audits. - Required Qualifications -Bachelors or Masters degree in Biological Sciences, Chemistry,Pharmacy, CTF (Pharmaceutical Chemistry and Technology), orChemical Engineering. - Minimum of 2 years of experience in asimilar role within the pharmaceutical industry. Technical Skills -Solid understanding of GMP regulations and FDA requirements. -Experience with aseptic manufacturing processes. - Strong expertisein cleaning validation practices and documentation. Soft Skills -Strong analytical and problem-solving skills. - Excellentorganizational and planning abilities. - Effective communicationand leadership skills. - Fluent in English (written and spoken).This announcement is addressed to both sexes, in accordance withLaws 903/77 and 125/91, and to people of all ages andnationalities, in accordance with Legislative Decrees 215/03 and216/03. By applying to this announcement you authorize theprocessing of your personal data in accordance with Article 13Legislative Decree No. 196 of June 30, 2003 - Code on theProtection of Personal Data and Article 13 GDPR 679/16 - EuropeanRegulation on the Protection of Personal Data.