KEY RESPONSIBILITIES:

· Drive harmonization process and create digital drafts for methods that are currently performed on paper worksheets.

· Create and update Method execution templates in the LIMS system.

· Support change-control impact assessments (when required)

· Contribute to the design of master data for use in digital methods.

· Coordinate validation of master data.

· Create/update the technical documents as per Standardization (Harmonization) Process.

· Manage updates to existing digital methods.

· Provide training to operators on the newly deployed methods.

· Act as the contact point for the lab in case of questions.

· Assist in the setup and validation of LIMS - instrument interfaces.

REQUIREMENTS:

· A minimum of a Bachelors degree or equivalent in Chemical / Life Science required. An advanced degree preferred.

· 5+ years of related experience including at least one of the following: Quality Assurance, Quality Control, Analytical Testing, or IT, including experience working in pharmaceutical (preferably in Synthetic molecule) or other highly regulated industry.

· Experience with HPLC, Dissolution and NIR is considered a plus.

· Proven experience with digital lab systems like LIMS (preferably Labvantage), with key user or business admin roles being advantageous.

· Experience with connecting Instrument with LIMS is considered a plus.

· Experience in participating in process improvement projects.

· Strong communication and presentation skills.

La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad.it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).