Randstad Specialty Pharma, for a multinational company in the pharmaceutical field, we are looking for a Paperless Lab Design Lead.
The Paperless Lab Design Lead, you will be responsible for the deployment and maintenance of the digital lab system.
Work site: Latina
Contract situation: 6 months
Range RAL: 34k - 40k
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.