Elisabetta Corsi Email & Phone Number

QA/Process Validation Expert (DP, MD Vaccines, Biotech DP; mainly Liquid and Lyo Products in Vials)Quality Assurance (PQR, Change Controls, Complaints, Deviations, Inspections & Audits management, SOP, Quality Manual, GMP, CFR21, ISO 13485)

Anagni

• Organize and coordinate the activities needed for:
• the introduction of new Research/Development Products including Biothec Products and Vaccines (current role as Project Leader for Covidvax manufacturing process implementation),
• the transfer of products from/to Intercompany Sites or other Production Sites
• the production on behalf of Third Parties of drugs in clinical / development phase or already marketed;Support the introduction of new technologies, including Single Use… Show more Organize and coordinate the.
• the production on behalf of Third Parties of drugs in clinical / development phase or already marketed;Support the introduction of new technologies, including Single Use Systems and aseptic connections/disconnections.

Medical Device Quality Systems.Management of complaints for Medical Device (recording, investigation, quarterly reports and trend analysis).Support in the management of Drug Products Complaints.Inspection Readiness Focal Point for Internal Audits and Regulatory Inspections and Action Plans management.Good written and spoken English.Proficient in the use of.

Compilation of Product Quality Reviews/Annual Product Reviews.Support in the management of the Internal Procedure System and of the Analytical Method System.