GCP/GLP Quality Audit Report Processor-Contract

24 May 2024

Vacancy expired!

Latham BioPharm Group, a part of Sia Partners, provides the insight, knowledge, and network to unite teams and technologies in the Life Sciences. We provide the depth of expertise necessary to advance programs, by providing a range of life science services including business development, program management, CMC, non-clinical, quality, regulatory, and strategic consulting with proven experience in biodefense/pandemic response and strategic product development.Project Length: 9 MonthsLocation: Remote, Boston, MA preferredResponsibilities:Supporting the execution of the QA Master Audit plan ensuring the conduct of GCP, GCLP, GLP related audits.  These audits could include investigator site audits, service provider audits, computer system validation audits, document audits and internal system/process audits.  The oversight will span from scheduling of audits through closure of audits. Schedule AuditsDetermine AuditorContact AuditeeCompare and Review datesIntroduce Auditor to AuditeeKick-Off Meeting scheduled with individuals identified by auditor and audit leadCreate new Audit in Veeva VaultSchedules Audit Debrief meeting scheduled individuals identified by auditor and audit leadTracks audit report due datesTracks audit report response due datesProvides high level review of CAPA responses – sends to audit lead for approvalTracks audit closure – after auditee responses completed and acceptable.

  • ID: #49987117
  • State: Maryland Elkridge 21075 Elkridge USA
  • City: Elkridge
  • Salary: USD TBD TBD
  • Job type: Contract
  • Showed: 2023-05-24
  • Deadline: 2023-07-23
  • Category: Et cetera