The Sr. professional, document manage is accountable for dealing with and maintaining cGMP documentation procedures on a non-ordinary foundation, which includes initiation, issuance processing, routing, distribution, reconciliation, and archiving. This function includes issuing of logbooks, file evaluations, archival and developing and maintaining templates for neighborhood files while providing enter for worldwide documents. The expert serves because the number one factor of touch for the EDMS across the website online and network, providing guide for resolving complex troubles associated with the EDMS and other electronic documentation structures inclusive of electronic batch facts and ValGenesis.
duties
performs initiation, issuance processing, routing, distribution, reconciliation and archiving of cGMP documentation on a non-recurring foundation.
issues logbooks as requested from the EDMS.
Manages the periodic assessment program for site documents.
Creates and continues templates for local documents and offers input for international documents.
Serves as point of contact for the EDMS across site and community.
offers assist for the decision of complicated troubles associated with the EDMS and different electronic documentation systems (e.g., digital batch facts, ValGenesis).
performs gaps analysis to align nearby processes with global procedures and guidelines.
Identifies improvement possibilities and drives the execution of website/group non-stop development desires and projects.
support internal and external inspections as required.
may also gift man or woman topics throughout audits as wanted.
maintain compliance with assigned studying plan.
support development and delivery of education content to go practical groups.
support integration of more recent crew contributors and offer guidance and training to users of the EDMS, as required.
Lead meetings and represent function at cross useful and network conferences.
percentage facts/know-how within and across web page and network.
build & keep robust relationships with associate features.
Act as file manipulate SME to help with crowning glory of fine information as required including CAPAs, Deviations, and trade Controls.
requirements
Bachelor’s degree in STEM subject preferred.
high college degree/friends diploma with equal aggregate of education and paintings revel in may be considered.
4+ years of experience in document manipulate corporation/feature.
revel in in FDA/EMA guidelines in biopharmaceuticals or cellular remedy manufacturing is preferred.
tested revel in with pleasant management systems.
revel in with EDMS is needed.
📅 Jul 30 Posts (199)
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