Process & Master Data Governance Manager I (Onsite)
Aequor - Swiftwater, Pennsylvania, United States
Work at Aequor
Overview
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Overview
LabWare LIMS
specifically creation of product specs, sample plans and item codes. - Strong working knowledge of laboratory processes including cGMP’s in a pharmaceutical environment - Experience in system testing, validation, and master data management - Familiar with 21CFR part 11 data integrity best practices in pharmaceutical environment - Excellent written and verbal communications skills and the ability to lead and participate in teams - Experience or familiarity of the Laboratory Environment Position Responsibilities: - Ensure site on-time implementation of new iSHIFT system (ERP) activities through support of master data configuration and data migration and SOP revisions. - Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability and R&D operations - Provide first level diagnostic of incidents and support business users, IS LIMS Administrator and Support Center in the management and timely resolution of technical - Responsible for the master data management process including the updating of specifications and supporting the approval process - Manage Global System update and changes which may include new modules and workflow changes - Configure and Maintain instrument interfaces to Laboratory equipment - Ensure that the LIMS complies with all relevant regulatory standards - Support the business in the creation and updating of training materials as changes to system occur - Ensure that the LIMS complies with all relevant regulatory standards Technical competencies and soft skills: Working knowledge of aseptic processes, biology, chemistry, life sciences Knowledge of cGMPs and regulatory requirements with Strong analytical & balanced decision-making skills Good GMP documentation MINAKSHI SANGWAN Recruiting Lead - US Recruitment O 732-339-3518 W
http://www.aequor.com/ Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
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