QA Admin (Chemical)

Main Responsibilities

Manage and Update System Records

• Ensure Org to be up-to-date in the system every month
• Training compliance report - Issue report by groups and produce summary
• SOP report - 100% site SOP compliance
• Issue SOP report / reminder to owners
• Assign training, trouble shooting, archiving.
• Issue open record report
• CaPA/investigation on time every month.

Quality Tracking

• Maintain Validation and ensure 100% completion
• Issue report and reminder to owner for open validation
• Maintain OOS Tracker and track all OOS to be closed with investigation/actions
• Reminder to open action owner, remind to OOS.
• Condition Audit
• Ensure 100% closure of CaPA development/closure Reminder to open action owner

Quality Audit Support

• Quality Audit worksheet consolidation
• Consolidate each worksheets to one master sheet
• Audit observation input
• Correct inputs into system
• Transfer the observation to system
• Coordinate Quality Audit mtg

Consumer Complaint

• Investigator Role and Simple data pull/analysis System log in and coordination with BU owners to close investigation on time
• Perform brand wellness (compliance) reviews by comparing plant documents, technical standards and regulatory guidelines to identify issues and provide recommendations
• Reach out to plants/suppliers to help compile information required for dossier writing
• Support writing of dossier sections for Module 3 (Quality documents)
• Track closure of revisions required post brand wellness review. Confirm required revisions are completed before handover of documents to regulatory team for external submission.
• Support review of Plant Quality Review reports.
• Support maintenance of the stability data library. Ensure data is available in correct format for statistical analysis.
• Support occasional, basic lab-work for formulation development.
• Support creation of technical standards and tracking for review/approval completion, for Brand Wellness-related remediations