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
