QA Officer - Pharma

Manage logbooks and bookmarks: create new ones, make lists, periodically check and close logbooks and bookmarks of the product QA team. Check and close logbooks, bookmarks from assigned departments
Support other activities of department when necessary
Issue, check and arrange batch record, analytical sheet
Approve SKU, BoM and Process Order of SFP and FG
Strictly follow and remind colleague to follow the HSE requirement
Report to the appropriate management the cases not complied with the standards, with the GxP requirements and regulations
Tracking progress implementing of the corrective and preventive action related to quality to ensure appropriate and timely improvements
Manage deviation and ILI: Investigate and follow deviation and ILI related RMs and assigned product
Review batch manufacturing record and FP analysis record prior to the batch release decision of responsible or delegated person
Release the batch on system and extract FG CoA
Responsibility of Administrator for assigned equipment, system and performed assigned periodic audit trail
Document management including archivement of document
Prepare data for annual product quality review (PQR) for assigned product, follow up the performance of CAPAs
Perform qualification (qualification performance, process qualification performance, cleaning process, transportation validation and support to equipment qualification): prepare protocol, monitor, access and report the result, follow up the proposal from validation/qualification result
Participate GMP training activities
Manage FG complaint, RM and PM complaint
Manage the change control as assigned: make sure change control is approved before application, perform and follow up blocking works, make sure blocking works are replied before next step, follow close change control as monthly planning

Fluent in English (4 skills)
University graduated in Pharmacy, Chemistry or related fields
Open for candidates with at least 6 months of experience in a similar position, including internship
Basic knowledge in Lean and continuous improvement
Basic knowledge in GMP, HSE

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Cập nhật gần nhất lúc: 2025-09-08 14:20:02