QA Officer - Pharma

Approve SKU, BoM and Process Order of SFP and FG

Issue, check and arrange batch record, analytical sheet

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

Manage deviation and ILI: Investigate and follow deviation and ILI related RMs and assigned product

Prepare data for annual product quality review (PQR) for assigned product, follow up the performance of CAPAs

Tracking progress implementing of the corrective and preventive action related to quality to ensure appropriate and timely improvements

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

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

Manage FG complaint, RM and PM complaint

Responsibility of Administrator for assigned equipment, system and performed assigned periodic audit trail

Document management including archivement of document

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

Report to the appropriate management the cases not complied with the standards, with the GxP requirements and regulations

Support other activities of department when necessary

Strictly follow and remind colleague to follow the HSE requirement

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

Fluent in English (4 skills)