QA Document Controller

Job Descriptions:

1. To create and /or review and update existing SOPs in accordance with international standards such as GMP, GDP, ISO, PIC/S, etc. including training of personnel where necessary.
2. To assist and develop, draft and review SOP’s (QSP, QGP, QAP, etc) and test procedure for QC routine and non-routine testing in accordance with the latest pharmacopeia.
3. To ensure proper documentation and filing based on good documentation practice.
4. To ensure that quality practices and international standards in operation such as GMP, GDP,ISO, PIC/S, etc. are adhered to.
5. Participate in and support all external audit where necessary.
6. To assist and ensure investigation completed and closure of the internal/external auditfindings.
7. To perform other QC/QA activities assigned by Quality Manager
8. Backup for the QA Executive

Documentation Compliance

1. Change Control
   - Administer and manage the Change Control System in QMS.
   - Review QMS documentation conforming to GMP standards and crosslinking of quality documentsprior to approval of document release.
   - Design and maintain SOP Master with up-to-date information.
   - Revise and develop SOP in-compliance to GMP for continuous improvement of documentationsystems.
   - Generate, monitor, and issue approved quality documents for use in day to day operations.
2. Batch Release
   - Monitor finished goods inventory and coordinate with Production and/or Sales personnel to assuresupply chain of products.
   - Assemble, review batch records promptly to evaluate product release compliance.
   - To assist in performing final review and release of finished product after ensures that all productionand quality activities are documented and reported in the batch records.
   - To assist in timely release of incoming raw material, packaging material for production use upon QCapproval.
   - Attend and resolve GDP discrepancies raised by relevant personnel.
   - Support the evaluation of deviation or OOS issues in manufacturing process.
   - Release the approved finished goods release for sales and distribution via Navision System.
   - Consolidate and trend testing results of Raw Materials and Finished Products.
3. Document Management
   - Manage and maintain the existing system for continuous efficiency and improvement.
   - Control and maintain the system for issuance, tracking, storing and retrieval of GMP documents toensure the documents are current, SOP compliant and easily accessible in both electronic and hardcopy.

- Archive inactive records and perform housekeeping in

accordance with the records retention schedule.

4. Operation Compliance

- Issuance of Certificate of Analysis (COA) upon request.

- Support in regulatory and audit as required.

- Support tender application by preparing documents and

coordinating Finished Products samples.