QA Document Controller
-
Jurong West MRT, Jurong West
Beacons Pharmaceuticals, 2 Second Chin Bee Road, Singapore, 618769
- Sepenuh masa
- 5 Hari Seminggu
S$2200 - 3200 / sebulan
Job Descriptions:
a. 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.
b. 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.
c. To ensure proper documentation and filing based on good documentation practice.
d. To ensure that quality practices and international standards in operation such as GMP, GDP, ISO, PIC/S, etc. are adhered to.
e. Participate in and support all external audit where necessary.
f. To assist and ensure investigation completed and closure of the internal/external audit findings.
g. To perform other QC/QA activities assigned by Quality Manager
h. 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 documents prior 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 documentation systems.
· 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 assure supply 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 production and 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 QC approval.
· Attend a
Tentang Majikan
BRN/UEN: 197000900D
Kongsi ini dengan rakan anda
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