QA Document Controller

Job description for QA Document Controller at Beacons Pharmaceuticals Pte Ltd

Beacons Pharmaceuticals is celebrating 40 years of continued success, having been established in 1970 as Singapore’s largest manufacturer of generic pharmaceuticals. We provide a comprehensive suite of fully integrated one-stop contract manufacturing solutions and are now seeking a dedicated QA Document Controller to join our growing team. This role offers an exciting opportunity for professionals who value precision and compliance to contribute to a legacy of quality and innovation within a dynamic and supportive work environment located at 2 Second Chin Bee Rd, Singapore 618769, Singapore.

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
• 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.
• Batch Release
• Monitor finished goods inventory and coordinate with Production and/or Sales personnel to assure supply chain of products.