Job Description

Location Singapore, West

Planning Area
BOON LAY

Job Type
Permanent

Salary
$2,000 - $2,800 Per Month

Date Posted
1 day ago

Expiry Date
15-Aug-2022
Additional Details


Job ID
311744

Job Views
48

Roles & Responsibilities

• Manage the programme that generate and control critical documents such as batch sheets, standard operating procedures, quality specifications, quality procedures, analytical procedures, labels, certificates of analysis/conformance and protocols.
• Assist relevant personnel in the creation of Engineering Change Order (ECO), check the compliance of ECO documentation against established requirements, resolve issues with the change initiator and coordinate the release, distribution and retrieval of controlled documents with relevant functions.
• Ensure compliance of documentation control and change control processes with ISO13485, FDA 21 CFR Part 820/211, cGMP, GDP requirements and/or the Medical Device Directives.
• Ensure that the documentation processes are managed effectively and efficiently, which ensures traceability, integrity and accessibility; include filing, scanning, archiving per established requirements.
• Maintain Design History Files, validation reports, test reports, etc as defined by applicable regulations and standards.
• Manage the review of Device History Records (DHR) to support lot release.
• Administer the internal QMS training program and maintenance of training records.
• Administrator for Agile PLM basic configuration.
• Train relevant personnel on Agile, LMS, documentation standards and practices when required.
• Assist in external and internal audits when required.
• Able to work independently to perform multiple tasks in the assigned area.

• At least 5 years experience in QMS and Documentation Control.
• Able to deal with English and Mandarin counterparts.
• Excellent interpersonal and communication skill and possess positive attributes.
• High level of integrity.
• Able to work under stress and deliver work schedules (for both direct and indirect reporting lines).
• Good communication and interpersonal skills to build cross function and support.