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QC Engineer (Healthcare / Immediate / GMP / ISO) - PEOPLE PROFILERS PTE. LTD.

PEOPLE PROFILERS PTE. LTD.D01 Cecil, Marina, People’s Park, Raffles Place, SG

7 days ago

Job description

Roles & Responsibilities

1 year contract
Attractive Benefits
MNC

Responsibilities

Responsible for medical product release to the market.

Support the maintenance of Quality Management System, and to lead or assist in quality-related investigations to ensure compliance, continuous improvement, and operational excellence.

Act as the contact point for local medical gases and medical devices safety issues within normal business hours

Implementing local regulatory and global vigilance requirements.

Report medical gases adverse event and medical device incidents to Global team and local authority, if appropriate

Identify qualified resources for management of medical inquiries.

Safety related medical inquiry

Post-authorization safety studies requested by a competent authority including the results of such studies.

Requests for Risk Management System (RMS) and Risk Management Plan (RMP) by national competent authority if RMS and RMP are required by the national competent authority.

Updates any new medical gases related from the activity of local authority website monitoring.

Handling of adverse events and special situation cases

Follow-up on Individual Case Safety Report

Ensure personal data is managed according to local data protection legislation.

Process domestic and foreign cases according to local regulatory requirements, including adverse events, special situations, and medical events.

Maintain global training history and attend annual refresher training

Identify training needs and deliver training to new hired

Notify management mailbox and Global management any new, amended, renewals and withdrawal of marketing authorizations etc

Communicate any new product registration information update to the team

Respond to authority requests for information with support from Global management.

Prepare list of medical gases and medical devices sold locally.

Ensure requirement in Management of Safety Data Exchange Agreements is implemented.

Review of third-party contractors agreements to identify the scope of services provided by the third party and conduct risk ranking

Review and assure the correct handling of vigilance cases as per local contractual agreements (licensors, contract research organizations, etc.).

Reconciliate with third-party contractor on the number cases reported management every year.

Assess and track local Market Research, Patient Support Programs and Clinical studies.

Verify literature search information from any third party contracted literature search activity.

Monitor authority websites on at least a quarterly basis and document review , external regulatory, quality and safety environment.

Monitor local web site interface for reporting adverse events.

Perform quality incident trend analysis and identify any significant trend.

Discuss the quality incident trend during management review.

Perform reconciliation of medical information request according to company standards

Establish public website interface for local adverse event reporting.

Periodic Safety Update Reports and Risk Management Plan

Drive CAPA to closure for internal vigilance audit.

Audit planning and audit execution.

Audit finding follow-up : identify CAPA, approve CAPA, follow CAPA to closure, verify implementation of CAPA, audit closure.

Requirements

Min Diplomas / degree in a technical discipline (engineering preferred)

Post-graduate development programs, e.g., quality systems, change management, problem solving tools, project management.

Healthcare manufacturing processes and knowledge preferred.

Excellent interpersonal and presentation skills in order to communicate effectively with customers and senior management.

Able to demonstrate success in implementing change within a manufacturing environment through the application of recognised quality improvement tools such as FMEA, DOE, Six Sigma and Kaizen

Skilled with 8D reporting, robust CAPA determination and cause and effect diagram

Skilled in the application of defined quality management system disciplines (e.g. ISO) within a production manufacturing environment

Scientific method of data collection and analysis good understanding of or willingness to learn statistical process control (SPC)

Six Sigma black or green belt preferred

All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.

Interested applicants may wish to email your resume in a detailed Word format to cindy.char@peopleprofilers.com

We regret that only shortlisted candidates will be notified.

Cindy Char Sin Yi

cindy.char@peopleprofilers.com

EA License Number : 02C4944

Registration Number : R1765345

People Profilers Pte Ltd

Tel : 69509736

20 Cecil St, #08-09, PLUS Building, Singapore 049705

Tell employers what skills you have

Cecil

CAPA

Operational Excellence

FMEA

Quality Management

Legislation

Quality Improvement

Manufacturing Processes

Trend Analysis

Data Collection and Analysis

Medical Devices

Vigilance

Kaizen

Process Control

Six Sigma

Document Review

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Qc Engineer • D01 Cecil, Marina, People’s Park, Raffles Place, SG

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