QAQC Engineer

Job ID: 9394YX4Y

• 1 year contract
• Attractive Benefits
• MNC

Responsibilities

• 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 and required to be reachable 24 hours/day, 7 days/week.
• 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
• Post-authorization safety studies requested by a competent authority including the results of such studies.
• Any regulatory action/request involving vigilance within 24-hours from awareness, to ensure that a regulatory response can be prepared within the agreed timelines.
• 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

We regret that only shortlisted candidates will be notified.

Cindy Char Sin Yi

EA License Number: 02C4944

Registration Number: R1765345

People Profilers Pte Ltd

Tel:

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