The posting
- 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 [email protected]
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: 69509736
20 Cecil St, #08-09, PLUS Building, Singapore 049705
