Job Description

Who We Are
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare sector. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

Job Purpose: You will support the QMS/ GMP/ GDP training program and/ or FDA and other agency regulations and industry practices awareness program, coordinating and ensure closure of Customer Complaint, CAPA, Change Control, Management Review, lead the Internal Audits and maintain Document Control system.

Job Responsibilities:

• Supports the maintenance of QMS for conformance to requirements and Company policies and documents these systems in the QA Policies / Procedures Manual.

• Coordinate with Technical Support at Business Unit any SAP System issue that impact the daily operations and assist in the promptly resolution.

• Assures receival, distribution to QC Labs of returned goods for customer complaint testing.

• Monitoring of complaints Queries and develop monthly reports to the Quality Manager / Quality Engineer(s).

• Assist in the coordination of meeting with other relevant Process Owners to discuss Customer Complaints / CAPA.

• Administrates the Change Control system and ensure it is updated.

• Develop and publish monthly reports of open Change Control.

• Monitoring and track the Quality Notification / Deviation to ensure update and closure by actions owner(s).

• Develop and publish monthly reports of open Quality Notification / Deviations.

• Administrates the Document Control system and ensure it is updated.

• Coordinates the QMS / GMP / GDP training program and/ or awareness of FDA and other agency regulations and industry practices for new hired employees and annual refresher.

• Coordinates internal audits and external audits.

• Assists in the preparation of presentations for Management Review and Metrics Maintenance/ Reporting.

• Maintains Quality Master Data in SAP System.

• Maintains an accurate electronic and hardcopy Master Record filling system.

• Maintains Documentation Control System on Network to comply with internal requirements and with regulations on security, retention, accessibility, etc.

• In conjunction with Quality Engineer - Systems provides technical assistance on software associated with the SAP, SAP-EcoMS, Trackwise and/or PEGA.

• Participates and contributes to continuous improvement activities. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements, brings regulatory compliance questions/ issues to the attention of management.
  

Our Requirements:

• Minimum 3 to 5 years’ experience in an industrial QA environment (such as Validation, QMS, Doc Control, Complaint handling and Change Control handling) in medical devices, pharmaceutical or life science industry.

• It will be advantage with working knowledge of current QSR's, ISO, and ANVISA standards.

• Knowledge and experience in SAP, Excel, Word, and Quality Systems Software (e.g. Trackwise).

• Effective interpersonal and problem-solving skills.
  

Culture and Benefits Here at BD, we embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve strategic imperatives of the organization. Our leaders are committed, engaged and accountable to making talent our top priority.

How To Apply Submit your application by clicking on the “apply” button at the top of the page.

Primary Work Location SGP Tuas - Tuas Plant

Work Shift SG Normal Office 0745-1645 (Singapore)