Job Description Requisition ID: 1905758372W
The Quality Executive will assist in the management of the day to day aspects relating to Quality Management Systems and Compliance at MD&D Regional Distribution Center ASIAPAC (Singapore Logistic Hub - SLH).
The Quality Executive owns and implements quality assurance programs designed to ensure effective and consistent processes with established standards.
The Quality Executive works closely with SLH Operations and 3PL to drive timely resolution on Quality related issues.
Duties and Responsibilities: Distribution and Inventory Management Processes
- Manage quality in product receiving process (including receiving inspection) with 3PL within the DC.
- Support the inventory management in quarantine cage with 3PL in DC.
- Quality oversight on 3PL product destruction process.
- Lead resolution in non-conformances and discrepancies in a timely manner.
- Coordinate between 3PL, Source co. or Franchise on the monitoring of ambient environment (temperature and humidity as required) and handling of issues according to predefined agreements.
- Support repack, relabeling, over labeling, kitting and reworking operations conducted within the DC.
- Back-up Coordinator for stop shipment/ recall processes within the DC.
Special Processes (Repack-Relabel)
- Support quality management of repacking, relabeling, over labeling, kitted, and reworked within the DC.
- Support the QA release of product repackaged, relabeled, over labeled, kitted, and reworked within the DC.
Quality Management Systems
- Support CAPA, NCR, product complaints, service complaints process and systems.
- Act as a administrator for automated IT platforms for NC/CAPA and audits and change control
- Manage / support records and document management.
- Support training management.Supports Quality audits and related action planning/implementation.
- Perform gap assessment and roll-out of quality programs.
- Support Escalation of quality issues to the management.
- Responsible for the capture and processing of complaints reported to DC (Products and Distribution related complaints)
Compliance
- Support the Quality audits (Internal, External and Supplier) of DCs
- Support the GxP (GMP, GDP) compliance of the DC
Site specific Responsibilities
- Responsible for day to day activities of base business.
Qualifications - Degree in Science (Life Sciences, Microbiology, etc) / Engineering required.
- Preferably with working experience in Medical Device / Pharmaceutical Industry
- Demonstrated knowledge and experience in quality or operations function.
- Task oriented with proven experience in the delivery high quality work
- Fluency in English language required.
- Good communication skills
- Good work ethic, integrity and respect
- Proficiency in Microsoft Office (PowerPoint) another tools required to develop training materials
- Good analyzing / decision making ability
- Customer (internal and external) centric approach
- Knowledge of Good Distribution Practices (GDP), GxP and validation
- Demonstrated knowledge and application of QSR, ISO9001, ISO13485 and other international standards.
- Knowledge of manufacturing environment is a plus.
- At least 2 years experience in QC or QA Function of any Medical devices or Pharmaceuticals Industry.
Please note: there is a preferred candidate for this position who has been performing in the position under a contract arrangement. The purpose of advertising this role is aligned to our Global posting policy and in the spirit of transparency to identify other potential employees / candidates who may be interested in being considered for this position.
Primary Location
Singapore-Singapore-Singapore-
Organization
Johnson & Johnson Pte. Ltd. (8435)
Job Function Quality (Generalist)
Requisition ID
1905758372W
