Quality Executive
1 year contract, potential to renew
Come and join us!
Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?
“FIND YOUR PLACE” by joining a world-class MNC Healthcare company
Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.
Company Description:
Our client is an MNC Healthcare company. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, they are empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.
Overall Purpose of the Job
- The Quality Executive will assist in the management of the day-to-day aspects relating to Quality Management Systems and Compliance
- 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.
Job Description
- Manage quality in product receiving process (including receiving inspection) with 3PL
- Support the inventory management in quarantine cage with 3PL
- 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.
- Supports repack, relabeling, over labeling, kitting and reworking operations conducted
- Back-up Coordinator for stop shipment/ recall processes within the DC.
- Support quality management of repacking, relabeling, over labeling, kitted, and reworked
- Support the QA release of product repackaged, relabeled, over labeled, kitted, and reworked
- Supports product complaints, service complaints process and systems.
- Acts as an administrator for automated IT platforms and audits and change control.
- Manages / supports records and document management.
- Supports training management.
- Supports Quality audits and related action planning/implementation.
- Support Escalation of quality issues to the management.
- Responsible for the capture and processing of complaints reported to DC (Products and Distribution related complaints)
- Support the Quality audits (Internal, External and Supplier) of DCs
- Support the GxP (GMP, GDP) compliance of the DC.
- Responsible for day-to-day activities of base business.
Authorities
- Preparation / Review and Approval of validation documents
- Review and approval of repack relabel batch release.
- Product hold and release disposition in SAP for non-conforming material
- Product defect review and approval
- Initiation and review of procedures
- Review and approval of material destructions.
- Approval of Material movement in Quality Hold
- Approver for material destruction declaration form, QA Rejection letter
Qualification:
- Degree in Science (Life Sciences, Microbiology, etc) / Engineering required with minimum 2 years’ experience in QC or QA Function
- Preferably with working experience in Medical Device / Pharmaceutical Industry.
Technical Skills:
- Demonstrated knowledge and experience in quality or operations function.
- Task oriented with proven experience in the delivery high quality work.
- Proficiency in Microsoft Office (PowerPoint) other tools required to develop training materials
- Good analyzing / decision making ability.
- Customer (internal and external) driven approach.
- Knowledge of Good Distribution Practices (GDP), GxP and validation
- Demonstrated knowledge and application of ISO9001, ISO13485 and other international standards preferable.
- Knowledge of manufacturing environment is a plus.
Interested parties, please apply through this link https://jnj-apac.talent-pool.com/projects OR click on APPLY button.
Alternatively, you can share your CV at [email protected]
EA License: 94C3609
Reg No: R1440247