Commercial Quality Specialist
1 year contract
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.
This role is responsible for supporting the site management and execution of Quality Systems establishment, implementation and maintenance for business including overseeing local Distribution Centres to meet the applicable regulatory and customer requirements and organization policies and standards. In addition, this role shall assist other operational tasks as required or assigned.
Essential Job Duties and Responsibilities
Site quality management system activities:
1. CAPA Management
- Coordinate with internal/external stakeholders to ensure timely closures of CAPA records.
2. Change Control
- Ensures process is followed and records are managed in a timely manner with proper impact assessment, monitoring is taken.
- Monitors related metrics and initiates actions for improvement.
3. Document Control
- Support document lifecycle management activities to ensure site compliance.
- Perform related activities such as periodic document review and document revision.
4. Training Management
- Support and ensure site compliance to GxP training plan for quality system elements covered by the site's quality manual.
- This role is also responsible for the metrics, communications, reports and non-conformance related to these areas.
5. Product Release
- Supports activities and assessments related to product temperature excursions according to product specifications and internal procedures.
6. Audit Readiness, including Inspection Management:
- Support Commercial Quality (CQ) department and ensure compliance and audit-readiness of site to company's Quality Policy Standards and applicable local regulatory requirements
- Coordinates activities related to pre- and post- audit including managing audit arrangement and logistics.
7. Complaints Management
- Support complaint intake, outreach, field sample retrieval support, and preparing customer resolution letters when requested by complainant.
8. Purchasing Control
- Support monitoring activities related to supplier/distributor management as required (e.g. Distributor Quality KPIs and NC/CAPAs)
- Support the execution and compliance of Quality Management Systems elements applicable to the Distributor as required per organization standards and applicable local regulatory regulation, including: product release, handling of storage, temperature controls, traceability, and NC/CAPAs.
9. QSMR and Metrics Reporting
- Coordinates activities related to pre- and post- QSMR meetings including preparation of key quality metrics (such as Non-Conformance, CAPA, Complaints, Change Control, Audit Actions tracking and monitoring as per timelines), managing meeting logistics and documentation.
- Prepare monthly commentaries for metrics not meeting KPI, as required.
10. Records Retention
- Support record retention process in collaboration with records coordinator
Minimum Qualification
- Bachelor's degree in Science, Engineering and Technical subjects with minimum 1 year of industry experience.
- Excellent computer and digital proficiency e.g. Microsoft Applications, Microsoft Power Apps, etc.
- Excellent analytical skill to proactively identify resolution.
- Must be able to work independently with minimum supervision to meet tight deadlines
- Demonstrated ability to plan and coordinate activities related to assigned responsibilities. Skill in multiple digital tools.
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 [Confidential Information]
EA License: 94C3609
Reg No: R1440247
