全职 CQ Lead, Malaysia 工作, 薪水, DePuy Synthes Selangor 公司招聘中 - Ricebowl

Job Description

DePuy Synthes is recruiting for a CQ Lead, Malaysia, located in Petaling Jaya, Malaysia.

This role is responsible for the site management and execution of Quality Systems establishment, implementation and maintenance for Malaysia, including overseeing of Suppliers and Distributors, in order to meet the applicable regulatory and customer requirements and DePuy Synthes (DS) policies and standards.

Essential Job Duties and Responsibilities

Site quality management system activities:

1. Acquisition and divestiture:

• Provides quality support for acquisition and divestiture activities, including change control.

2. Adverse event and/or Health Authority reporting (where applicable)

• Responsible to report adverse events/product quality issues are reported to the health authority in the site if required by local regulation, and ensures robust processes are in place for timely reporting and closure.

3. Audit Readiness, including Inspection management:

• Ensures compliance and audit-readiness of site to DS Quality Policy Standards and applicable local regulatory requirements (i.e. GDP and GDPMD).Lead as site SME for inspection management by coordinating activities related to pre- and post- audit including providing briefing and guidance to all cross functional team, managing audit arrangement and lead in audit response to auditor.

4. Change Control

• Lead for site’s change control management. Responsible to ensure process is followed and records are managed in a timely manner with proper impact assessment, monitoring are taken. Monitors related metrics and initiates actions for improvement

5. Complaints management

• Lead the end to end complaint management for the site. Responsible to prepare and sign customer resolution letters when requested by complainant. Monitors trends, related metrics and initiates actions for improvement.

6. Combination product

• Ensures local regulations and DS standards related to combination products are met.

7. Document control

• Support and ensure site compliance to document lifecycle management.

8. Labeling and Packaging

• Provides Quality support (such as updating quality agreements, issuing redressing instructions) in repack/relabel operation to ensure compliance to internal procedures and local regulations. Monitors related metrics and initiates actions for improvement.

9. NC CAPA Management

• Lead for site’s NC/CAPA management. Responsible to ensure process is followed and records are managed in a timely manner with proper investigation, root cause analysis and corrective and preventive action taken. Monitors related metrics and initiates actions for improvement.

10. New Product Introduction and Product Discontinuation

• To provide Quality support during new product launch and establish any new quality processes to support commercial launch if applicable.
• To work with stakeholders to manage activities related to product discontinuation to ensure compliance to internal and external requirements.

11. Escalation and Field actions

• Oversee the management of Escalations, Field Action, Mock Field Action and Stop shipment applicable to the site.

12. Product Release and Product Returns

• Supports activities related to product inspection and release, temperature excursions and trade returns according to product specifications and internal procedures.

13. Purchasing Control, including POLO

• Support activities related to purchasing controls. Ensures suppliers/POLO are appropriately qualified, monitored and in compliance to up-to-date Quality Agreements, where applicable.

14. QSMR and metrics reporting

• Coordinates key quality metrics reporting. This includes Non-conformance, CAPA, Complaints, Change Control, Audit Actions tracking and monitoring as per timelines.

15. Quality Manual

• Responsible to establish and maintain site’s Quality Manual.

16. Records retention

• Provide guidance to LOCs on record retention process in collaboration with records coordinator.

17. 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.

Distributor quality oversight

1. This role is responsible for the execution and compliance of Quality Management Systems elements applicable to the Distributor as required per DS standards and applicable local regulatory regulation, including: product release and returns, handling of storage, temperature controls, traceability, repack relabels, loaner set management, and NC/CAPAs.

2. This role is also responsible for purchasing control activities related to the

distributor such as qualification, audits, and monitoring of distributor quality KPIs.

Required Qualification and Core Competencies for the role:

Requires knowledge and understanding of industry and regulatory standards, and overall DS Quality Systems. Needs experience in training, supervising and risk-based approach in execution. With good interpersonal and communication skills who can interface and influence stakeholders. Demonstrated ability to plan and manage inspection activities related to assigned responsibilities. Skill in multiple computer based tools. Can deliver results.

1. Good interpersonal and communication skills, with a collaborative approach to stakeholders.

2. Analytical and problem-solving capabilities

3. Acumen for prioritization and decision making

4. Demonstrate change management and project management ability

5. Knowledge and application of quality and regulatory requirements.

Experience Range from 3-8 years.

• Required - Good Communication skill, basic understanding of QMS elements and Medical device regulation in Malaysia.