QA Specialist, Commercial Quality Thailand

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description

Overall purpose of job:

Johnson & Johnson (J&J) MedTech is a provider of medical devices and diagnostics products to the market. It ensures that its products and services are scientifically sound and of high quality to help heal cure disease and improve the quality of life of patients and consumers. The Johnson & Johnson Commercial Quality department provides quality oversight and support to the local operating companies in the areas of strategy and planning quality system oversight compliance reporting portfolio and product lifecycle management product supply and distribution.

Responsible for E2E support on appointed Medtech process e.g. repack/relabel NC/CAPA Change Control Warehouse (DC/3PL/Distributor plus) complaint handling and support commercial quality team in execution of Quality Systems implementation and maintenance for Thailand and LCM countries (Laos Cambodia and Myanmar) including overseeing of 3PLs and Distribution Centres in order to meet the applicable regulatory and customer requirements and Johnson & Johnson policies and standards

This role reports solid line to Senior Commercial Quality Manager SEA & India Cluster EP.

Key responsibilities:

Site quality management system activities:

1. Adverse event and/or Health Authority reporting

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

2. Change Control

Lead site 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.

3. 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.

4. Document control

Support and ensure site compliance to document lifecycle management.

5. 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.

6. NC CAPA Management

Lead for 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.

7. Training Management

Support and ensure compliance to GxP training plan for quality system elements covered by the quality manual.

This role is also responsible for the metrics communications reports and non-conformance related to these areas

8. Others assigned work from line manager to support the business and help to develop leadership skills 3PL and Distributor quality oversight

This role is responsible for the execution and compliance of Quality Management Systems elements applicable to the 3PL and Distributor as required per J&J standards and applicable local regulatory regulation including: handling of storage temperature controls traceability repack relabels loaner set management and NC/CAPAs.

Required Qualification and Core Competencies for the role:

Education:

At least Science or Engineer or Pharmacy or equivalent from a reputable university preferably with excellence academic background

Professional Experience:

At least 1 year professional experience or leading in the field of Quality Assurance Business Quality or related functions

Experience of quality audit

Excellent interpersonal leadership and quality management skill exposure to quality standard e.g. ISO GMP GDP RA requirements will be desirable

Experience of exposure to Regional communication

Capability to communicate and good coordination and interpersonal skills

Good command of written and spoken English and Thai language together with computer literacy

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Preferred Skills: