QA Specialist, Commercial Quality Indonesia Surgery

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.

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.

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations:

Jakarta Selatan, Jakarta Raya, Indonesia

Job Description

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 Commercial Quality Manager, Sub Cluster Singapore, Indonesia & Philippines Surgery.

Key Responsibilities

Site quality management system activities:

• 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

• 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.

• 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.

• Document control
  
  

Support and ensure site compliance to document lifecycle management.

• 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.

• 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.

• 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

• 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.

Education

Required Qualification and Core Competencies for the role:

At least BSc. in 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 Bahasa Indonesia together with computer literacy

Required Skills

Preferred Skills:

Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment