Assistant Vice President Quality Assurance & Regulatory Affairs

Talent Search Recruitment - Indonesia; Sumatera Utara; On-site; IDR 550.000.000 - 650.000.000; Full time

Job summary

A leading healthcare group in Indonesia is looking for an Assistant Vice President Quality Assurance & Regulatory Affairs. This role demands over 20 years of expertise in quality assurance and regulatory affairs in the chemical or medical devices industries. Responsibilities include overseeing the Quality Management System, ensuring compliance with industry standards, and leading audits. The ideal candidate holds a relevant degree and has strong knowledge of quality standards. This position requires a dedicated approach to product quality and compliance in a fast-paced environment.

Qualifications

• At least 20 years of relevant experience in quality assurance in chemical or medical devices industries.
• Knowledge of validation and qualification of processes/products.

Responsibilities

• Determine the QMS requirements from incoming inspection to final product release.
• Review manufacturing processes to establish required SOP and WI.
• Conduct internal audits for QMS and SMS to identify gaps.

Skills

Quality Assurance

Regulatory Affairs

Root Cause Analysis

SOP Development

Education

Bachelor/ Masters in Polymer Science, Chemistry or Chemical Engineering

Job description

Assistant Vice President Quality Assurance & Regulatory Affairs

Job Openings Assistant Vice President Quality Assurance & Regulatory Affairs

About the job Assistant Vice President Quality Assurance & Regulatory Affairs

Assistant Vice President, Quality Assurance & Regulatory Affairs
(Location: Sumatera Island, Indonesia)

Company Highlights

• Candidate will join a leading health-care group that is an industry-leader in a fast-growing and dynamicsector.
• The Company is a wholly-owned subsidiary of a global multinational, with over USD Billions in sales.

Position Highlights

• Responsible for the Quality Assurance and Regulatory Affairs operations in collaboration with theCompany's Strategic Business Objectives.
• The job will entail spending Monday Saturday (half day) at the Company's production facility in Sumatera Island,Indonesia.

Job Responsibilities

• Determines the QMS requirements of the Company starting from the incoming. inspection to the finalrelease of the products as per the required standard and customer requirements.
• Reviews the manufacturing processes and establishes the required SOP and WI to strengthen the QMSsystem.
• Knowledge of validation and qualification of processes/ products is required.
• Assuring product quality requirements at every stage of the production and ensuring minimum rejectionand rework in the process.
• Work to find defects, understand the causes, and provide solutions to defects and future problems.
• Ensures that other employees are trained to understand product quality standards and safetyrequirements.
• Have a clear knowledge of social compliance standards and establish systems and procedures.
• Periodically conduct an internal audit for QMS and SMS to identify the gaps to strengthen the system.
• Handling customer complaints and product failures by root cause analysis and effective implementationof CAPA.
• Acts as a role model in driving the assimilation of MST Core Values and Business Code of Conduct.

Ideal Candidate

• Bachelor/ Masters in Polymer Science, Chemistry or Chemical Engineering.
• Minimum 20 years of relevant experience in quality assurance in chemical or medical devises industries.
• Has the relevant knowledge of the relevant Quality Standards applicable to Industry.