Assistant Vice President Quality Assurance & Regulatory Affairs

Talent Search Recruitment; Jakarta Utara; On-site; IDR 1.995.676.000 - 2.494.596.000; Full time

Job summary

A leading health-care group is seeking an Assistant Vice President of Quality Assurance & Regulatory Affairs in Indonesia. The role involves overseeing QMS operations in alignment with strategic business objectives, ensuring product quality at all production stages, and complying with relevant standards. The ideal candidate has at least 20 years of experience in quality assurance within the chemical or medical devices industries, a relevant degree, and must be between 40 to 45 years of age. Competitive package and growth opportunities offered.

Qualifications

• Minimum 20 years of relevant experience in quality assurance in chemical or medical devices industries.
• Knowledge of validation and qualification of processes/products required.
• Ideal age between 40 years to 45 years.

Responsibilities

• Determine QMS requirements from inspection to final product release.
• Review manufacturing processes to establish SOPs for QMS.
• Assure product quality at every stage of production.

Skills

Quality Management System (QMS)

Root cause analysis

Social compliance standards

Education

Bachelor/Master in Polymer Science, Chemistry or Chemical Engineering

Job description

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 dynamic sector.
• 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 the Company’s Strategic Business Objectives.
• The job will entail spending Monday to 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 final release 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 QMS system.
• Knowledge of validation and qualification of processes/ products is required.
• Assuring product quality requirements at every stage of the production and ensuring minimum rejection and 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 safety requirements.
• 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 implementation of CAPA.
• Acts as a role model in driving the assimilation of MST Core Values and Business Code of Conduct.

Ideal Candidate

• Bachelor/Master in Polymer Science, Chemistry or Chemical Engineering.
• Minimum 20 years of relevant experience in quality assurance in chemical or medical devices industries.
• Has relevant knowledge of the relevant Quality Standards applicable to Industry.
• Ideal age between 40 years to 45 years.