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 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.

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