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