Sr. Manager- Quality Assurance-Regulatory Affairs- Indonesia

Role

The incumbent will be

• Responsible for the Quality Assurance and Regulatory Affairs operations in collaboration with the Companys Strategic Business Objectives.

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 (Correction and Preventive Action)
• Acts as a role model in driving the assimilation of the Organization and Business Code of Conduct

Preferred candidate profile

• Bachelor/ Masters in Polymer Science, Chemistry or Chemical Engineering
• Minimum 10 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

Perks and benefits

The Company provides tax free salary in US Dollars, furnished accommodation, Conveyance and other benefits