Assistant Vice President Quality Assurance & Regulatory Affairs

Talent Search Recruitment - Indonesia; Sumatera Utara; Sur place; IDR 120 000 000 - 180 000 000; Plein temps

Résumé du poste

Talent Search Recruitment - Indonesia is seeking an Assistant Vice President of Quality Assurance & Regulatory Affairs to lead QA and regulatory compliance at the Sumatera Island facility in Indonesia. The role requires overseeing QMS, ensuring product quality, and driving CAPA programs across production.

Ideal candidates hold a Bachelor or Master in Polymer Science, Chemistry, or Chemical Engineering with at least 20 years in QA in chemical or medical device industries and solid knowledge of

Qualifications

• Bachelor/Master level degree in a relevant field.
• 20+ years of QA experience in chemical or medical devices industries.
• Knowledge of applicable Quality Standards.

Responsabilités

• Determine QMS requirements from incoming inspection to final product release.
• Review manufacturing processes and establish SOPs and work instructions for QMS.
• Validate and verify processes/products as required.
• Assure product quality at every production stage to minimize rejection and rework.
• Investigate defects, root causes, and implement CAPA.
• Train staff on product quality standards and safety requirements.
• Ensure social compliance standards and proper systems.
• Conduct internal audits for QMS and SMS to identify gaps and strengthen the system.
• Handle customer complaints and product failures with root cause analysis.

Connaissances

Quality Assurance

Regulatory Affairs

Leadership

GMP Standards

Process Improvement

Formation

Polymer Science

Chemistry

Chemical Engineering

Description du poste

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.