About the role

This is a quality assurance role focused on developing and implementing quality assurance policies and procedures in accordance with regulatory standards, including PIC/s and ISO 9001 requirements. You will establish and maintain a comprehensive quality management system (QMS) to ensure compliance with all applicable regulations and guidelines.

Key responsibilities

Develop and implement quality assurance policies and procedures in accordance with regulatory standards, including PIC/s and ISO 9001 requirements

• Establish and maintain a comprehensive quality management system (QMS) to ensure compliance with all applicable regulations and guidelines

• Conduct thorough investigations into deviations and non-conformities, identifying root causes and implementing corrective and preventive actions (CAPA) to address underlying issues

• Collaborate closely with cross-functional teams to implement preventive measures and improve processes to minimize the occurrence of deviations and non-conformities

• Oversee validation activities for manufacturing processes, equipment, facilities, and computer systems, ensuring compliance with regulatory requirements and industry best practices

• Ensure the company is capable of undergoing audits by both customers and regulatory authorities, both domestically and internationally

• Manage document control processes, including the development, review, approval, distribution, and maintenance of quality-related documents and records

• Provide comprehensive training and ongoing guidance to personnel involved in manufacturing processes, ensuring their full awareness and understanding of quality assurance principles and practices

• Monitor key performance indicators (KPIs) to track and measure quality performance, implementing strategies to enhance product quality and safety

• Serve as a subject matter expert on quality assurance matters, providing guidance and support to internal stakeholders as needed

About you

• Bachelor's degree in pharmaceutical science

• Minimum of 8 years of progressive experience in quality assurance roles within the pharmaceutical or related industry, with a solid understanding of regulatory standards and requirements, including PIC/s and ISO 9001

• In-depth knowledge of regulatory requirements governing pharmaceutical manufacturing and quality assurance, including FDA, EMA, PMDA, PIC/s, and ISO 9001 guidelines

• Excellent problem-solving skills with a proactive approach to identifying and resolving quality-related issues, as well as implementing preventive measures to mitigate risks

• Experience in validation activities, including process validation, equipment qualification, and computer system validation

• Proficiency in document control processes and systems, with experience managing quality-related documents and records

• Strong leadership and managerial skills, with the ability to effectively lead and develop a high-performing team

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders at all levels

• Demonstrated ability to drive process improvements and implement best practices to enhance quality and compliance

Benefits

• Comprehensive Medical Coverage

• Annual Health Check-ups

• Provident Fund

• Uniform Allowance

• Company Shuttle Service

• Annual Bonus

• Annual Salary Increment

• Performance-Based Incentives: Monthly increments

• Overtime Pay

• Shift Allowance

• Prescription Reimbursement

• Employee Purchase Program

• Group Purchase Program

• Annual Company Trip

• Sports and Recreational Activities

• New Year Party

• Death Benefits

• Family Assistance: Financial support for births, marriages, or deaths of immediate family

• Special Leaves

• Ordination Leave

• Annual Leave

• Birthday Celebrations