QA SITE HEAD

WuXi AppTec; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

WuXi AppTec is seeking a Senior Quality Manager to oversee site quality matters, ensuring product quality and meeting client expectations. The role covers establishing, optimizing and maintaining the quality system with GMP compliance.

The position requires reviewing procedures, leading CAPAs, hosting client audits and driving continuous improvement. Strong leadership and communication skills, with 5+ years in pharmaceutical quality management, are essential.

Qualifications

• Pharmacy or chemistry major with university degree or above.
• Familiar with GMP regulations and pharmaceutical production.
• Over 5 years of quality management experience in a pharmaceutical factory.
• Strong coordination and communication; ability to analyze problems scientifically; plan and monitor projects; lead subordinates.

Responsibilities

• Be responsible for site quality matters, ensure the product quality and meet client’s quality expectation.
• Review and approve quality procedures, quality manuals, annual/month quality review.
• Establish, optimize and maintain the company quality system, ensure regulator compliance and operability.
• Define effective CAPAs, ensure continuous improvement through deviation investigation, quality incident handling, quality review, self-inspections and external inspections.
• Ensure good communication with clients, maintain company quality imagination.
• Follow client quality agreement, meet client’s quality expectation.
• Host client auditing, respond to the audit report and follow up actions.
• Review and approve VMP and validation documents.
• Organize quality training, promote employee quality awareness and company quality culture.
• Notify top management and responsible management team in a timely manner regarding quality issues, quality trending etc.
• Comply with national and local EHS laws and regulations, and strictly implement all EHS policies, SOPs and rules of the Company.
• Participates in EHS working conference, EHS training, fire drill and other activities, continually learning EHS knowledge and improving skills, enhancing safety awareness, and actively participating in the establishment of EHS culture.
• Build a highly efficient team.
• Enable each team member’s initiative, enthusiasm and creativity.
• Energize the whole team.

Skills

Quality management

Coordination and communication

Leadership

Education

Pharmacy or chemistry degree

Job description

• Be responsible for site quality matters, ensure the product quality, and meet client’s quality expectation. Be responsible for establishing, optimization and maintenance of the quality system, ensure that the site quality activities comply with quality management requirement, such as;
• Review and approve quality procedures, quality manuals, annual/month quality review.
• Establish, optimize and maintain the company quality system, ensure the regulator compliance and operability.
• Define effective CAPAs, ensure the continuous improvement of the quality system by deviation investigation, quality incident handling, quality review, self-inspections and external inspections.
• Ensure good communication with clients, maintain company quality imagination.
• Follow client quality agreement, meet client’s quality expectation.
• Host client auditing, respond the audit report and follow up the actions.
• Review and approve VMP and validation documents.
• Organize quality training, promote employee quality awareness and company quality culture.
• Notify top management and responsible management team in a timely manner regarding quality issues, quality trending etc.
• Comply with national and local EHS laws and regulations, and strictly implement all EHS policies, SOPs and rules of the Company.
• Participates in EHS working conference, EHS training, fire drill and other activities, continually learning EHS knowledge and improving skills, enhancing safety awareness, and actively participating in the establishment of EHS culture.
• Build a highly efficient team.
• Enable each team member’s initiative, enthusiasm and creativity.
• Energize the whole team.

Job Requirements

• Education: Pharmacy or chemistry related major, university degree or above.
• Major: Understand pharmaceutical production, testing and quality management, be familiar with GMP related regulations.
• Work Experience: More than 5 years of quality management related experience in pharmaceutical factory.
• Work Capability: Have good coordination and communication skills; determine problems through scientific reasoning, collect information, understand facts, and draw correct and effective conclusions; preliminarily formulate research plans and specific implementation plans for each project, and track project progress.
• Leadership: Guide and supervise subordinates; responsible for work assignment, assessment, and motivation of subordinate staff.