QA Site Head (API experience)| Pharma MNC | New Plant Start-Up

gmp technologies (s) pte ltd; Singapore; Sur place; SGD 90 000 - 130 000; Plein temps

Résumé du poste

GMP Technologies (S) Pte Ltd (EA Licence: 11C3793) seeks a Quality Leader to oversee all quality activities at the Singapore plant. You will drive the quality management system, ensure GMP compliance, and lead CAPA programs to continually improve product quality and customer satisfaction.

Responsibilities include reviewing quality procedures, coordinating audits, supervising a team, and engaging with customers to meet quality expectations.

Qualifications

• Bachelor's degree or above in Pharmacy, Chemistry, or related field.
• Knowledge of pharmaceutical manufacturing, testing, and quality management with GMP understanding.
• 5+ years of quality management experience in pharmaceuticals.

Responsabilités

• Take overall responsibility for all quality matters at the plant and ensure product quality meets customer expectations.
• Establish, optimize, and maintain the quality management system for regulatory compliance and practical implementation.
• Develop CAPAs through deviation investigations, audits, and quality reviews to drive continuous improvement.
• Maintain communication with customers and uphold the company's quality image.
• Implement customer quality agreements and ensure customer quality expectations are met.
• Host customer audits, respond to audit reports, and drive corrective actions.
• Review and approve the Validation Master Plan and related documents.
• Organize quality training to strengthen quality culture and awareness.
• Report quality issues and trends to management and responsible personnel.
• Ensure compliance with EHS laws and internal EHS policies; participate in EHS activities.

Connaissances

Quality management

GMP regulations

Problem solving

Project planning

Team leadership

Customer communication

Formation

Bachelor's degree in Pharmacy or Chemistry

Description du poste

Responsibilities

• Take overall responsibility for all quality matters at the plant, ensuring product quality meets customer expectations. Responsible for establishing, optimizing, and maintaining the quality management system to ensure all plant quality activities comply with quality management requirements, including:


• Review and approve quality procedures, quality manuals, and annual/monthly reports.


• Establish, optimize, and maintain the company's quality management system, ensuring regulatory compliance and practical implementation.


• Develop effective CAPAs through deviation investigations, quality event management, quality reviews, self-inspections, and external audits to drive continuous improvement of the quality management system.


• Maintain good communication with customers and uphold the company's quality image.


• Implement customer quality agreements and ensure customer quality expectations are met.


• Host customer audits, prepare responses to audit reports, and follow up on corrective actions.


• Review and approve the Validation Master Plan (VMP) and related validation documents.


• Organize quality training to enhance employees' quality awareness and strengthen the company's quality culture.


• Promptly report quality issues, quality trends, and other relevant matters to company management and responsible personnel.


• Comply with national and local government EHS laws and regulations, and strictly implement the company's EHS policies, SOPs, and regulations.


• Participate in EHS meetings, EHS training, fire drills, and other activities; continuously develop EHS knowledge and skills, strengthen safety awareness, and actively contribute to building an EHS culture.

Requirements

• Min. Degree or above in Pharmacy, Chemistry, or a related field.


• Knowledge of pharmaceutical manufacturing, testing, and quality management, with a good understanding of relevant GMP regulations.


• More than 5 years of relevant experience in quality management within the pharmaceutical industry.


• Able to identify problems through scientific reasoning, gather information, understand the facts, and draw accurate and effective conclusions.


• Able to develop preliminary research plans and detailed implementation plans for each project, and track project progress.


• Guide and supervise subordinates in their work. Responsible for work allocation, performance evaluation, and motivation of subordinate employees.

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh| Registration No: R1109239