QA Site Head (API Experience) | Pharma MNC | Greenfield Plant Start-Up

The GMP Group; Singapore; On-site; SGD 80,000 - 150,000; Full time

Job summary

GMP Technologies (S) Pte Ltd is seeking a Quality Manager to take overall responsibility for all quality matters at the plant, ensuring product quality meets customer expectations and regulatory requirements.

You will develop and maintain the QMS, drive CAPA through investigations and audits, lead staff, host customer audits, and ensure EHS policies are followed while strengthening the company's quality culture.

Qualifications

• Min. Degree or above in Pharmacy, Chemistry, or a related field.
• Knowledge of pharmaceutical manufacturing, testing, and quality management; GMP regulations.
• Over 5 years of experience in quality management within the pharmaceutical industry.
• Able to identify problems through scientific reasoning, gather information, understand the facts, and draw accurate conclusions.
• Able to develop preliminary research plans and detailed implementation plans for each project, and track progress.
• Guide and supervise subordinates, including work allocation, performance evaluation, and motivation.

Responsibilities

• Take overall responsibility for all quality matters at the plant and ensure customer quality expectations.
• Review and approve quality procedures, manuals, and annual/monthly reports.
• Establish, optimize, and maintain the quality management system, ensuring regulatory compliance.
• Develop CAPAs through deviation investigations, quality event management, quality reviews, self-inspections, and external audits to drive continuous improvement.
• 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.

Skills

Quality management

GMP regulations

Regulatory compliance

Auditing

Education

Pharmacy or Chemistry degree

Job description

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: R11092393