Sterility & Contamination Control Lead

No deviation Pte Ltd; Singapore; On-site; SGD 85,000 - 120,000; Full time

Benefits offered by this job

Generous Leave Policy

Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Shape the Future

Job summary

No deviation Pte Ltd is seeking a highly qualified specialist to support the site's contamination control and sterility assurance programme in a GMP environment. You will monitor microbiological and environmental data, lead investigations, CAPAs, and risk assessments, ensuring product quality and inspection readiness.

Collaborating with cross-functional teams, you will drive improvements, support validation activities, and maintain compliance with global SOPs and regulatory standards, reflecting

Qualifications

• Experience in sterility assurance and microbiological or contamination control within pharmaceutical/biotechnology environments.
• Ability to review documentation, processes and products to ensure GMP compliance.
• In-depth knowledge of regulatory requirements and GMP standards for sterility and microbiological control.
• Strong communication skills across shop floor to management to present complex topics.
• Ability to organize and lead routine investigations with a multi-disciplinary team.

Responsibilities

• Lead as SME for contamination control topics within your area of expertise.
• Conduct risk assessments related to contamination control.
• Oversee site activities and performance for contamination control systems.
• Lead investigations following contamination control failures and propose CAPAs.
• Collaborate with cross-functional teams to ensure product quality.
• Ensure presence on the shop floor to oversee practices and SOP compliance.
• Review contamination control data to propose improvements from monitoring and trends.
• Support validation protocols and related projects in your area of expertise.
• Perform microbiological trend analysis for EM, utilities, and personnel monitoring.
• Analyze microbiological data to identify trends and contamination risks.
• Prepare and present contamination control trend reports with actionable insights.
• Lead or support microbiological investigations, including RCA and effectiveness checks.

Skills

Sterility assurance

Microbiological control

CAPA investigations

GMP knowledge

Cross-functional communication

Job description

No deviation Pte Ltd is seeking a highly qualified specialist to support the site's contamination control and sterility assurance programme in a GMP environment. You will monitor microbiological and environmental data, lead investigations, CAPAs, and risk assessments, ensuring product quality and inspection readiness.

Collaborating with cross-functional teams, you will drive improvements, support validation activities, and maintain compliance with global SOPs and regulatory standards, reflecting