No deviation

QC Microbiologist

No deviation  •  Singapore, SG (Onsite)  •  6 days ago
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Job Description

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

The QC Microbiologist is responsible for performing environmental monitoring (EM) and microbiological testing to ensure that manufacturing facilities, utilities, and critical cleanroom environments comply with regulatory and internal quality standards. This role conducts routine and non‑routine EM sampling, microbial analysis, and data evaluation in accordance with approved SOPs, test methods, and current Good Manufacturing Practices (cGMP).
The Microbiologist ensures accurate and timely documentation of EM results, participates in investigations for environmental excursions, supports laboratory and cleanroom operations through 5S and equipment maintenance, and contributes to maintaining a state of control across the facility. As a key member of the Quality Control Microbiology team, this role supports product quality, regulatory compliance, and overall business and production needs.

Key Responsibilities

Environmental Monitoring & Microbial Testing

  • Perform routine and non-routine EM sampling (e.g., viable air, non‑viable particle counts, surface contact plates, settling plates, personnel monitoring) in accordance with SOPs and cGMP.
  • Conduct microbiological analyses such as bioburden, endotoxin, microbial identification, and growth promotion tests where required.
  • Ensure timely and accurate recording of EM data in compliance with GDP and cGMP.

Compliance & Documentation

  • Document all sampling activities, test results, and observations accurately in approved forms and systems.
  • Review data for completeness and escalate any abnormalities or excursions (OOS/OOT/EM alerts) to the supervisor.
  • Support deviation investigations by providing data, participating in root‑cause analysis, and assisting with CAPA implementation where relevant.

Laboratory & Cleanroom Support

  • Perform basic troubleshooting of microbiology laboratory equipment (incubators, particle counters, bio-safety cabinets, autoclaves).
  • Support EM equipment and consumable inventory management, ensuring availability for routine operations.
  • Maintain lab and sampling areas in accordance with 5S and safety requirements.

Cross-functional Support

  • Collaborate with Manufacturing, QA, and Facilities teams during EM-related investigations or cleanroom recovery activities.
  • Assist in training new analysts on EM techniques, sample handling, and laboratory procedures.
  • Perform any other duties as assigned by the Supervisor/Manager.

Required Qualifications

  • Diploma or Degree in Microbiology, Life Sciences, Biotechnology, or a related scientific discipline.
  • 1–3 years of experience in Quality Control Microbiology or Environmental Monitoring in a GMP-regulated environment (pharmaceutical, biologics, or medical device preferred).
  • Hands-on experience with cleanroom gowning and EM sampling techniques is an advantage.
  • Demonstrated ability to learn procedures quickly and work independently in classified cleanroom areas.
  • Strong attention to detail and commitment to maintaining high-quality standards while meeting operational timelines.
  • Required to work 12 hours day shift.


Why join us?

  • Generous Leave Policy.
  • Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
  • Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
  • Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
  • Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

No deviation

About No deviation

Founded in 2007, No deviation is a trusted partner to pharmaceutical and biotech companies seeking smarter ways to deliver compliance. From engineering consultancy to CQV execution, regulatory compliance, and digital enablement, we support our clients across the entire project lifecycle in Asia, Europe.

We specialise in:

CQV (Commissioning, Qualification & Validation)

Lean, risk-based approaches aligned with GAMP 5, Annex 15, and ASTM E2500.

Quality, Compliance & Regulatory

Audit readiness, QMS remediation, documentation, and training.

Project Management & Technical Support

From operational readiness to vendor coordination.

Digital Enablement

Implementation of paperless validation (e.g. Kneat Gx), data integrity, and process digitalisation.

Specialised Training & Talent Support

Upskilling programs and resource placement to accelerate project success.

Our approach is rooted in patient safety, process understanding, regulatory compliance, and a constant drive for operational excellence in terms of safety, quality, delivery, and cost.

If you’re troubleshooting a deviation, planning a major CQV deployment, or scaling digital validation tools, we work side-by-side with your teams to deliver meaningful outcomes. Our methodology draws from ICHQ9 risk principles, with a hands-on framework: Understand - Observe - Define - Implement.

Want to learn more about paperless CQV, digital QMS, or project-ready resources? We’re happy to talk. Visit nodeviation.com to explore how we can support you.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Singapore, SG
Year Founded
2007
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