QC Microbiologist
no deviation
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. Position Overview 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 nonroutine 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, nonviable 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.
- 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 rootcause analysis, and assisting with CAPA implementation where relevant.
- 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.
- 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.
- 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.
- 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.
Vacancy posted 9 days ago
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