Qc Microbiologist

**Job Summary**:
The **QC Microbiologist** plays a crucial role in ensuring the sterility, cleanliness, and microbiological quality of **Intraocular Lenses (IOLs)** and other medical devices. This role involves conducting microbiological testing, environmental monitoring, and compliance verification per regulatory standards such as **ISO 13485, ISO 14971, USP, EU MDR, and FDA 21 CFR Part 820**.

**Key Responsibilities: Microbiological Testing & Product Sterility Assurance**:

- Conduct **bioburden testing, sterility testing, and endotoxin (LAL) testing** on IOLs and related medical devices.
- Perform microbial identification and validation studies to ensure product safety.
- Monitor sterilization processes (e.g., **autoclave, ethylene oxide (EtO), gamma radiation, dry heat**) and validate sterilization efficacy.
- Conduct container closure integrity testing (CCIT) to prevent microbial contamination.
- Ensure compliance with **ISO 11737-1 & 11737-2** for microbiological evaluation.

**Environmental & Cleanroom Monitoring**:

- Perform **environmental monitoring (airborne particulates, viable count, and surface monitoring)** in **cleanrooms (ISO Class 5, 7, & 8).**:

- Conduct **water and compressed air quality testing** for microbiological contamination.
- Validate and monitor the performance of **HEPA filters, air samplers, and microbial settling plates** in controlled areas.
- Implement **aseptic techniques** and **gowning procedures** to minimize contamination risks.

**Regulatory Compliance & Documentation**:

- Ensure strict adherence to **ISO 13485, EU MDR, FDA 21 CFR 820, and GMP** microbiological requirements for medical devices.
- Maintain detailed records of microbiological test results, investigations, and trends.
- Participate in regulatory audits (FDA, CE, ISO) by providing microbiological compliance data.
- Investigate and document **OOS (Out of Specification), OOT (Out of Trend), and CAPA (Corrective and Preventive Action)** for microbiological deviations.

**Equipment Handling & Laboratory Management**:

- Operate and calibrate **autoclaves, incubators, air samplers, biohazard hoods, and PCR machines.**:

- Validate and maintain sterility assurance levels (SAL) for IOL manufacturing processes.
- Ensure proper media preparation, growth promotion testing (GPT), and laboratory sterility control.

**Training & Process Improvement**:

- Train personnel on **cleanroom behavior, aseptic processing, and microbiological best practices.**:

- Collaborate with R&D and Quality Assurance (QA) teams to enhance sterility assurance programs.
- Stay updated with the latest **ISO, USP, and FDA microbiological guidelines** applicable to medical devices.

**Qualifications & Experience**:

- **Education**: B.Sc./M.Sc. in **Microbiology, Biotechnology, Biochemistry, or a related field.**:

- **Experience**: 2-3 years of experience in **microbiological quality control within a medical device (IOL) manufacturing environment.**:

- **Skills**:

- Strong knowledge of **sterility testing, bioburden analysis, and endotoxin testing.**:

- Familiarity with **ISO 13485, ISO 11737, USP
, USP
, and FDA 21 CFR 820.**:

- Hands-on experience with **cleanroom monitoring, aseptic processing, and sterilization validation.**:

- Proficiency in handling **microbial identification techniques (Gram staining, biochemical assays, PCR).**

**Preferred Certifications**:

- **ISO 13485: Medical Device Quality Management System Certification**:

- **GMP, GLP, and HACCP Certification**

**Work Environment**:

- Laboratory and cleanroom-based role with strict adherence to **safety and sterility protocols.**:

- May require working in **Class 100/ISO 5 controlled environments.**

**Job Types**: फ़ुल-टाइम, स्थायी

Pay: ₹11,609.41 - ₹30,000.00 per month

**Benefits**:

- पेमेंट वाली छुट्टियाँ
- बीमार होने पर ली गई छुट्टियों का पेमेंट

Work Location: In person