QC Microbiologist Job Opening at Medicare Hygiene Limited – Apply on Biotecnika

MSc QC Microbiologist Jobs at Medicare Hygiene Limited – Apply on Biotecnika

Medicare Hygiene Limited

QC Microbiologist (Sterile Products)

Company: Medicare Hygiene Limited

Location: Sari, Ahmedabad, Gujarat, India

Job Type: Full-time, Permanent

Department: Quality Control (Microbiology)

Experience: 2 to 3 years

Pay: ₹25,000.00 – ₹35,000.00 per month

Job Summary

Medicare Hygiene Limited is a leading manufacturer and supplier of surgical dressing materials and wound care products, adhering to strict international quality standards. We are committed to patient safety through excellence in quality control and sterile manufacturing processes.

The Quality Control Microbiologist will be responsible for executing and managing all microbiological testing, validation, and monitoring activities to ensure that all sterile products, processes, and the manufacturing environment comply with internal procedures, ISO 13485, and other regulatory standards. This role is critical in maintaining the sterility and quality assurance of our medical devices.

Key Responsibilities

• Product Quality & Release: Perform Bio-burden testing, execute Stability studies, and provide final release of sterile finished goods. Preserve and monitor Control samples (Sterile).

• Validation: Plan and execute all critical validations, including Clean Room, Sterilization (ETO and Gamma), and Sterile Barrier Packaging validations.

• Environmental Monitoring:

  Execute comprehensive Environment Monitoring (EM), manage Fumigation, and maintain daily records for critical cleanroom parameters (temp/humidity, pressure difference).

• Lab Compliance & Documentation: Manage QC documentation, including BMR Review & Retention (Sterile). Maintain Culture stock and Media. Ensure timely Calibration of all lab instruments. Manage QMS per ISO 13485 and support Audits/NCR Closing.

• Administration: Handle purchasing for lab supplies and provide test reports as needed. Initiate improvements via Change Notes.

Qualifications & Skills

• Education: Bachelor’s or Master’s in Microbiology or a related life science field.

• Experience: 2 to 3 years of relevant experience in QC Microbiology, preferably in Medical Device/Sterile Manufacturing.

• Technical Skills: Proficiency in aseptic techniques, sterility testing, and microbial identification.

• Soft Skills: Excellent attention to detail, strong documentation skills, and effective communication.

Additional Prerequisites

• Strong working knowledge of ISO 13485 (Medical Devices QMS) and Good Manufacturing Practices (GMP).

• Must be proficient in the technical requirements and execution of:

  1. ETO Validation

  2. Gamma Validation

  3. Clean Room Validation protocols.

Benefits

• Provident Fund (PF)

• Paid Time Off (PTO)

• Paid Sick Time

• Leave Encashment

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