Job Description

You're an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That's why we would like to keep developing our company with you. Keeping your future in mind, we're making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.


Executive - Microbiology

Company:

Oyster Medisafe Pvt. Ltd.

Job Posting Location:

IN-Hyderabad

Functional Area:

Quality

Working Model:

Onsite

Requisition ID:

4204

Key Responsibilities:

+ Develop and implement hygiene protocols for personnel working in clean rooms.
+ Conduct regular training sessions on hygiene practices and monitor compliance.
+ Perform routine environmental monitoring of clean rooms, including air and surface sampling for viable and non-viable particles.
+ Validate clean room conditions and ensure they meet regulatory standards.
+ Conduct bioburden testing on raw materials, in-process samples, and finished products.
+ Analyze and interpret test results, ensuring they meet predefined specifications.
+ Perform sterility tests on medical devices to ensure they are free from viable microorganisms.
+ Conduct endotoxin testing on products to ensure they meet standards.
+ Maintain and manage positive control cultures for microbiological testing according to standard operating procedures.
+ Maintain detailed and accurate records of all microbiological testing and activities.
+ Investigate, analyse and implement necessary action for all OOS.
+ Must be able to verify and validate Microbiology test methods.
+ Ensure all microbiological activities comply with industry regulations and standards like ISO, CE, Indian Medical Device Rule 2017 etc.
+ Participate in continuous improvement initiatives to enhance microbiological testing processes.
+ Must contribute to Product and Process risk analysis team.
+ Supervise and mentor a team of microbiologists.

Qualifications:

Bachelor's or Master's degree in Microbiology. Minimum of [4-6 ] years of experience in microbiology within the medical device manufacturing or Pharmaceutical industry. Experience with regulatory audits and inspections. Familiarity with Good Manufacturing Practices (GMP) and ISO standards.

Knowlege and Skill Requirement:

Proficient in conducting bioburden, sterility, and endotoxin tests. In-depth knowledge of clean room monitoring, validation, and environmental control, Good Manufacturing Practices (GMP), ISO standards, and other relevant regulations. Ability to ensure all microbiological activities comply with regulatory requirements. Analytical skills on data analysis and problem-solving. * Proficient in report writing and strong communication skills.