Microbiologist
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Vita Durare is looking for a qualified and experienced microbiologist to join our Quality team at Revive Medical Technologies (RMT). The Assistant Manager Microbiologist will oversee microbiological testing environmental monitoring and sterility assurance activities for medical devices.
Key Responsibilities:
- Perform and supervise microbiological testing of raw materials finished products water and environmental samples (including sterility bioburden endotoxin and microbial limit tests).
- Design implement and monitor environmental monitoring programs for cleanrooms and controlled areas (air surface and personnel monitoring).
- Analyze trends in environmental monitoring data and ensure timely reporting.
- Ensure full compliance with GMP GLP ISO 13485 and other applicable regulatory standards.
- Support internal and external audits including regulatory inspections (SFDA etc.).
- Prepare and review SOPs protocols validation reports and related documentation.
- Participate in method validation cleaning validation and sterilization validation.
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results perform root cause analysis and implement effective CAPA.
- Supervise and train microbiology lab staff while ensuring timely completion of all assigned tasks.
Qualifications & Experience:
- Bachelors or Masters degree in Microbiology or related field.
- 13 years of hands-on experience in microbiology within the pharmaceutical or medical device industry (experience in sterile manufacturing or cleanroom environments is preferred).
Required Skills:
- Strong practical knowledge of microbiological testing techniques and laboratory best practices.
- Good understanding of GMP ISO 13485 and regulatory requirements.
- Analytical mindset with excellent problem-solving and root cause analysis skills.
- Leadership and team management capabilities.
- Strong written and verbal communication skills with attention to documentation.
Work Environment:
- Role is based in a laboratory and cleanroom setting.
- Strict adherence to gowning procedures safety protocols and personal protective equipment is required.
To Apply:
Subject Line: AM Microbiologist Your Full Name
We thank all applicants for their interest. Only shortlisted candidates will be contacted
Required Experience:
IC
Key Skills
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