02 Oct
|
Zydus Medtech
|
Surat
02 Oct
Zydus Medtech
Surat
Senior Executive – Microbiologist (Heart Valve Project)Experience:3-8 years of experience in Microbiology, Sterility Assurance, Sterilization Validation, Environmental Monitoring, or Quality Control within Medical Device, Pharmaceutical, Biotechnology, or Healthcare industries. Experience in implantable cardiovascular medical devices, heart valves, tissue-based products, or combination products will be preferred. Required Skills & Experience Sterilization Validation (Liquid Chemical, EO)Microbial Identification Techniques Contamination Control Strategies Sterility Testing & Validation Bioburden Testing (ISO 11737)Bacterial Endotoxin Testing (BET/LAL)Environmental Monitoring Programs Cleanroom Monitoring & Qualification ISO 13485 Quality Systems Risk Management (ISO 14971)CAPA & Deviation Investigations Technical Report Writing & Documentation Statistical Trending & Data Analysis Regulatory Compliance & Audit Support Solid Communication & Cross-functional Collaboration Key Competencies Technical: Microbiological Testing & Analysis Sterility Assurance (Aseptic Handling)
Sterilization Validation Environmental Monitoring Contamination Control Risk-Based Thinking Root Cause Investigation Regulatory Compliance Data Trending & Interpretation Quality Systems Knowledge Behavioural: Strong Attention to Detail Analytical Thinking Problem Solving Team Collaboration Effective Communication Planning and Organization Accountability Continuous Improvement Mindset Decision Making Adaptability Qualifications and Experience: Master's degree (M. Sc.) in Microbiology, Biotechnology, Life Sciences, Medical Microbiology, or related discipline. Bachelor’s degree in microbiology, Biotechnology, Life Sciences, Pharmacy, or related field.3 to 8 years of experience in microbiology laboratory operations within regulated industries. Experience in sterilization validation, environmental monitoring, bioburden testing, and sterility assurance programs. Knowledge of ISO 11737, ISO 11135, ISO 11137,
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🏢 Zydus Medtech
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