Urgent Required Microbiologist Leading Pharma (R &D Division)In Santej

We are expanding ( R& D) Department

Role & responsibilities

Pharmalab looking for an experienced and highly persuaded medical devices/ Pharmaceutical Microbiologist to join our growing research and development team. As a medical devices/Pharmaceutical Microbiologist, you will play a critical role in ensuring the safety and efficacy of medical device products through the analysis of microorganisms and their impact on product quality. If you are a detail-oriented and scientifically driven individual with a passion for microbiological studies, we encourage you to apply.

Essential Duties and Responsibilities.

• Assist in method validation for sterility, bioburden, bacterial and fungal identification and endotoxin of variety of invasive and non-invasive medical devices.
• Prepare microorganisms for identification and interaction with approved labs for analysis and identification.
• Perform in investigations related to sterility assurance and assist customer in devices sterilization during onsite qualifications and validation.
• Perform routine analysis of finished devices and its raw material according to established specifications and procedures relating to:
• Sterility
• Bioburden
• Endotoxin and Gramstain
• Growth Promotion
• Clinical trials
• Review and approve data related to sterility, bioburden, clinical trial data, and endotoxin testing of different medical and pharma products.
• Perform technical review of test results for completeness and compliance to cGMP to ensure that documentation, controls and traceability are in place to maintain integrity.
• We are hiring Only Female Candidate apply .

Preferred candidate profile :

• Masters or PhD Degree in Microbiology, or related field and 3-5 years of related working experience.
• Experience in a medical device manufacturing or pharmaceutical or biotech company.
• Hands on experience and expertise with a variety of bacterial organisms including aerobic and anaerobic microorganisms.
• Expertise with standard microbiological assays including colony forming units, optical density, total cell counts, colony morphology, cell morphology, etc.
• Aseptic technique, microscopic methods, and strain characterization experience
• Proficiency in microbial identification techniques, microbiological validation of medical devices and instrumentation.
• Strong laboratory skills, including experience with microbiological techniques and methodologies and DNA analysis of microorganisms.
• Experience with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Knowledge of regulatory requirements from agencies such as the FDA or CDSCO or MHRA or EMA.
• Competent to operate common computer programs Strong analytical and problem-solving skills, collect data, establish facts, and draw valid conclusions.
• Knowledge of ISO, ICH Guidelines and USP general chapters.
• Experience with regulatory submissions and inspections.