We are Galentic Pharma (I) Pvt. Ltd., Gandhidham, Gujarat, and we are hiring for the position of Microbiologist.
If you are interested kindly share your cv : 6357938032
Required Education : M.Sc in Micro
Required Experience : 3-6 Years in Micro Pharmaceutical
Responsibility :
1. Routine Quality Control and Testing
· Sterility Assurance: Conducting rigorous membrane filtration or direct inoculation to confirm that finished sterile products (e.g., injectables, eye drops) contain zero viable microorganisms.
· Bioburden Testing: Evaluating raw materials, active pharmaceutical ingredients (APIs), and in-process mixtures to quantify the microbial load before sterilization.
· Bacterial Endotoxin Testing (BET): Using the Limulus Amebocyte Lysate (LAL) test to detect pyrogenic (fever-inducing) bacterial endotoxins in parenteral products.
· Water and Utility Monitoring: Routinely sampling Purified Water (PW) and Water for Injection (WFI) systems for bacterial growth, including pathogens like E. coli and Pseudomonas.
2. Contamination Control and Cleanroom Management
· Environmental Monitoring (EM): Collecting air samples, surface swabs, and personnel contact plates within sterile manufacturing suites (cleanrooms) to ensure they meet stringent ISO/Grade classifications.
· Aseptic Process Simulation (Media Fills): Overseeing and validating the sterile filling process by substituting the drug product with nutrient media to ensure that operators and machinery can safely fill vials without contamination.
3. Validation and Process Control
· Sterilization Validation: Ensuring that autoclaves (steam sterilization), dehydrogenation tunnels, and other sterilization methods achieve the required level of microbial kill.
· Disinfectant Efficacy Testing: Validating that the chemical cleaning agents used in manufacturing facilities effectively eradicate local and standard microbial strains.
4. Research, Development, and Production
· Biotechnology Manufacturing: Utilizing genetically modified microorganisms (bacteria, yeast) to synthesize complex biological products such as insulin, human growth hormone, and certain vaccines.
· Antimicrobial Research: Studying microbial genetics and resistance to develop novel antibiotics, antifungals, and antiviral drugs.
5. Regulatory Compliance
· cGMP Adherence: Ensuring all testing and manufacturing processes align with Good Manufacturing Practices and regulatory guidelines set by bodies like the US FDA, EMA, and the WHO.
· Audit Support: Assisting during regulatory facility inspections and investigating root causes and implementing corrective actions (CAPA) if contamination events occur.
Pay: ₹20,500.00 - ₹35,000.00 per month
Benefits:
- Flexible schedule
- Health insurance
- Leave encashment
- Life insurance
Work Location: In person
