Galentic Pharma
Gandhidham,
Gujarat
Microbiologist
Pay ₹20,500 - ₹35,000 a month
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.
Benefits: Flexible schedule Health insurance Leave encashment Life insurance
Work Location: In person
