Hiring for A client of Sapwood Ventures
10 - 15 YearsHyderabad
Reporting to Head - AS
A) 10-12 years of total experience working in pharmaceutical/ Biotech companies in Microbiology dept (Quality control department). At least 5 years of experience by independently managing microbiology dept and also maintaining the lab as per international and local current regulatory requirements
B) Strong work experience in the area of microbiology analytical method development, validations and batch release testing as per USP/EP/BP
C) Have very good knowledge of MLT and sterility testing
D) Experience in analysis of total microbial count i.e. Total bacterial count and yeast mould counts for APIs/ Formulations (Tablets/ injections)
E) Experience in endotoxins test (LAL method)
F) Implementation of CGMP norms. Analytical Method validation for different APIs/ Formulations
G) Handling of Method validation Protocols and Method validation Reports
H) Implementation of the Standard Operating Procedures and Standard Testing Procedures.
I) Implementation of Calibration and Preventive Maintenance Schedule for various MICROBIOLOGY instruments.
J) Knowledge on the calibrations for various instruments like Balance, pH meter, Colony Counter, Incubators, Autoclave, microscopy etc.
K) Stability study for different finished products and APIs.
L) Managing of Stability Schedule for various APIs and finished products (Microbiology perspective)
M) Preparation of Culture Suspensions giving app. 100 cfu/ml for different organisms which are used in Positive Control tests as well as in GPT tests.
N) Carry out estimation of vitamin B12 by tube method & plate method
O) Microbiology support to stability studies
P) Managing maintenance and calibration of all microbiology equipments e.g., autoclave, incubators, microscope