Job Description
- Experience in Formulation analytical method development, qualification/validation of analytical methods, stability study, forced degradation, wet analysis etc.
- Should have working knowledge on writing method development reports, addressing regulatory queries on ANDA related to analytical methods.
- Should have working knowledge on writing method development reports, addressing regulatory queries on ANDA related to analytical methods.
-- Devise strategies for analytical method development.
- Responsible for method validations.
- Dexterous in performing finished product complete Analysis of dosage forms-Solid, Semisolid and foam dosage forms.
- Preparation of the SOP's and STP's, Analytical method validation protocols and Reports, Method development reports.
- Sound understanding of developing method of analysis using various modules of HPLC with different softwares.
- Undertaken routine analysis (Assay, Dissolution, Related substances, InvitroStudy, Content uniformity & physical parameters) for formulation development (Both initial & various stability) samples.
- Knowledge on Validation and ICH Guidelines.
- Compile the data according to Guidelines and Assay and content uniformity of Routine & Stability Batches, optimization of in-vitro dissolution of formulation.
- Determination of moisture content of sample.
- Responsible for method validations.
- Dexterous in performing finished product complete Analysis of dosage forms-Solid, Semisolid and foam dosage forms.
- Preparation of the SOP's and STP's, Analytical method validation protocols and Reports, Method development reports.
- Sound understanding of developing method of analysis using various modules of HPLC with different softwares.
- Undertaken routine analysis (Assay, Dissolution, Related substances, InvitroStudy, Content uniformity & physical parameters) for formulation development (Both initial & various stability) samples.
- Knowledge on Validation and ICH Guidelines.
- Compile the data according to Guidelines and Assay and content uniformity of Routine & Stability Batches, optimization of in-vitro dissolution of formulation.
- Determination of moisture content of sample.
Company Profile
Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries. Biocon has the defining science, world class capabilities and a focused vision to deliver the promise of innovative and affordable medicine to a waiting world. Today, Biocon together with group companies employs more than 5000 employees with approxmimately Rs 2500 crore turnover and is expected to grow further during the current financial year .
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