Finished product testing and analytical method development by HPLC, GC, IC, UV etc.
Analytical method validation and transfers, analysis of API, Finished product R&D samples
How you’ll spend your day
Analysis of Solid oral dosage i.e. Dissolution, Assay, CU, BU and Related substances etc.
Analysis of samples received from Formulation department (samples include in-process, finished product, pre-formulation study samples and stability samples etc.).
To carry out analytical method development and method validation, in-process samples and finished products.
To carry out analytical method transfer activity to QC, Goa.
Handling and testing of hi-potent compounds/molecules
Trouble shooting of analytical instruments for difficulties faced during day-to-day operations.
Calibration and maintenance of analytical instruments. Maintenance includes activities such as Qualification, keeping track of AMC, History, Spares, Usage records etc.
Literature Search for development of analytical methods.
To ensure that all activities undertaken are executed in the framework of good laboratory and documentation practices and the existing quality systems are adhered.
To ensure safe practices are followed during the execution of activities and strict adherence to the EHS systems of the site.
Your experience and qualifications
M.Sc. / M. Pharm./ Ph.D.
4-8 Years relevant experience
Sound knowledge of Chemistry and analytical method development, method validation and transfer, Instrumental method of analysis and logical approach.
Hands on experience on Instruments viz., GC, HPLC, Ion Chromatography, UV and Dissolution apparatus etc.
Knowledge of regulatory requirements for different markets (US, EU, Canada etc.)
Knowledge on ICH guidelines, forced degradation studies, impurity profile etc.
Personal Attributes
Basic communication skills
Must be honest and trustworthy
Be respectful
Possess cultural awareness and sensitivity
Outgoing, personable, responsible, self-motivated and confident