AGM/DGM - Analytical R&D

Role & responsibilities

To be responsible for developing cost saving Analytical Methods by QbD approach test like Assay, RS, Dissolution, cleaning methods, and Method validation as per ICH guidelines for regulated market:

• To be responsible for qualification and characterization of API received for product development, API DMF review for compliance to regulatory market
• Sound knowledge of reverse engineering and establish Q1/Q2 for the products.
• Exposure in handling with QC tools for OOS, OOT, Investigations, root cause analysis, and effectiveness CAPA.
• To be responsible for verification and method transfer to the plant for the Excipients used in exhibit batches.
• To closely work with Regulatory Affairs (RA) Department for ensuring submission of data required for regulatory filing related to Analytical Development
• To be responsible for setting of specifications for finished products and excipients for new projects assigned to group.
• Ensures adherence to laboratory procedures, practices, and maintains and ensures upkeep of the laboratory equipment/instrument as per the GLP, EHS and other statutory guidelines.
• Trained the Scientists and Group Leaders efficiently offered overall Analytical thinking with excellent problem-solving skills.
• Competent to sophisticated analytical techniques like HPLC, UPLC, GC, PSD, XRD, Zeta Seizer DSC, LCMS, CAD, ELSCD detectors, DSD and other supportive laboratory instruments with complying 21 CFR regulatory norms.
• Well versed with ICH guidelines as well as understanding and evaluation of Nitrosamine, Elemental impurity assessment, Residual solvent assessment etc.

Location : Thane