Development experience in supporting pre-formulation, preclinical and late phase functions in generics as well as NCE.
- Expertise in Analytical method development and Validation study for different types of dosages formulations (Tablets capsules, Syrups, Injections, ophthalmic preparations, Topical Foams, Liposomes.
- Extensive experience in Instruments viz., XRD, Thermal technique, Microscopes, Chromatography etc.
- Experience in setting up of tab as per GMP/GLP Environment with developing own procedures of for qualification and validation of equipment (IQ/OQ/PQ), and Lab Life Cycle Management (LLCM).
- Deft in managing R&D and Quality functions for developing new products.
- A keen planner & strategist with proven abilities in image/ brand building, growing & managing professional associates and client relationships.
- To provide analytical expertise to establish product operations.
- To initiate optimization and execution of analytical procedure and specification modification to meet regulatory requirements.
- Functioning inadequately to trouble and solve difficult technical problems
- Responsible to guide investigation studies performed at manufacturing facility.
- To initiate and evaluate method development validation and transfer.
- Responsible for compliance with good scientific practices and regulatory guidelines.
- Analytical activities for completion of pharmaceutical development as per the scope / country's requirement.
- Responsible to provide technical solution and to resolve the analytical issued arrived at commercial facility to move the commercial activity smoothly.
- Managing analytical development activities like supervising team members to design, plan, perform, interpret and report results of scientific experiments.
- Efficiently and effectively planned and execute quality system, operations procedures as well as GMP Guidelines in order to ensure internal / external audit compliances.