Girija V. Keny Robol

• Handling API replacement projects for Indian, EU markets.
• Handled Paediatric formulation in support to US market
• Handled trouble shooting projects for Liquid as well as solid oral dosage forms.
• Knowledge on preparation of solid oral dosage forms like Tablets and capsule and liquid dosage forms.
• Handled placebo preparation for various projects related to Nitrosamine support
• Indenting materials by raising purchase order, interacting with Vendors ,creating AED.
• Basic knowledge of QBD in formulation development for solid and liquid dosage forms
• Managing Periodic verification and calibration of equipments available in lab, creating performance verification schedule and following the same
• Indenting of material in SAP, interacting with Vendors, inspection of equipment & material.
• Handling Store for inventory of raw materials
• Handling harmonisation of excipients by paper base evaluation as well as raw material testing
• Knowledge for preparation of GMP documents like General manufacturing instructions, specifications, Stability protocol, Quality risk management document.
• Knowledge in preparation of Guidelines and SOPs
• Prepared Process verification protocol and reports
• Handling Internal audits.
• Knowledge in raising CAPA, Change control in QuoliPSO.
• Experience in performing of pre-formulation and Characterization of reference product.
• Monitoring stability data at different time points and compiling it. Compilation of dissolution data.
• Knowledge on handling equipment’s like Tablet Press – SVIAC, Fluid bed processor – Glatt GPCG 1.1, Coating Machine, Spray dryer, Capsule filling machine, Blister Packing Machine.
• Knowledge on SMS, successfully participated as SMS member at Production in Sanofi India Private limited
• Knowledge on HSE
• Knowledge on Lean management
• Computer Skills :

MS-Word, PowerPoint, MS-Excel, Power Bi

• Executed installation of cooling chamber
• Carried out performance verification of Hardness tester

• Worked under guidance of experienced professionals to learn best practices and techniques.
• Conducted inventory checks to ensure all materials were available for upcoming projects, preventing delays.
• Demonstrated eagerness to learn by asking questions and seeking clarification when necessary.
• Enhanced practical skills by assisting experienced professionals in various tasks.
• Adhered to company policies, procedures, and safety guidelines during daily work activities.
• Observed experienced professionals in action, gaining valuable insights into best practices within the field.
• Implemented suggestions from mentors, leading to enhanced productivity and skill development.