Pallavi Khanolkar

Pallavi Khanolkar Assistant Manager - Cipla Ltd Mumbai, Maharashtra-Innovative, ambitious, highly disciplined, and versatile professional with admirable career achievement and success. 14 Years' experience in various capacities in the Pharmaceutical industry. WORK EXPERIENCE Assistant Manager Cipla Ltd - 2012-06 - Present • Timely and periodic review of various documents during the complete cycle of Formulation product development (i.e from project kick off to Regulatory batch execution. • Product Literature Search • Preparation of Product Development Report (PDR for Regulated market (US, Europe) and International market (semi regulated market) used in the regulatory dossier submission. • Drafting response for the deficiencies received by the regulatory bodies on the submitted PDRs. • Review of Product development strategy, Technology transfer, Regulated batch documents (e.g Manufacturing guideline, scale up report optimization protocol/report, filter validation, Process validation, Hold time study, In use study etc). • Review of Quality by design document (QBD) document. • Preparation, review and updation of Formulation development SOPS, EOPS and IOPs. • Review of stability charts. Executive Corporate Quality Inventia Healthcare Pvt Ltd - 2009-03 - 2012-01 • Timely and periodic review and preparation of finished product and Stability specification for Domestic, SemiRegulated as well as Regulated market. • Preparation of sample Quantity lists for Tablets/Capsules, specification code list and maintaining the same. • Implementation of the specification through SCORE and DMS software. • Internal coordination with ARD, Site QC and Regulatory Dept. related to specification. • Modification of the specification as per amendment in Pharmacopoeia. • Timely provision of Effective version of specification to sister plant. • Raising and maintaining change control proposal. • To update specifications in SAP • Supervise, inform, motivate and allocate daily work to team members. • Handling of SAP software - QM Module R&D Officer Cipla Ltd - 2003-11 - 2009-01 • Evaluate and execute new and existing research strategies within organization and lead an independent team. • Demonstrate a high level of self-motivation, initiative and commitment required to champion R&D projects. • Actively participate in scientific research and project meetings to provide ideas and suggestions that support the mission and goals. • Have the flexibility to deal positively with concurrent projects and changing priorities. • Possess excellent interpersonal and organizational skills required for the supervision of projects within organization and across other functional disciplines, and with external collaborators on project-related issues. • Routinely evaluate established scientific techniques and approaches used in organization to push forward the boundaries of organization's laboratory. • Prepare results of the teams work for internal presentation or publications at a national or international level. • Supervise, inform and motivate team members. To ensure best practices prevail and motivate others within the team through empowerment and delegation. Interested in working in Corporate Quality / Clinical research / regulatory affairs Desired Profile: EDUCATION Post-Graduation Diploma in Clinico-Regulatory & Patents in PGDCRP Ruia College - Mumbai, Maharashtra 2008 Sophia College - Mumbai, Maharashtra 2003 B.Sc in Microbiology Bhavan's College - Mumbai, Maharashtra 2002 SKILLS DMS, Microsoft Office, MS OFFICE, SAP ADDITIONAL INFORMATION Software Knowledge: SAP, SCORE, DMS, Microsoft Office Suite