Jayashree Mane
Business Process Lead at Tata Consultancy Services, SOP Manager - Global Quality Operations at Tata Consultancy Services
- Role
- Medico Marketing and Digital Marketing Consultant at Tata Consultancy Services
- Location
- Thane, IN
- LinkedIn followers
- 500 followers
About Jayashree Mane
13 years of experience in Clinical trials, Achievement driven professional, targeting asignments in field of pharmacovigilance, project management, Audit and inspection (CQA and IQMS) regulatory affairs, Sop management and Technical service with an organization of repute.
Experience
Medico Marketing and Digital Marketing Consultant
Feb 2025 — Present · Thane, IN
Jul-2021-Till Date - Project Leader, Project Record Custodian Quality check, Certified IQMS Auditor Medical reviewer: Managed and Lead processing team, ensure all the tasks performed as per the rules and standard guideline procedure. Connecting with clients and other stake holders for smooth collaboration and running of accounts. Project management and Medical review managed operational activities by local governance structure. Maintained oversight of quality, compliance, productivity delivery through a metrics-based approach, ensuring that agreed SLAs are met as per agreement. Drived and endorsed the implementation of process improvements and initiatives. Key thrust areas are enhancing the productivity and efficiency at site while maintaining consistent processes. Maintaining the regulatory standards and TCS SOPs for Drug Safety Operations. Proactive communication in case of deviation/ Risk of deviation to project QPPV and/or Customer leader. Certified internal trained auditor and have successfully conducted 2 IQMS Audits. Also played role of internal Auditee for project and successfully cleared (1 IQMS and 1 CQA) Audits with no critical NCs and finalized report in internal portal for TCA Quality Audit system (TQAS). CAPA oversight filling from internal audits. Supported in extracting clients PV system Master file (PSMF) relating to quality system and PV inspections. Quality check and Medical review of the ICSR in Argus Safety database As a project leader initiated continuous improvements in PV processes for which logged 3 ideas which implemented and registered in internal Impact portal.
Education
Brahman vidyalaya
Life-Science
2001 — 2010
University of Mumbai
Bachelor in Pharmacy
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