Soma Das
Head of Report Issuance || Drug Stability Management; Instrument lifecycle & Environmental Monitoring II Trending II Digitalization || Compliances, QMS, Lab set up || team building with Effective Leadership skill.
- Role
- Head of Report Issuance, m & s Services, Hyderabad Hub at Sanofi
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Soma Das
STRATEGIC PHARMACEUTICAL PROFESSIONAL20+ Years of Excellence Bridging Scientific Innovation with Medicinal AdvancementCORE EXPERTISEValidation & Qualification Leadership: Directed and mentored the Instrument life cycle management team while ensuring seamless alignment with global strategic initiatives and organizational objectives.Initial Qualification/ Requalification Processes / protocols / Risk assessments for instruments, equipment, software systems, and facilities in compliance with GxP/GLP standards while maintaining rigorous laboratory safety protocols.Supervised environmental monitoring study teams, trending and Digitalization.Technical review for stability method development and validation processes. Stability summary and trending.Led global teams in reference standard management and shipment coordination.Digital Innovation: Served as key contributor to site-wide Data Digital transformation initiatives.System Ownership: Managed critical applications with 21 CFR Part 11 compliance including DOCFOCUS (automated format reviewer); LIMS systems (Labware) and CDS (Chromeleon), creating significant efficiency improvements through data automation.Compliance Leadership: Designated as SPOC for GMP compliance and regulatory audit/inspection activities.Tracked and analyzed KPIs to drive team performance, consistently achieving or surpassing established targets.Global Quality Management: Demonstrated excellence in global operations with extensive experience in GMP/GDP frameworks and quality management systems, including deviation investigations, change management, CAPA implementation, effectiveness verification, and quality agreements.KEY ACCOMPLISHMENTSAppointed as Global Network Lead for instrument qualification and validation initiatives.Reviewer for critical GMP documentation including SOPs, work instructions, protocols, and reports aligned with global quality standards.Served as Subject Matter Expert (SME) and Single Point of Contact (SPOC) for compliance matters across multiple systems for critical laboratory systems and Instrumentations.Established productive cross-functional collaborations with Quality Assurance, Engineering, vendors, developers, and Global business stakeholders to ensure precise technical requirement validation.Played instrumental role in internal and external audit processes.
Experience
Head of Report Issuance, m & s Services, Hyderabad Hub
Aug 2025 — Present · Hyderabad, IN
Lead and manage the global report issuance activities, alignment with global strategies and objectives Oversee the qualification, stability management, and environmental monitoring teams, supervised by team managers Develop and implement strategic plans for the global report issuance hub, focusing on continuous improvement and operational efficiency Align global activities with policies, standards, and regulatory requirements Monitor key performance indicators (KPIs) and ensure that teams meet or exceed targets. Ensure that all report issuance activities comply with established internal quality standards defined by the global quality team and external regulatory requirements Implement and maintain robust quality assurance processes to ensure the accuracy and reliability of protocols and reports Foster a culture of continuous improvement, professional development, and teamwork within the regional hub Act as the primary interface between the regional hub and global leadership, ensuring effective communication and collaboration Maintain strong relationships with internal and external stakeholders to facilitate smooth report issuance processes Team availability regulatory inspections Manage global resources effectively, ensuring that teams have the necessary tools, training, and support to perform their roles and identify and address resource gaps to optimize team performance Drive continuous improvement initiatives within the global hub, leveraging feedback and best practices to enhance processes and outcomes Awareness of Industry trends to ensure the hub\'s activities remain compliant and cutting-edge.
Education
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2000 — 2005
D.A.V.Public school
Class XII, PCMB
1998 — 2000
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - BPharm, Pharmacy
St.Joseph's Convent High School
class X, ICSE
1998 — 1998
National Institute of Business Management (NIBM) Global
Master of Business Administration - MBA , Pharmaceutical Sciences
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