Seema Shetty
Mumbai
Summary
An outcome-driven professional with 12 years of experience in QMS Handling, Quality Audit & Review, Training, Reporting & Documentation, Risk Management, Regulations and Team Management. Presently associated with Sanofi India Pvt. Ltd. (client based),Mumbai as Quality System Manager. Experienced in enhancing Quality culture and promoting Quality mind-set into the country governance, working principles and ways of operating. Proven expertise in assuring that country inspections of GxP or health-regulated areas are reported by the relevant GxP function in the appropriate company global database. Hands-on experience in maintaining an up-to-date local inventory and global database, together with relevant ITS functions, and local computerized systems in use within the country for GxP activities, are following the regulations and standards. A self-starter with skills in overcoming obstacles and the ability to work independently and on-the-move, manage multiple tasks, competing deadlines & priorities with minimal supervision
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality Assurance Manager
Syneos Health (Sanofi India client)
Mumbai
09.2018 - Current
- The role involves defining, implementing, managing, and controlling a Country Quality system for GxP/GDP, warehousing, distribution, and health-regulated activities in line with Sanofi quality documents and local regulatory requirements.
- The role involves leading a network of professionals in each country, managing country regulatory inspections, planning and managing information sharing, training sessions, and programs related to processes.
- The role also involves ensuring quality oversight of locally managed subcontractors and working as the focal point for proactive and reactive Quality Risk Management. The role also involves conducting qualification audits, following up non-conformances, facilitating internal and external audits, and tracking and closing warehouse-related complaints.
- The role also involves complaint management, providing trainings, conducting quality workshops, impact assessments, and implementing initiatives for audit readiness across the GxP/GDP third-parties
- Trained personnel on the use of new technologies or techniques designed to improve product reliability or safety standards.
- Established procedures and quality standards.
- Provided guidance on process improvements and best practices in order to maintain high levels of product quality.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
CQA Team Leader
Ciron Drugs and Pharmaceuticals Pvt Ltd
Mumbai
06.2014 - 08.2018
- Created & reviewed Specifications and Method of Analysis of Raw materials and Finished products & Packing materials considering AQL defects and Artworks as per current pharmacopoeia registered products.
- Reviewed records at plant level generated under of Deviation & Corrective and Preventive action Management, Change Control, Incident filing, Self-Inspection, Regulatory Audit Reports, and other relevant reports & results.
- Reviewed annual training planner, schedule and imparted training on guidelines, SOP, GMPro systems at all manufacturing sites and corporate level.
- Conducted Vendor audits of API and Excipients from our respective vendors, based on their facility & valid documents verified, qualified, or disapproved them to be as approved Vendor.
- Faced various audits including WHO audit, PIC/s audit, Regulatory audits for countries like PRP, Denmark, Ireland, Congo, Uganda, Kenya, Tanzania, Namibia, Zambia etc Majorly for Asia, Africa, Latin and Central America
Quality Control Officer
Bee Pharmo Pvt Ltd
Mumbai
03.2013 - 05.2014
- Prepared Standard operating procedures for testing and validating protocols (Pharmacopoeia and In House) related to microbiological testing, microbiological assays, Sterility testing and Preservative Efficacy test, Validation.
- Performed Microbial Limit Test (for Finished products) and various Microbiological Assays as per Pharmacopoeia requirements.
- Conducted Environmental Monitoring via Air monitoring for return duct and Settle plate method for operational areas at laboratory level.
- Dealt with NABL and ISO audits
Education
Master of Science - Biotechnology
CMJ University
Meghalaya06-2012
Bachelor of Science - Microbiology
GN Khalsa
Mumbai06-2008
Skills
- Internal Audits
- Operation Monitoring
- Quality Assurance Experience
- Quality Standards Determination
- Project Management
- Work Planning and Prioritization
- Risk Analysis and Mitigation
- Continuous Improvement
- Operations Management
- Personnel Training
- Documentation Review
- Complaint Investigation
- Relationship Building
- Document Control
- Performance Metrics
- Agile Methodologies
- Defect Tracking
- System Development
- Veeva,GMP pro,Phenix, QualiPSO, Service Now and Geode Tool Used
Accomplishments
- Received three accomplishments for "Play To Win" under category Think Organization Before Oneself and Stretch To Go Beyond in Sanofi India Ltd.
Certification
- ISO9001:2015 Quality Management System Auditor by Udemy
- Six Sigma Green Belt by Udemy
- The Complete Leadership Mastery Course by Udemy
- Computer Validation and Data Integrity by Compliance Trainings
- Pharma Drug Regulatory Affairs Certiificate course by Udemy
- Introduction to Regulatory Complaince by Udemy
Languages
English
First Language
Hindi
Upper Intermediate (B2)
B2
Marathi
Upper Intermediate (B2)
B2
Timeline
Quality Assurance Manager
Syneos Health (Sanofi India client)
09.2018 - Current
CQA Team Leader
Ciron Drugs and Pharmaceuticals Pvt Ltd
06.2014 - 08.2018
Quality Control Officer
Bee Pharmo Pvt Ltd
03.2013 - 05.2014
Master of Science - Biotechnology
CMJ University
Bachelor of Science - Microbiology
GN Khalsa
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