Sanika Jadhav
Mumbai
Summary
I am a dedicated Quality and Regulatory professional with a robust 4-year track record in the dynamic fields of medical devices and in-vitro diagnostics. Armed with a post-graduate degree in Bioanalytical Sciences, I have cultivated a deep understanding of both the technical intricacies and regulatory frameworks essential to this specialized industry.My expertise is further underpinned by prestigious certifications, including ISO 13485:2016 Internal Auditor and Lean Six Sigma Green Belt. These credentials highlight my commitment to upholding the highest standards of quality management and process efficiency, crucial for ensuring compliance and enhancing operational excellence within healthcare settings.
Throughout my career, I have successfully navigated multifaceted responsibilities spanning quality assurance, regulatory adherence, rigorous auditing practices, complaint handling and strategic process optimization.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Sr. Executive - QA & RA
Transasia Bio-medicals Limited
02.2023 - Current
- Manage Customer Complaints for fully automated and semi-automated biochemistry analyzers and clinical chemistry reagents across India, Europe, and Russian markets. Record, initiate investigations, implement corrective actions, ensure closure of complaints, manage CRM, and coordinate with internal and external stakeholders for effective customer communication.
- Provide strategic insights to the global team based on customer claims from export markets. Fulfill global requirements by chairing monthly Quality calls between Erba Transasia and Erba Lachema Quality teams, facilitating updates, action plans, and brainstorming sessions on existing quality issues.
- Coordinate with Cross-Functional Teams to drive quality enhancements, overseeing the development and implementation of streamlined processes.
- Plan and execute strategies to continuously improve Mean Time Between Failure for Biochemistry analyzers. Conduct Pareto analysis for highly replaced components, manage team for analysis of field return defective parts, circulate key findings and action plans, and implement improvements approved by management.
- Develop and deliver comprehensive management reports, including Weekly Out-of-Box Failure (OOBF) updates and Monthly Quality MIS report, providing strategic insights for decision-making.
- Support verification and validation activities of newly developed products prior to launch.
- Implement safe launch processes to ensure successful product introductions in India market.
- Collation and submission of applications for licenses and certifications for manufacturing, sale, and distribution across all Transasia entities in India and overseas.
- Manage the WHO Pre-qualification project for lateral flow assay (rapid) test kits, ensuring compliance with global standards.
- Conduct internal quality audits to identify areas for improvement, ensuring adherence to internal protocols and industry standards and facing external quality and regulatory audits
Sr. QA/RA Executive
Accurex Biomedical Private Limited
01.2022 - Current
- To plan, direct and coordinate for regulatory compliances and strategies in the organization and with regulatory authorities and government officials for regulatory compliances
- To face all the external or third-party audits
- Vendor assessment and required audits
- Complaint handling
- Non-conformance handling and CAPA
- Conducting internal audits in the organization and liaison with all the department heads for compliances
- To maintain control over the organization's QMS and identify areas of improvement
- Recruitment of technical staff in the department as and when required.
QA/RA Executive
Levram Lifesciences Private Limited
07.2020 - 12.2021
- To assist Head QA/RA in all the regulatory affairs tasks
- Preparing and maintaining technical files and quality documentation
- To participate in internal and external regulatory audits
- To assist Head QA/RA in CAPA and complaint handling.
Education
Masters in Bioanalytical Sciences -
G N Khalsa College, Mumbai
01.2023
Bachelors in Bioanalytical Sciences -
G N Khalsa College, Mumbai
01.2020
Certification
- Completed "Internal Auditor Course for ISO 13485:2016 Standard" from TUV SUD.
- Completed "Lean Six Sigma Green Belt "Certification Course from KPMG
- Completed "Medical Device Single Audit Programme (MDSAP) course" from TUV SUD.
- Completed Internal Auditor Course for "5S - Workplace Organization Method" from Quality Catalyst Private Limited.
Personal Information
Date of Birth: 03/12/98
Disclaimer
I hereby declare that the above information is true to my knowledge.
Timeline
Sr. Executive - QA & RA
Transasia Bio-medicals Limited
02.2023 - Current
Sr. QA/RA Executive
Accurex Biomedical Private Limited
01.2022 - Current
QA/RA Executive
Levram Lifesciences Private Limited
07.2020 - 12.2021
Masters in Bioanalytical Sciences -
G N Khalsa College, Mumbai
Bachelors in Bioanalytical Sciences -
G N Khalsa College, Mumbai
Similar Profiles
Smita PatilSmita Patil
Senior Manager Technical Services at Transasia Bio-Medicals Limited - Corporate OfficeSenior Manager Technical Services at Transasia Bio-Medicals Limited - Corporate Office
Ankeet DalviAnkeet Dalvi
Senior CRM Developer at Transasia Bio-Medicals Limited - Corporate OfficeSenior CRM Developer at Transasia Bio-Medicals Limited - Corporate Office
Shivraj Rangrao PawarShivraj Rangrao Pawar
Asst. Manager – Embedded Firmware Development (R&D) at Transasia Bio-Medicals Pvt. Ltd.Asst. Manager – Embedded Firmware Development (R&D) at Transasia Bio-Medicals Pvt. Ltd.
AAKASH SABALEAAKASH SABALE
Support Executive Service Engineer at Dak System IncSupport Executive Service Engineer at Dak System Inc
ROHAN SINGHROHAN SINGH
Client Advisor at GUCCIClient Advisor at GUCCI