Quality Assurance Risk Management

SANANDA CHAKRAVARTY

Canton MI ***** 989-***-****

***************@*****.*** linkedin.com/in/sananda-chakravarty Quality Assurance and Regulatory Compliance

Specialist in Medical Devices and Scientific Research Proven Leader in Multi-Project Management

Experienced Quality and regulatory compliance Specialist with over 4 years of expertise in supporting regulatory submissions, market access, and risk management for medical devices and Dietary supplements. Proficient in ensuring compliance with global standards (EU MDR, FDA) and managing the regulatory lifecycle of products from development through to post-market surveillance. Adept at coordinating with cross-functional teams, analyzing changes in regulations, and driving compliance across international markets. Strong background in regulatory documentation, labeling, and product lifecycle planning.

KEY COMPETENCIES

• Quality Assurance Expertise

• Regulatory Submission

• Labeling Documentation

• Project Management

• Scientific Research

• CAPA (Corrective and

Preventive Actions)

• EU MDR & FDA

Requirements

• Leadership Supervision

• Risk Management and

Mitigation

• Compliance and Audit

• Collaboration

• Communication

• Scientific Competence

• International registration and

UDI

• Ethical Work Practices

SIGNATURE ACHIEVEMENTS

• Successfully closed more than 15 changes/month including design changes.

• Completed external audit consecutively for last two years without any major finding

• Effectively completed IVDR/510K submission of developed products PROFESSIONAL EXPERIENCE

QIAGEN 2023 to Present

Quality Assurance/Design QA/Labelling SME/Change Management Represent Quality within cross-functional team, to coordinate documentation and ensure compliance for instrument. Collaborated with product development team to ensure designs, procedures and outcome of project are high quality. Experience managing multiple projects successfully.

• I have been actively involved in the preparation and submission of IVDR (In Vitro Diagnostic Regulation) and 510(k) applications, ensuring full compliance with FDA and EU regulatory requirements.

• Responsible for supporting and maintaining the technical files for medical devices.

• Monitoring Engineering Change Controls and Data trending to provide corrective action solutions that drive continuous improvement.

• Supporting creation and maintenance of comprehensive risk management plans, including dFMEAs, pFMEAs, and control plans, and conduct thorough investigations into manufacturing non-conformities and complaint handling activities, including intake, evaluation, investigation, and reporting.

• Participation in audits conducted by regulatory agencies for ISO 9001, ISO 13485 compliance. My responsibilities included audit scheduling, auditor training, root cause analysis, and implementing corrective actions to address findings.

• Overseeing the electronic document control systems like MasterControl for data retention and training records, in line with QIAGEN's policies and procedures.

• Proficient in using QIAquality (Salesforce-based software) for change control, CAPA records, and Nonconforming Product (NCP) management.

• In addition, I have strong proficiency in MS Office (Word, Excel, PowerPoint) and am quick to learn and adapt to new software tools.

• Label design and management using Bartender/LP4 software: Maintained with ISO standards, IFUs, SDS, Sticky labels, UDI, Intended use and risk classification of IVDR.

• Supports the preparation of materials for the Management Review.

• I have knowledge of ERP [ABAS] system for streamlining operations, maintaining accurate records of materials, equipment, and budgets.

BIOWELL LABORATORIES 2021-2023

Quality Assurance and Operation Supervisor

I have a strong focus on quality and a proven ability to apply a high level of integrity. Preparation of SOPs and update them time to time as directed by FDA/GMP. Documents management as per FDA 21 CFR 111. Product testing for microbial load as per USP 61/62/2021. HPLC for quality assurance.

• Review and audit labels based on standards and regulations

• Review the Certificate of Analysis for raw materials and finished products

• Certificate of free sale [CFS] ordering

• Batch Record Review: My expertise spans the management and review of Batch Manufacturing Records (BMR/BOM), ensuring proper preparation, issuance, completion, and approval while addressing discrepancies, deviations, and non-conformances. I am proficient in reviewing disposition and release certifications for batch records, as well as overseeing quality checks such as physical tests, disintegration, and dissolution, ensuring that product specifications are met.

• Oversees and tracks NCR, CAPA, complaints, and other related metrics to identify trends.

• Inventory management and logistics tracking by ERP.

• Training to new employees as per HACCP, follow the CAPA rules.

• Supported comprehensive quality record reviews, including but not limited to Design and Development documents, CAPA, NCPs, risk management, post-market surveillance, batch history records, calibration documentation, QC records, and labeling. ADDITIONAL RELEVANT EXPERIENCE

SAGINAW VALLEY STATE UNIVERSITY, Saginaw, MI 2016 – 2021 Research Associate with Dr. Dennis Gray Biological Department Highly skilled and results-oriented with years of experience overseeing laboratory operations. Proven expertise in managing and leading laboratory staff, ensuring compliance with regulatory standards, and driving continuous improvements in laboratory processes. Strong background in quality control, budget management, and health and safety compliance, with a track record of optimizing laboratory efficiency, ensuring the safe handling of materials, and maintaining high standards of quality and performance.

• Worked on Molecular Phylogenetics of ferns. Extraction of DNA/ RNA, Purification of nucleic acid by phenol-chloroform extraction, Gel electrophoresis.

• Supported or led research projects, including experimental design, data collection, and analysis, ensuring the accuracy and integrity of results.

• Managed daily laboratory operations, including scheduling, equipment maintenance, and ensuring a safe, efficient work environment.

• Managed the maintenance, calibration, and repair of laboratory equipment, coordinating inventory levels and ordering necessary supplies and reagents.

• Ensured the proper collection, analysis, and storage of data. Prepared and presented detailed reports for senior management and regulatory bodies.

• Synthetic media preparation, Bacterial cell culture maintenance, glycerol stock preparation, handling incubators and various instruments, reagent preparation, proper documentation, follow SOPs.

• Amplification [PCR] and analysis of Rbcl gene [Ribulose 1, 5 Bisphosphate Carboxylase]

• Phylogenetic tree construction using BLASTn, MEGA5.

• Synthesis of DNA from RNA [cDNA], Cloning, transformation, cDNA library preparation. SARDAR PATEL UNIVERSITY, Gujarat, India 2009 – 2015 Senior Research Scientist

Handling Multiple bacterial cultures, sterile cell cultivation, handling different parameters for incubator condition, media preparation/plate preparation with different types of nutritional or screening media as a part of Doctorate program at Bioscience Department in Molecular microbiology

• Reagent preparation, pipetting, sampling

• Bacterial growth & screening of selective species.

• DNA/RNA isolation & purification, DNA sequencing, PCR, RT-PCR.

• Next Generation Technology; Metagenomics.

• Physico-chemical characterization of wastewater [color, pH, total solids, chlorides, nitrates, phosphates, phenols, sulphate, COD, BOD, enzymatic test].

• Study on oxidative/ reductive enzymes.

• Sample preparation and analysis of wastewater by TOC analyzer, HPLC, FTIR, NMR and GC-MS.

EDUCATION

PhD (Microbiology, August 2009 to May 2015), BRD School of Biosciences, Sardar Patel University, Vallabh Vidyanagar, Gujarat, India on ‘Metagenome analysis to assess performance of activated sludge treatment plant and to improve treatment process at Common Effluent Treatment Plant’

M.Sc (Microbiology), June 2006- June 2008. BRD School of Biosciences, Sardar Patel University, Vallabh Vidyanagar, Gujarat, India

B.Sc (Microbiology), June 2003 – June 2006. N. V, Patel Science collage, Sardar Patel University, Vallabh Vidyanagar, Gujarat, India

Diploma, Certification Course Design and Interpretation of Clinical Trial, John Hopkins University

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