Quality Assurance Regulatory Affairs
Resume:
SAYALI TAMHANE
720-***-**** **************@*****.*** LinkedIn: https://www.linkedin.com/in/sayalitamhane SUMMARY
● 8 years of diverse experience working in pharmaceutical Industry (Regulatory Affairs, Quality Assurance & Compliance and R&D.). I bring forward proficiency to perform effectively in a cross-functional industrial setting. Highly knowledge and experienced in Gxp and regulatory requirements. AREA OF INTEREST
Quality Assurance
Project Management
Regulatory Affairs
Quality management System
PROFESSIONAL EXPERIENCE
Batch Record Reviewer Granules Pharmaceutical Inc. Chantilly, Unites States. Oct 2022– Present.
Reviewed and approved batch production records to ensure compliance with Good Manufacturing Practices (GMP), company policies, and regulatory requirements.
Identified and addressed discrepancies in batch records, collaborating with production and quality teams to resolve issues promptly.
Verifiy critical process parameters, in-process testing data, and final product specifications to ensure product quality and compliance.
Regulatory and Quality Compliance Specialist TraceLink Pune, India Aug 2021 – Jan 2024
Streamlined organization’s Quality Management System to comply with industry and federal and global regulations (21 CFR 11, ISO 9001, GxP), and corporate strategic goals.
Enhanced the eQMS system including user management, user training, periodic review, change control, document management, records management, good documentation practices, tool qualification, and improved use.
Developed and delivered training programs for different departments and administered the Learning management system.
Maintained the eLMS system including user management, content management, and compliance reporting.
Conducted internal quality audits of the organization, including quality system inspection and reporting for areas documented in the internal audit schedule.
Performed vendor reviews in support of the Vendor Management program.
Supported hosting of customer audits and provided responses to customer audit reports.
Involved in ISO certification work and audits.
Executed Corrective and Preventative Action (CAPA) and Deviation management work, as assigned; and collaborate with department managers to address and manage CAPAs and Root Cause Analysis documentation to ensure customer satisfaction and process improvements, risk management processes and improvements.
Assisted in SDLC, application releases, and qualification documentation work including validation.
Generated reports of Key Performance Indicators, data metrics, objectives, and goals. Regulatory Affairs Specialist, Covance Company, Pune (For Johnson & Johnson) Pune, India Apr 2018 – Jul 2021
Worked on Module 3 (Quality) of eCTD / Dossier preparation: o Creating, updating and managing stability protocols, stability studies, specifications, stability statements and work instructions related to drug products and drug substances. o Responsible for preparation and peer review of scientific protocols, reports for activities like Annual Quality Review (AQR), Product quality review (PQR) o Preparation of Module 3 documents for dossier and eCTD filling. o Extraction, review and accurate interpretation of data from various database location (eg. SAP, eLIMS, Trackwise, Docspace, Sharepoint, Veeva RIM) o Have experience in creation, review and approval of analytical stability reports and submission to US FDA / different regulatory agencies.
o CAPA Support, Regulatory technical documentation. o Involved on module 3 documents preparation of drug substance and drug products. o In-depth knowledge of Chemistry Manufacturing and Controls (CMC) that describes physical, chemical or biological characteristics, manufacturing controls and testing information of drug substances and drug products.
o Have experience of dealing with clients and their requirement on daily basis. o Managing data in eLIMS, Trackwise, SDMS
o Preparation and submission of biweekly dashboard and presentation to higher management.
Worked on quality compliance of different drug substance and drug products: o Handling portfolio of different drug products and drug substances and managing their overall stability life cycle.
o Creating, managing and approving different change controls records and quality investigations records necessary for drug products and drug substances in trackwise. o Involved in audit meetings related to stability testing and reporting of drug products and drug substances at different
o plant sites.
o Impact assessment for temperature excursions, quality investigations and assessment finalization.
Research Associate, Lupin Research Park, Pune, India Apr 2017-Apr 2018
HPLC and UPLC System (Waters, Agilent, Schimadzu & Dionex) o Working on Empower-3, chromeleon.
o Handled different types of instruments required in formulation research and analytical development. ( PSD and XRPD method development .
o PDR Data compilation, development report and assistance in CTD Dossier Preparation.
o Working in USFDA Quire Group. .
o Fulfillment of Regulatory Requirements.
o Managing data generated by analytical instruments. o Stability testing as per ICH guidelines.
o Preparation of validation reports.
o Good Documentation of each trial and routine analysis o Preparation and review of SOP
o Spreadsheet Validation.
o Forced degradation study as per Brazil guideline. o Method equivalency study.
o Performed beverages study.
Research Associate, Sai Life Sciences, Pune, India Sepr 2015-Apr 2017
HPLC and UPLC System (Waters, Agilent, Schimadzu & Dionex) o Working on Empower-3, chromeleon.
o Handled different type of instrument required in formulation research and analytical development
o PDR Data compilation, development report and assistance in CTD Dossier Preparation.
o Working in USFDA Quire Group.
o Supporting seniors in Method development.
o Fulfillment of Regulatory Requirements.
o Managing data generated by analytical instruments. o Stability testing as per ICH guidelines.
o Preparation of validation reports.
o Good Documentation of each trial and routine analysis o Trouble shooting in routine analysis.
o Preparation and review of SOP
o Spreadsheet Validation.
o Forced degradation study as per Brazil guideline. o Method equivalency study.
EDUCATION
Master in Pharmaceutical (Quality Assurance Department), University of Pune Year: 2013-2015 Bachelors of Pharmaceutical, University of Pune Year: 2009-2013 TECHNIQUES, TOOLS AND SOFTWARE
Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), cGxP, ICH
Corrective and Preventive Action (CAPA), Root cause Analysis, KPI Metrics, Risk assessment
Electronics common technical document (eCTD)
ELIMS, SAP, Trackwise, Truvault (Veeva Vault), MS Office Suite, Cognition Cockpit, JIRA, ZENQMS, Litmos Document Management, Document review, Document Authorization (white paper)
Project coordination, Customer support, Client delivery, Client relation, stakeholder management FDA Regulation (21 CFR part 11, 21 CFR Part 820)
Validation(Analytical method validation, Instrument validation and Computer system Validation) ISO 9001:2015, ICH Guidelines
Statistical Models for analytical method development and QMS
Regulatory Compliance, Document Management, Project co-ordination
Risk Assessment
Quality Management System
FDA Regulation
Validation(Analytical method validation, Instrument validation and Computer system Validation) ISO 9001:2015, ICH Guidelines
Statistical Models for analytical method development and QMS ACHIVEMENTS
Developed and implemented a training program for new employees resulting in 25% reduction in onboarding time and improved productivity.
Involved in setting system for Internal Audit program and was recognized for the work as it helped for smooth flow of Audit
Completed documentation of the urgent regulatory timeframe before time for an ADHOC request which was recognized by client.
CERTIFICATIONS
Internal Auditing Basics by ASQ
Practical Regulatory Affairs 2020-EUR MDR by Udemy
European Medical Device Regulation in simplified way by Udemy
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