Quality Assurance - Post Marketing Surveillance

Ashish Patel

******.*****.***@*****.*** Birmingham AL

SUMMARY

Quality professional with experience in the medical device & pharma industry, applying expertise in regulatory compliance to implement, manage, and support quality system improvement and remediation initiatives. Subject matter expert utilizing nursing background to work on post-market surveillance, quality assurance, compliance and regulations, risk management, design controls, manufacturing, change control, verification and validation. Expertise in global regulatory requirements and standards: 21 CFR Parts 11/803/806/820/822/830/860, MDD, EU MDR, ISO 13485/14971/14155, ICH Q9 and GxPs.

Seasoned quality and validation professional with nursing background experiencing in Pharmaceuticals and Medical devices industry with focus on post market surveillance (complaints handling), vigilance, MDR (medical device reporting), quality assurance, compliance and regulations with functional areas includes CAPA, Change Control, Risk Management, Product development per Design controls and ICH Q9/Q10, Managements controls, Manufacturing GxP support.

Experienced in cGMP, GDP, ISO 13485, FDA CFR Part 210, 211 & 820, ICH Q9, Q10, GLP, EU MDR, and other regulatory standards

Hands-on experience Sending data of product complaint cases to Global manufacturing sites in a timely manner and edit narratives written by Analysts and ensure case is correct before sending to manufacturing sites

Trained on all new products released as well as new procedures for existing products and Attached any necessary documents to Drug Safety and Product complaint cases

Responsibilities within the division of Global Clinical Safety and Pharmacovigilance (GCS&PV) span safety content in medical devices and combination products (MDCP), supporting various combination products including risk management, hazard analysis, use-risk assessments, human factors engineering, protocols, reports and approvals; SME of US and European Union (EU) regulatory safety regulations/content for Clinical Evaluations, and Reports (CER), Plans (CEP), & Drug Delivery Devices

Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints Interfaces with Corporate Quality Engineering and the manufacturing sites as required for product complaint investigations/trends

Remediated technical files to ensure compliance to EU MDR. Ensures that principals of Design Control are applied to product documentation.

Hands-on experience in using electronic Quality Compliance Systems per 21 CFR part 11. Systems includes Windchill, SAP, Trackwise, Master Control to review and route documentation needed to fulfill document management requirements.

Document daily operations in GMP batch records and logs following written and electronic instructions in SOP.

Responsible for remediating Design History Files for products for compliance with internal quality system procedures and 21 CFR Part 820 quality systems regulations

Performed analytical runs data and manufacturing batch records including formulation packaging and labeling review; Laboratory OOS, OOT root cause investigation (RCI), GAP and PQA / CAPA assessment, investigation, root cause analysis and remediation; GxP quality system assessment.

Expert in Trackwise OOS/SCAR investigations, GMP auditing of parenteral/IV filling/finishing/packaging operations, approve packaging according to configurations, supplier quality, batch record review, FDA readiness oversight and related QMS related activities

Software Skills: Pilgrim Smart Solve, Oracle Argus applications, TrackWise (Sparta Systems); PTC Windchill, SAP, ARISg, Argus, MedDRA coding, PubMed, SalesForce, Cognition Cockpit, Customer Relationship Manager (CRM)/SAP, PTC Windchill, Pilgrim (Smart Solve)

Quality Skills:

21 CFR (803, 820, 211, 210)

GMP, GLP, GCP, GDP – GxP

CAPA, Failure Investigations

IQ, OQ, PQ - Validation

Track wise, Documentum

Complaint Handling and Investigation

Complaints coding, IMDRF, MEDRA, MedWatch FDA, Vigilance

Veeva Vault, Track wise, Master Control, SharePoint

ISO 14971 (Risk Management, Devices)

ICH Q9 & 10 (Pharma Risk Management)

QMS, ICH, EUMDR

SAP, Oracle, Argus, SQL

MS-word, MS Excel, MS Access

Professional Experience:

Siemens Health Care Diagnostics, Tarrytown, NY Feb 2021 to Present

Quality Assurance - Post Marketing Surveillance

Provided Quality Systems support including complaints handling, CAPA, risk management, change control & design controls change projects for Global Quality System under the corporate guidelines.

Responsible for product returns and evaluating alleged product defects in relation to patient risk, customer focus.

Established preliminary root cause, failure analysis and defined scope of reported issue.

Worked collaboratively with Field Safety Corrective Action team for product containment and recalls.

Handled, compiled complaint handling database of Post Market Surveillance department, performed trend data analysis metrics/reporting and conducted complaint investigations for MDR, MDV reportable complaints.

Drafted and completed Post Market Surveillance (PMS) reports on yearly basis.

Reviewed thoroughly completed complaint investigations, which includes review of DFMEA, DHR, repair records and manufacturing documentation.

Worked with PMS team members on complaint coding, medical terminology and MeDRA coding & coding of adverse events using MedDRA, IMDRF

Performed case book-in, case delete, case undelete, duplicate check, data entry & quality control valid case information into the Oracle Argus software.

Collaborated with cross-functional teams within complaints, R&D, Regulatory Affairs, Sales and Supplier Quality as necessary to achieve thorough and accurate complaint evaluations.

Identified investigation solutions for product documentation consistency and process specification related issues.

Revised procedures, processes as needed to increase the efficiency and regulatory requirements compliance.

Evaluated safety complaint escalations.

Assists with review of the timely coding of completed complaint investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure

MDR reporting to regulatory bodies, authorized representatives or regional units.

Coordinate with Headquarters Support Center (HSC), the Designated Complaint Handling Unit (DCU) and Medical Affairs to review and assess and close potentially adverse events.

Provide support in all areas associated with MDR/MDVR/MDPR, trending and Field Corrective action decisions.

Supporting R&D & Manufacturing with activities involving transitioning MDD to EU MDR compliance.

Reviewed, evaluated, and updated PFMEAs, DFMEAs, AFMEAs, Risk Management Plans, Risk Management Reports, Risk Management Files and Design Requirement documents to ensure MDD and EU MDR compliances

Participated in developing risk management files (risk analysis & FMEA), performed design controls from design inputs to verification & validation, according to 21 CFR 820, ISO 13485 and ISO 14971 quality standards

Reviewed risk management files, Device History Records (DHR) for products during complaint investigation

Participated in CAPA and Non-conformance investigations, PMS Complaints, Process &Production, Change management, Design controls & risk.

Reviewed and evaluated CAPAs associated with non-conformance and regulatory audits.

Fresenius Medical Care, Waltham, MA Dec 2019 to Jan 21

Quality Engineer – Post Market Surveillance

Assisted Risk Management team by authoring CERs and providing risk reviews to identify hazards and hazardous situations, to validate controls, and to ensure post mitigation safety;

Assisted with review of the timely coding of completed complaint investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure

Performed queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints

Performed clinical investigations to support ADE/MDR regulatory submissions after review of medical records, complaint files, and or medical journals for death and serious injury cases;

Researched drug, device, and patient information received from health care professionals regarding harm or potential harm to a patient by a manufactured drug or device, and determines if complaint represents an event that is reportable to the FDA based on FDA and reporting requirements;

Compiled data, generates and submits MDR/ADE reports to the FDA as required;

Evaluated complaints for Field Action Reporting (FAR), severity level, FDA coding, and Health Hazard Evaluations;

Created Change Controls for the implementation of enhancements to the Events and CAPA workflows.

Hands on review of the following deliverables - Regulatory Assessments, Risk Assessments, Post marketing surveillance reports, Management review slides on MDR reporting, workflow in TrackWise.

Conducted CAPA Investigations, identified Root Cause(s), Corrective Action Plan, Preventive Action Plan, Reviewed Risk Assessment, Implementation, Approvals, and VoE for CAPAs needing remediation.

Worked with CFT on several of the 483-observation quality system remediation CAPAs related to complaints as needed.

Monitored CAPA effectiveness and audit trending of quality data streams data and trending amongst various departments.

Reviewed, identified and remediated CAPAs for proper content (problem investigation, risk assessment, root cause, MDR, MDV reports, action plans, Device history records).

Technical Investigations – Root cause Analysis, CAPA resolutions, dFMEA, GAP analysis, DHR and DHF remediation.

Competent in Quality Systems and Standards (cGXP: cGLPs, cGCPs, and cGMPs) and Regulation of Drugs and Medical Devices.

Strong Technical Writing background with experience in drafting/issuing User Manuals, Business Requirements and Functional specification and well understanding of Configuration Specifications.

Proficient knowledge of 21 CFR Part 11 /Annex 11 (European Regulations) and partial knowledge of 21 CFR PART 11, 210, 211, 312, 314, 820.

TCS, India Feb 2017 to Sep 2019

Validation specialist

Responsible for writing and executing validation protocols, IQ/OQ/PQ, and validation reports around new mechanical and assembly equipment and processes.

Responsible for Validation/Qualification/Improvement of manufacturing processes to ensure all products are made with the highest possible quality within a lean manufacturing environment.

Involved in verification of Tech Reviews, PFMEAs, Process Validation Assessment Matrix (PVAMs) and Performed gap analysis on multiple products and their Design History Files (DHF). Reviewed documentation throughout the entire design life cycle

Demonstrated history of working in laboratory set-up involving Hardware Assembly and Testing of the product on the prototype level using voltmeters, oscilloscopes.

Performed gap analysis for – DHF (inputs, outputs & V&V) /Risk Files (risk analysis, FMEAs – Design, Process), EUMDR requirements and conducting Design change projects

Performed verification and validation(V&V) of User Interface (UI) of the Software Application.

Filing Device history records (DHR) for the pilot lot, Documented work instructions for a part of a product.

Education:

Master in Public Health in Health Behaviour at University of Alabama at Birmingham. (USA)

BSc. Nursing (Sumandeep Nursing) Sumandeep University (Baroda) INDIA

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