Health Care Quality Assurance

Puja Bhatt

( Sunnyvale, CA)-415-***-**** **********@*****.***

Professional Summary:

● Seasoned Quality Assurance and Compliance Lead with extensive experience in the biotechnology

,pharmaceutical, medical device and health care industries.

● Responsible with ISO9001, ISO 13485, ISO 14971, Track Wise, SAP, CALIFORNIA PROP 65, LIMS, Veeva and FDA.

● Knowledge and understanding of CMS,CLIA,HIPAA,OSHA,TJC and CMS to evaluate quality and patients safety.

● Experienced in managing ISO certifications, conducting internal and external audits, and driving continuous improvement initiatives.

● Skilled in handling Corrective and Preventive Actions (CAPA), Change Control, and Risk Management to maintain product quality and regulatory compliance.

● Experienced in implementing and maintaining cGMP, cGLP, and cGCP principles to uphold the highest standards in manufacturing and clinical site operations.

● Acted as the technical subject matter quality expert for all matters governed by GMP related regulations and guidelines as it relates to manufacturing, testing and controls.

● Demonstrated success in directing clinical trials, managing Quality Management Systems (QMS), and leading cross-functional teams to ensure compliance with regulatory requirements. Education:

UKA Tarsadia University, Bardoli, Gujarat, India

Master of Pharmaceutics (M. Pharm)

Pune University, Pune, Maharashtra, India

Bachelor of Pharmacy (B. Pharm)

Skills:

● ISO9001

● ISO 13485

● DMAIC

● ISO 14971

● CAR-T therapy

● Flow cytometer

● 21 CFR 11/820

● FMEA

● REACH

● RoHS

● CALIFORNIA PROP 65

● Vendor audits

● Small and Large molecular drugs

● Upstream and Downstream process

● LIMS

● Veeva

● eTMF

● Vendor/Supplier Audit

● Prodigy

● Familiar with Drug Metabolism studies

● Pharmacokinetics and Pharmacodynamics (PKPD)

● MS Office proficiency.

Certifications:

● CPHQ (Certified Professional Health Quality) – In process

● ISO 9001 Lead auditor – BSi Auditing Services

● Lean Six sigma Global Black Belt-2022

● Pharmacology-Drug Discovery and Development-/clinical trial Harvard University 2023

● Certificate of Regulatory Affairs on Drugs and Medical Devices from Raps – 2020

● Pharmacy Technician (California State and National Certificate) – In 2014 (Currently Renewed) Professional Experience:

Sartorius – Fremont, CA Aug 2022 – Present

Quality Assurance and Compliance Manager

● Implemented and maintained cGMP, cGLP, and cGCP principles to ensure FDA the highest quality standards in manufacturing and Clinical site.

● Directed and coordinated Clinical Trials activities, ensuring protocols were followed and data integrity was maintained in order to manage the effective QMS system.

● Conducted QA review of GLP reports, Schedules and/or delivers yearly GCP training for internal staff.

● Identified opportunities for process and system improvement and enhancement to better meet quality targets by handling green belt and Black belt projects.

● Lead the Supplier / Vendor Audit and related activities to manage effective quality materials for the process.

● Developed external GXP vendor relationship for advancement of clinical development program.

● Negotiated budget and payment schedule for GXP vendor, and request proposal budget for outsourcing vendor.

● Collaborated with Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) to ensure quality standards in outsourced activities.

● Provide the expertise to successfully managed clinical trials throughout phase I, II, III.

● Managed Chemistry, Manufacturing, and Controls (CMC) processes, ensuring compliance with regulatory requirements and industry standards.

● Collaborated with CROs/vendors to provide leadership and strategy for Product Quality and Risk management

(PQRM) guidance.

Miltenyi Biotec – San Jose, CA Aug 2020 – Aug 2022 Quality improvement Program Manager (with health care/clinic)

● Coordinated review of protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.

● Lead the planning and operations of quality management programs, addressing complex business, regulatory, and technical challenges within the healthcare environment.

● Evaluate and assess hospital programs, policies, and procedures to identify opportunities for improvement. Develop and implement alternative solutions, ensuring compliance with healthcare standards and regulations.

● Monitor and analyze performance trends, advising on corrective actions and developing recommendations to meet or modify program goals and hospital-wide quality objectives.

● Represent quality management functions within the hospital, working closely with departments and leadership to ensure alignment with institutional goals with respect to federal, state and JCAHO compliance.

● Commit resources and provide ongoing information, support, and training to departments and staff, enhancing the overall quality management system.

● Manage the outreach strategy, including building and maintaining strong relationships with healthcare professionals, regulatory bodies, and external stakeholders.

● Collaborated with department heads to ensure seamless integration of quality improvement strategies across all hospital units to support QIRM .

● Contributed to the development of compliance programs and trained staff on hospital regulations and procedures, improving hospital-wide adherence to standards.

● Participated in quality improvement in health related settings, including performing root cause analysis, Plan Do Study Act methodology and monitoring/analyzing improvement, program development.

● Provided Knowledge of Medicaid principles and practices with emphasis in quality improvement.

● Proven ability to design and execute strategic plans for continuous improvement initiatives. Wedgewood Pharmacy Manufacturing – San Jose, CA Jan 2017 – Aug 2020 Quality Assurance GXP Trainer

● Reviewed Master Production Record (MPR)/Batch record review and Quality Control (QC) data activities, ensuring accuracy and compliance with cGMP.

● Reviewed IQ, OQ, and PQ validation processes met required standards.

● Managed ISO 9001 and ISO 13485 certification processes, ensuring continuous compliance with cGLP/cGMP.

● Performed lot disposition activities, reviewing Certificates of Conformance (COFC) and Certificates of Analysis

(CofA) for products based on cGMP/cGLP.

● Reviewed SOP for all components, drug product containers, closures, packaging, labeling, in process materials, and finished product.

● Lead continuous improvement initiatives to optimize performance, provide KPI (Key Performance Indicator) and track the support improvement for annual merit analysis report.

● Conducted comprehensive internal and external audits to validate adherence to quality standards and regulatory specifications based on cGMP/cGLP.

● Implemented and managed Corrective and Preventive Actions (CAPA), Change Control Request (CCR), SCAR

(Supplier Corrective Action Requests), Deviation, PNCR and NCMR (Non-Conforming Material Reports), Out Of Specification (OOS/OOT) processes to address quality issues.

● Managed and ensured the quality of both small and large molecular products, overseeing adherence to stringent regulatory requirements for upscale and downscale processes. Santa clara Valley medical center/CVS– Sunnyvale, CA Apr 2014 – Jan 2017 Patient coordinator /inpatient pharmacy tech

● Entered patient medication orders into the pharmacy computer system, operated automated compounding and dispensing machines for preparation and storage of medications under the direct supervision of a pharmacist.

● Responsible for maintaining pharmacy inventory by validating pharmaceutical stock to determine inventory level.

● Expertise in insurance billing and also handling of Medicare/Medical insurance claims.

● Prepared and calculated dosage for pediatrics to reconstitute meds. Gufic Pharmaceuticals- India Feb 2010-Feb 2014

Clinical Pharmacist Intern (PV)

● Anticipated in clinical programs,continually kept updated with clinical guidelines, standard of practice to create new and update existing clinical policies .

● Reviewed PV-related deviations, quality issues, CAPA, effectiveness checks, and root cause analysis.

● Provided support in developing and revising pharmacovigilance SOPs, work instructions, and training materials to ensure regulatory alignment and best practices adhered with cGCP.

● Performed routine follow-up and timely reporting/submission of safety information from various sources, adhering to SOPs and regulatory requirements.

● Reviewed CRO compliance through various reports and oversight activities, including tracking KPIs, metrics, and QC of SAE/ICSR cases in the safety database.

● Undertaken other activities as needed or as requested by the supervisor.

*References will be available upon request.

*US citizen/Not requiring visa sponsorship

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