PROFILE To pursue a challenging career in drug, and medical device regulatory affairs and

become a part of an esteemed organization where I can use my skills,knowledge and experience to contribute in DMRs, technical files, IND/EUD applications, CMC compliance, clinical study monitoring and ICH/GCP guidelines and project planning of the organization.

Puja Bhatt

QUALITY CONTROL ASSOCIATE /

MANUFACTURING TECHNICIAN

415-***-**** adkn0n@r.postjobfree.com Santa Clara, CA WORK

EXPERIENCE

QUALITY CONTROL ASSOCIATE/MANUFACTURING TECHNICIAN WEDGEWOOD PHARMACY MANUFACTURING JANUARY 2019 -PRESENT Release all components, drug product containers, closures, packaging, labeling, in-process materials, and finished product.

Sample and inspect materials per SOP to monitor factors which may affect product quality.

Prepare all samples for analysis at external laboratories. Maintain reserve samples of all active raw material lots and all finished product lots.

Monitor storage conditions of the manufacturing environment, materials and products.

Maintain document control through review, approval and issuance of SOPS, batch records, labels and other controlled documents. Review and retain all records associated with batch production, packaging and labeling.

Review laboratory testing of the finished drug product, such as environmental monitoring, microbiological testing, chemical testing and in-process testing. Identify adverse trends and recommend improvements. Communicate with production and shipping/receiving to ensure appropriate materials and supplies inventory are available, appropriately qualified, documented, and released for laboratory use.

Investigate and/or review deviations and OOS results. Support equipment calibration, equipment/utility/facility validation, and preventive maintenance.

Participate in reviews of process performance, product quality, and advocating continual improvement.

Comprehend SOPs, forms, operational GMP training and quality activities. Responsible for performing daily quality functions including: IN PATIENT PHARMACY TECHNICIAN SANTA CLARA VALLEY HOSPITAL, SAN JOSE JANUARY 2019 - JANUARY 2020

Enters patient medication orders into the pharmacy computer system, operates automated compounding and dispensing machines for preparation and storage of medications under the direct supervision of a pharmacist Compounded mixtures and ointments.

Affixed prescription labels.

Delivered medications to patient rooms and referred questions to the pharmacist or nurse.

Maintained patient confidentiality all the time

Knowledge of infusion setting which include compounding of chemo and non- chemo infusion in aseptic environment.

PHARMACY TECHNICIAN CVS PHARMACY, SAN MATEO, CA MAY - NOVEMBER 2014

SR. EXPERIENCED PHARMACY TECHNICIAN CVS PHARMACY, SUNNYVALE CA JUNE 2018 - NOVEMBER 2020

Provide friendly customer service at pickup and drop off area. Good knowledge about insurance and billing.

Good knowledge about HIPAA privacy.

Experienced in cash handling, credit card processing and other type of billing. Answered and screened the phone calls for pharmacist and other staff. INVENTORY SPECIALIST PHARMACY TECHNICIAN WALGREENS PHARMACY, MOUNTAIN VIEW, CA DECEMBER 2017 - JUNE 2018 Responsible for maintaining pharmacy inventory by validating pharmaceutical stock to determine inventory level, anticipating needed medications and supplies, placing and expediting orders and also removing outdated drug stocks.

Perform mathematical calculations for special dose preparation and compounding.

Well-vied in the operation and handling of automated dispensing devices. Accountable for preparing medications according to the standards of quality and guideline regulations.

Follow-up with patient, nurse, physician’s order for refill request/new prescription.

Register new patients and maintain their medication profile. Expertise in insurance billing and also handling of Medicare/Medical insurance claims.

Respond to inquiries and satisfactorily address issues, if any. Prepare and calculate dosage for pediatrics to reconstitute Meds. DOCUMENTATION AND DATA ENTRY SPECIALIST PHARMACY TECHNICIAN SAFEWAY, REDWOOD CITY, CA DECEMBER 2014 - AUGUST 2015 Promoted twice in six months due to superior performance. Answering and screening the telephone for pharmacist and other staff. Provide great customer service at pickup and drop off area. Obtain and manage the promised time given to customer for their medication. Inventory management of drugs. Filling and counting medications. Solve customer’s problem regarding medication and direct to proper representative.

Effectively present information in 1:1 or small group to customers, clients. TECHNICAL SKILLS & TRAINING EXPERIENCE:

Good handling of UV-VISIBLE Spectrometer and Dissolution apparatus. Familiar with Drug Metabolism studies, Pharmacokinetics and Pharmacodynamics.

PHARMACIST INTERN D.N MEHTA GENERAL HOSPITAL, NAVSARI APRIL 2013

Worked under supervision of Sr. Pharmacist and performed the duties efficiently, which included prescription handling, giving and measuring the medication for in-patients.

Performed the medication delivery after checking to therapeutic incompatibilities.

Great customer service and patient care.

PHARMACIST INTERN/REGULATORY ASSOCIATE GUFIC BIO

PHARMACEUTICALS, GUJARAT, INDIA FEBRUARY 2010 - JULY 2013 Contributed to research and formulation development. Assisted in various formulation techniques in production department.

Implemented the theory based knowledge of pharmaceutical sciences in quality assurance and quality control departments. Shadowing for sales departments to meet the sales target and goal within deadlines.

Solid working experience in pharmaceutical industry and academic level of - new drug discovery research.

Ensure and prompt compliance with applicability cGMP and GTP regulation company and client SOPs.

Responsible for review and approval of QC certificate,closure of batch records and deviation resorts.

Proper knowledge of filling and ensuring CAPA.

Familiar with drug and medical device development process- cGMP, GLP, IND, NDA,BLA PMA, 510k,AND clinical data and research.

VOLUNTEER WORK: SHRI SATYA SAI HOSPITAL, PUTTPARTHY, INDIA Performed 4 years of volunteer work in a nonprofit organization. Actively participated in social spiritual events of nonprofit organization. SUMMERY OF QUALIFICATIONS

Follow the knowledge and procedure of aseptic techniques and instruction of compounding products.

Expertise in computerized prescription process (input the prescription) and medication order.

Participated in audit performed by internal and external representative for FDA compliance.

Participated working with the project terms and providing research and advice on compliance with federal laws and FDA/USDA guidelines Order the routine inventory and also help for the special order for the customer.

Prepare patient’s medication profiles from physician orders. Perform as a team player with Pharmacy, Home Health, Nursing and Provider. Ability to learn and operate pharmacy computer system and other equipment. UKA TARSADIA UNIVERSITY, BARDOLI, GUJARAT, INDIA SEPTEMBER 2011- SEPTEMBER 2013

Master of Pharmaceutics (M.Pharm)

Research Project: “Chitosan-pectin polyelectrolyte complex as a carrier for colon targeted drug delivery system”

PUNE UNIVERSITY, PUNE, MAHARASHTRA, INDIA

AUGUST 2007- AUGUST 2011

Bachelors of Pharmacy (B.Pharm)

Review Project: A review on “Anti-Diabetic Drugs (Herbal Drugs)” EDUCATION

L I CENSURE CERTIFICATE OF REGULATORY AFFAIRS ON DRUGS AND MEDICAL DEVICES FROM RAPS - 2020

Follow all work procedures to ensure quality system compliance and high quality work.

Provide regulatory guidance for product development and planning throughout the product life cycle.

Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence.

Be willing to work with a lean team and wear multiple hats to create smart strategies for regulatory submission and an expanding quality management system.

Assist regulatory management in the implementation and delivery of CMC regulatory documentation.

Assist in developing regulatory strategies of new product development and resignation projects for the conducting routine regulatory operation to ensure compliance.

Good knowledge of clinical trial application, expert knowledge of FDA, ICH and global regulatory guidelines.

Producing weekly, monthly reports for both internal EY stakeholder across service lines as well as committee boards ensuring that material aspects of regulatory changes and or developments are highlighted (actual and potential). Works with regulatory affairs management to determine effective regulatory pathway for a variety of issues.

Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and internal. Assist in developing regulatory strategies and participate in a cross functional team by working closely with product development,marketing, clinical and quality functions.

Multi-lingual: Fluent in English, Gujarati, Marathi and Hindi. Highly regarded for outstanding professionalism and responsiveness. Well organized and capable of managing time efficiently. Individual contributor and effective team member in multitask environments. Able to learn new processes and operations quickly. Excellent interpersonal, communication and relationship-building skills. Technically skilled: cross-platform expertise (Win/Mac) and proficiency in Microsoft Word, PowerPoint, and Excel.

Ability to troubleshoot the issue and refer to appropriate action. Cursory knowledge for operation and care of automated equipment. Ability to read,analyse and interpret general business periodicals, professional and practical problems dealing with standard outcomes. Knowledge of IND and NDA Filing and time cycle.

Knowledge and understandings of meeting with FDA with CBER/ CDER with type A,B, and C

Proper knowledge of Application and use of on label and off label use of the product.

IND preparation, submission and maintenance with respect to market approval.

Study of non clinical part pharmacology and toxicology according to GLP guidelines; Study of drug process with its manufacturing process,analytical testing and specification.

Preparation of IND safety reports and annual reports. Good knowledge of device development process and 510 (k) filing process. Proper knowledge and guidance of device application to clinical studies, approval and maintenance of the device

STERILE PRODUCT AND ASEPTIC TECHNIQUE FOR PHARMACY TECHNICIAN

(NATIONAL IV CERTIFICATE) - MAY 2018

PHARMACY TECHNICIAN (CALIFORNIA STATE AND NATIONAL CERTIFICATE) - IN 2014 (CURRENTLY RENEWED)

CERTIFIED PHARMACY TECHNICIAN BY PHARMACY TECHNICIAN CERTIFICATION BOARD (PTCB) - FEBRUARY 2014 - CURRENT

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