SUMMARY:

Quality Assurance professional with more than 9 years of experience in GxP regulated environment.

Review and release of the executed batch manufacturing and batch packaging records of clinical and commercial products.

Issuance, review, approve and archival of master and executed batch records and associated documents for commercial and clinical manufacturing received from different contract manufacturing organization (CMOs) and contract packaging organization (CPOs)

Review/approval of Change control, Deviation, CAPA associated with batches

Review Certificate of Analysis to ensure that all established testing criteria are met for release of batch and generate Certificate of Compliance within cGMP compliance

Performed line clearance, in process quality control tests (IPQC), Visual inspection, AQL and reconciliation of finished product

Experience with API/Drug Substance (DS), Drug Product (DP), Finished Products (FP), Document control/management (storage, archival, retrieval), GxP (cGMP/GLP/GCP/GDP) environment for clinical and commercial manufacturing

Experience of SAP, TrackWise, Master control system, Share point, LMS, MES PAS/X, Veeva Vault CDOCs, eDMS/EDC, Maximo, Microsoft office, Adobe Acrobat and DocuSign

Knowledge of FDA regulations, 21 CFR 210 & 211, ICH guidelines, 21 CFR Part 11, ISO 9001, eTMF (electronic Trail Master File), eCRF, Clinical data management

Experience working in solid (small molecule), liquid, biologics, sterile, clinical trial studies (Phase I, II & III) and commercial products manufacturing

WORK EXPERIENCE:

Alexion Pharmaceuticals, New Haven, CT 07/21 to 09/23 QA Specialist III (Remote)

Review executed batch records, related documents and batch disposition (Clinical drug product & finished product batches of small molecule & biologics) received from CMOs and support records to certify compliance with GCP (Good clinical practices), specifications and procedures

Perform batch disposition/batch rejection (quantity) in SAP system (Inventory management system) and approve all required documents electronically using DocuSign and Adobe Sign

Closely work with different CMOs regarding corrections activities and complete tasks in timely manner in fast-paced environment

Capturing and reporting metrics around quality system, Batch record review/approval turnaround time

Document management of different clinical studies (Phase I, II & III) in data management system

Provide support for review/approval of change controls, deviations, root cause analysis and corrective & preventive action (CAPAs) in TrackWise system

Quality oversight for domestic and international shipments of clinical drug products, release in SAP and provide support to supply chain and distribution as needed

Supports the quality team in the delivery of quality oversight for activities to ensure clinical products are manufactured and distributed in accordance with all regulatory and corporate requirements

Revise and update QA related SOPs in Veeva Vault system for improvement

Review and approve Label proof/variable data form, RFP (request for packaging), Packaging Specification, Pre-batch records, link reports received from different CMOs and followed GxP (cGMP/GLP/GCP/GDP) environment

Amgen Inc., Woburn, MA 11/20 to 07/21

Senior QA Associate (Hybrid)

Provided Quality oversight to ensure that operations for licensed pharmaceutical products/biologics are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations

Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations

Review and approve protocol for equipment qualification and validation in Veeva Vault system

Performed review, approval of cGMP procedures in Veeva Vault system and change controls, deviations, CAPAs in TrackWise system and Work orders in Maximo system

Review and approve executed manufacturing batch records (commercial/biologics) using MES (manufacturing execution system) Werum PAS/X system and batch released in SAP

Supports Continual Improvement initiatives, programs and projects

Support on-the-floor manufacturing activities in clean room/Aseptic environment and facilitate real time decision making regarding quality requirements and deviations

Ensure commercial manufacturing production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements

Berkshire Sterile Manufacturing, CMO, Lee, MA 02/20 to 07/20

QA Disposition Specialist (Hybrid)

Review and approve master and executed batch production/packaging records (clinical batches) to ensure in compliance with GCP

On floor QA support during manufacturing of Injectable (sterile) products like Vials, Syringes and pre-fill cartridges in aseptic environment for different clients

Coordinate with other department in batch record correction activities and data review (Raw data, deviation reports, analytical reports) of drug product and finish product to ensure QA deliverables are completed within timely manner and used Master control system as a QMS

Provide in-process and final product release in SAP based on the data review (Raw data, analytical reports and deviation reports) and compilation of all documentation for different clients

Create all documents required for release of finished product such as Certificate of Compliance, Genealogy report etc.

Provided QA metric results as required for different projects batch record review, approval and close out

Review required logbooks associated with batch records and compile necessary information for batch release such as viable and non-viable results, production reports, glove integrity results, VHP reports, terminal sterilization (Autoclave) reports and depyrogenation reports.

Sciecure Pharma, Monmouth Junction, NJ 04/19 to 08/19

QA Associate

Review Manufacturing and Packaging batch record and all associated documents of small molecule to ensure compliance with the internal specifications and cGMP manufactured by CMO

Draft/update SOPs, and review/approve specifications, deviation and CAPA

Assisted QA department in internal Audits

Monitors and trends batch record errors and provides manufacturing management with metrics

Release raw materials, finished products to ensure the testing criteria met with the specifications

Generate release documents for the finished product release

Filling, storage and retrieval of Master/Executed Batch Records and employee training records

Responsible for engaging with internal and external organizations to ensure batch release timelines are met and issues are resolved

Glatt Pharmaceutical Services, Ramsey, NJ 03/18 to 04/19

(A Division of Glatt Air Techniques)

QA Associate

Issuance and verification of the manufacturing batch records, associated forms and labels for manufacturing process of small molecules

Review manufacturing batch records, associated forms and labels and perform batch disposition

Generate Certificate of Compliance and approve Final product release

Performed line clearance by Inspecting and verifying cleaned/calibrated equipment and processing suites for manufacturing use

Inspection/sampling/labeling and release of raw materials and packaging components for manufacturing use

Receive and enter Raw materials/Packaging components into Raw Material Accountability Sheet (RMAS) data base

Coordinate and assure QA deliverables are completed and provided in a timely manner

Issuance, storage, archival and retrieval of documents

Cosmetic Essence Innovation, Holmdel, NJ 04/17 to 01/18

Quality Inspector

Performed verification of all components before starting of each batch

Provided line clearance to verify lot number, unit code, work order number and batch number

Compare and verify first article inspection of the finished product with the standard sample

Conduct in process quality tests as per customer specification

Collection and proper storage of retain sample

Perform thorough examination and reconciliation, approval and release of the finished drug product

Participate in routine visual inspections during batch filling and packaging

Ensure SOPs and cGMP guidelines are followed

(Had to wait for U.S. work authorization)

Baroque Pharmaceuticals, Gujarat, India 2010 to 2012

QA Associate (1 Year) then QA Team Leader

Daywell Pharmaceuticals, Gujarat, India 2009 to 2010

QA Associate

EDUCATION:

Bachelor of Pharmacy May 2008

Gujarat University, Gujarat, India GPA-3.6/4

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