Quality Assurance Document Control

SUMMARY:

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

Reviewed and release/disposition of the executed batch manufacturing and batch packaging records of clinical and commercial products.

Experience working with different contract manufacturing organization (CMOs) & CRO

Review/approval of Deviations, CAPAs and Change controls associated with batches

Reviewed 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 release of materials, Supplier Qualification, line clearance, on the floor QA support, visual inspection, AQL and reconciliation of finished product

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

Experience of different QMS (quality management system) such as TrackWise, Master control system, Veeva Vault CDOCs/EDMS, SAP, MES PAS/X, Maximo, Box, Share point, LMS, Microsoft office, Adobe Acrobat and DocuSign

Experienced in internal audits, periodic review of SOPs

Knowledge of FDA regulations, 21 CFR 210 & 211, ICH guidelines, 21 CFR Part 11 and ISO 9001

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

WORK EXPERIENCE:

NJ Bio (CRO), Princeton, NJ 03/24 to Current

QA Specialist III/Senior Documentation Specialist

Quality Operational Responsibilities;

On floor support of clinical manufacturing activities (Phase I &II of Antibody Drug Conjugates (ADCs)), including area clearance, issuance, review/disposition of batch records and decision making on initiation of deviations

Review/approval of investigations, CAPAs, Change Controls and implementation of CAPAs as determined

Perform supplier qualification, risk assessment and maintain supplier qualification records up to date

Perform release of incoming raw materials, consumables and packaging materials

Master Control system/EDMS (Electronic Document Management System)/Document control Responsibilities;

Facilitate the life cycle of master documents (SOPs, Batch records, Analytical test methods, Protocols, Reports, Specifications etc.) by functioning as a document workflow coordinator with cross-functional departments

Maintain all activities to support document change control process, including supporting controlled document life cycle, document change requests and classifications in EDMS

Review, edit, formatting master documents according to approved procedures and template, maintain document properties (metadata), monitor document status, approval notifications, distributions and archiving of controlled documents

Review/approval of equipment qualification and validation protocols (IQOQ)

Work with clients for collaboration and documents approval in EDMS and train clients as needed

Perform end user training for new users, creation, modification and deactivation of users accounts according to approved procedures

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

Review/approve executed batch records, associated documents received from CMOs for clinical products

Performed lot disposition in SAP system (Inventory management system) and approve all required documents (Certificate of Compliance, Batch Genealogy report etc.) electronically using DocuSign and Adobe Sign

Closely work with different CMOs for batch production, release, unexpected events handling and corrections activities in a timely manner

Generate metrics for batch records review/approval turnaround time

Provide support for review/approval of change controls, deviations/Investigations, root cause analysis (RCA) and corrective & preventive action (CAPA) in TrackWise system to support product release

Provided support during internal audits, Revise and update QA related SOPs in Veeva Vault system (QMS) for improvement

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

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

Performed review, approval of cGMP procedures in Veeva Vault system and 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) PAS/X system and batch released in SAP

Supported in internal audits and Continuous Improvement

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

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

QA Disposition Specialist (Hybrid)

Review and approve master and executed batch production records (clinical batches) to ensure in compliance with regulatory requirements

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

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.

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

Create all documents required for release of intermediate & finished product such as Certificate of Compliance, Batch Genealogy report etc. for different clients

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

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

QA Associate

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

Update SOPs, and review/approve deviations and CAPAs

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

Generate release documents for the finished product release

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

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

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

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

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