Quality Packaging Associate (GMP Compliance)
Resume:
Lakshmi Nimmala
Breinigsville, PA 18031
Cell Phone : 201-***-****
Email : *******.****@*****.***
Sharp Packaging Solutions
https://www.sharpservices.com/
January 2023 - Present
Role:Quality-Packaging associate2
Job responsibilities
Packaging requirements as defined by Standard Operating Procedures (SOP’s) and current Good Manufacturing Practices (CGMP) and GMP compliance throughout the execution of labeling and assembly.
Adherence to and enforcement of GMP compliance, performing Quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods) related to contract packaging, reviewing documentation and verifying component attributes.
Read and understand process steps within the packaging record to ensure compliance during the packaging process.
Assist where needed with the overall efficiency of the production within the assigned room or rooms.
Inspect units for quality as they are packaged.
Responsible for performing quality inspections as required per the packaging record and per AQL requirements. Inspections may include visual, functional, destructive and count checks.
Verify the accuracy, completeness and supported documentation of the packaging requirements outlined below and ensure all are supported by the appropriate documentation within the Batch Record.
Pre-start Equipment Room Check and Area clearance pages
Pre-Post Production Pages
Pre-Packaging Steps
Equipment Verification page(s)
Equipment / Component Startup Verification page(s)
Challenges
In-Process Inspections
Quality Samples
Reconciliation
Check weigher Sheets
Product/Component Transactions Waste logs
TOR Logs as Applicable
Ensure batch record documentation is accurate (lot numbers, expiration dates, item number and related data are consistent throughout the record, AQL Report is accurate), and complete
Understand process steps within the batch record to ensure compliance during the packaging process
Review batch records for any additional requests, memos, deviations, change controls, and material request transfer forms and ensure appropriate actions are taken.
Ensure room/equipment cleaning logs have been completed as applicable.
Pull all Finished Good(Reference, Retain and Reserve) and special request samples as required in batch record and material request transfer forms.
Support operations by completing line clearance verifications after room clean activities
Responsible for notifying supervision if any abnormal occurrences are observed while performing job responsibilities
SmartBug Media. (https://www.smartbugmedia.com/)
Nov 2021 - Jan 2023
Role:QA TESTING
Job responsibilities
QA Process and methodologies, Website QA,Working knowledge in website creation & content entry
QA for websites developed using Hubspot.
Functionality,content,performance,cross-browser and proper work flow.
Emails,Landing pages QA (creating and testing emails using the drag and drop builder in Hubspot)
QA for websites developed using Hubspot.
creating,reviewing test cases.
Manage and coordinate all testing and related activities.
Bharat Dynamics Limited.
(https://bdl-india.in/)
May 2008 - June 2009
Graduate Engineering Apprentice
Project #1: Security Setup and Support
Role: Developer
Bharat Dynamics Limited is using Oracle 9i and 4.5 to manage all its functional areas such as Accounts Payables, Accounts Receivables, Inventory Management and Manufacturing. The customization for handling the requirements related to security setup.
Job responsibilities
Customized the setup tables for user level security.
Design, Develop and Modify tables, forms, reports, code units, data ports using Oracle 9i and 4.5
Developed various reports according to the requirements.
Extensive use of shared, global and local variables.
Handled Technical and Functional Issues
Performed User Acceptance Testing for the changes made.
Maintaining Issue Tracker
Handled Technical and Functional Issues
Project #2: Implementation of Oracle 9i and 4.5
Role: Developer
As a developer I have been involved in the Module implementation and Payroll Generation. I have been involved in an add on Payroll.
Job responsibilities
Technical Support for the development of the Payroll
Generating Statutory reports, Pay slip and Pay Register
Customization of reports
Conducting User Acceptance Testing
Performed User Acceptance Testing for the changes made.
Maintaining Issue Tracker
Handled Technical and Functional Issues
U V Technologies Ltd.
May 2007 - May 2008
Apprentice
Experience in the Analysis, Design and Development using Oracle
Good knowledge of SQL.
Knowledge of PL\SQL programming.
Hands on experience in developing different Database applications like HRMS, Finance, payroll etc.
Working experience on different Oracle tools like Forms 4.5, Reports 4.5, Forms 9i, reports 9i.
Experience in migrating old versions of Forms and Reports into new versions.
Experience in writing Database Scripts.
Experience in developing different types of Reports Like Grouping report, Matrix report etc.
Skills
QA TESTING : QA Process and methodologies, Website QA,
Working knowledge in website creation & content
entry
PROGRAMMING LANGUAGE : C, Java, PHP, Javascript.
RDBMS : Oracle, MS-Access, PL/SQL, MySQL.
OPERATING SYSTEMS : Microsoft Windows, Linux, Mac, DOS.
TOOLS and TECHNOLOGIES : HTML, DHTML, CSS, JQuery, Rational Rose,
Photoshop, Eclipse,JDeveloper, Microsoft Visual Studio, Crystal Reports, Putty,
PSCP, Jenkins, JBoss, JUnit, SOAP UI, JIRA, Springs (novice), Java Beans
(novice), Log4j, Git, CVS, Oracle SQL Developer, Oracle Toad, Oracle SQL Plus
(novice)
Work Permit
EAD - able to work for any employer in USA
Education
Bachelors of Technology, Computer Science & Information Technology, Jawaharlal Nehru Technological University (India), 2007
Academic Project
Development Of Software For Generation Of Messages For Differential Global Positioning System.
Supported by Nalanda Telematics and Informatics Ltd (www.ntil.net).
Studied the RTCM-SC104 standard.
Designed a user interface for providing the inputs required for forming the messages.
Implemented software for connecting and communicating with a DGPS reference station and communication nodes.
Implemented CRC parity algorithm on messages.
References : Will be provided on demand
Contact this candidate