NALINI BALDEO
Simpsonville,SC
Summary
Well-educated by experience at Pharmaceutical Associates Inc, in Quality Inspection, calculations, procedures, documentation, Change Control and Deviation Investigations. Well versed in a CGMP practices in a FDA regulated facility. Knowledgeable in CFR 210 & 211, and ICHQ7, Q9, Q10 Proven history of reliability, accuracy and detail shown when completing tasks over the past four (4 years) at PAI. Possess an engaging and pleasant personality with dedication to accuracy and efficiency. A driven self starter , versed in critical thinking/problem solving. Excelled at all previous positions.
Overview
2
2
years of professional experience
Work History
Document Control Support Specialist II
Paipharma
Greenville, SC
03.2022 - Current
- Perform initial Quality Assessment on all Change Controls.
- Manage the life cycle of Change Controls.
- Make Batch Production Records effective, obsolete and archive records.
- Perform initial assessment of Deviation investigations in Trackwise EQMS.
- Contributed to design and implementation of overall corporate documentation standards, numbering conventions and templates.
- Modified and maintained tools to support operations and business process creation using Adobe Acrobat, SharePoint, Excel and Access capabilities.
- Provided assistance with inbound and outbound document processes, document sorting, logging
- Maintained document control system and updated work instructions, procedures and associated databases.
- Converted documents from one application to another.
- Properly routed documents for approval via DocuSign .
- Worked with internal staff to process documents and sent for closing.
In Process Quality Coordinator 17B
Pharmaceutical Associates Inc.
Greenville, SC
09.2021 - 03.2022
- Collect Bulk samples regularly and submit to QC.
- Ensure that products are manufactured according to cGMP requirements.
- Perform walk throughs of GMP areas to ensure inspection readiness of facility is maintained; includes documentation, follow-up and escalation of observations, and areas of concern.
- Perform verifications of documents related to the manufacturing operations (cleaning procedures etc.)
- Perform in-process testing (pH, titrations, etc.)
- Inspection and Release of Manufacturing/Packaging product tanks.
- Perform TOC and Conductivity Testing on manufacturing/packaging Tanks.
- Perform QS verifications.
- Perform batch calculations ( i.e. required API for batch to be manufactured)
- Standard daily lab upkeep, ordering of pH standards and Titrants, etc.
- Function efficiently at both 201 and 1700B .
- Provided regular updates to leadership on quality consistency problems or production deficiencies.
Quality Assurance Relief Inspector
Pharmaceutical Associates Inc.
Greenville, SC
2019 - 09.2021
- Level 2 Quality Inspector with the ability to efficiently function on all production/packaging lines at 201 Delaware, 1700A , 1700B buildings and to and extent in the IPQA Lab at 201 and 1700B building.
- Inspect and promote GMP and SOP compliance in accordance with FDA regulations in both Production and Compounding Area.
- Inspect/monitor production processes and sampling of finished product.
- Identify discrepancies/defects and escalate such by consulting with Management as applicable to garner corrective actions.
- TOC testing (Total Organic Carbon) on Manufacturing tanks, Filler tanks, overhead and transfer lines .
- PH Testing and calibration of PH meter at 201 and 1700b.
- Inspection of Manufacturing tanks for release to compounding.
- Assure quality standard is met across the board.
QA Labeling Inspector
Pharmaceutical Associates, Inc
Greenville, SC
11.2018 - 2019
- Inspection and approval of labels, Inserts,Tray label and medication guide.
- Verification of all labeling material received matches physical quantity and in compliance with approved master file for each.
- Sampling plan in compliance with AQL standard.
- Perform all documentation in compliance with GMP standard.
- Scale calibration.
- Assign Expiration date for finished product in compliance with SOP and document on packaging record.
- Staging of all labeling materials required for various packaging lots.
- Use of Red prairie inventory management system to assign calculated components quantity and allocate lots(jobs) to specified lines for packaging and document said Education quantity on packaging record.
- Follow packaging and manufacturing schedule for purpose of prioritizing staging of components.
- Use of computer for various applications such as emailing, Microsoft word , Microsoft excel , power point , etc.
- Filing of Inventory cards and general office duties.
- Returns for components after reconciliation and updating of inventory.
Packaging Associate
Pharmaceutical Associates Inc.
Greenville, SC
01.2018 - 11.2018
- Labeled, recorded and inspected packaging to prepare for shipment or storage.
- Prepared orders for shipment by inserting associated paperwork, tagging boxes and scanning barcodes to upload package data to tracking system.
- Assisted with quality and production process improvements to support new packaging initiatives.
- Performed packaging tasks alongside team to demonstrate proper methods according to labor plan and assigned tasks.
Education
High School Diploma -
Caribbean Examination Council .
Guyana06.2001
Skills
- Strong attention to detail
- Results driven
- Time management
- Minimum supervision required
- Positive Factor among coworker's
- Integrity with standards for procedures
- Goes above and beyond
- Multitasking
- Precise
- Critical thinking skills
- Strategic planning
- Microsoft Excel/Word
- Knowledge of quality systems (Elnfotree, Track Wise Salesforce and DocuSign )
Timeline
Document Control Support Specialist II
Paipharma
03.2022 - Current
In Process Quality Coordinator 17B
Pharmaceutical Associates Inc.
09.2021 - 03.2022
QA Labeling Inspector
Pharmaceutical Associates, Inc
11.2018 - 2019
Packaging Associate
Pharmaceutical Associates Inc.
01.2018 - 11.2018
Quality Assurance Relief Inspector
Pharmaceutical Associates Inc.
2019 - 09.2021
High School Diploma -
Caribbean Examination Council .
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