Nital M. Rami has over 10 years of experience in quality assurance roles in the pharmaceutical industry. She is currently a Senior Quality Assurance Associate at Pharmaceutics International Incorporated, where she reviews batch records and analytical reports to ensure compliance and expedite product release or rejection. Previously, she held quality assurance roles at Shire Pharmaceuticals and served as a Quality Engineer, Quality Assurance Associate, and Process Operator. She has extensive experience with various manufacturing equipment and processes.

1. Nital M. Rami
836 Crystal Palace Court
Owings Mills, MD 21117
Home # (410) 902-7146, Cell # (443) 929-2944
nmrami@yahoo.com
Operating Skills:
• Closed Cycle Utility Spray Dryer ▪ Versifeeder
• Nice Spheronizer S-450 ▪ Solution Preparation.
• Sweco (Vibro-Energy) Separator LS-24, LS-48 ▪ PC 6/8
• Quadro comil 196-s, 194-s ▪ Bosch H&K Encapsulator
• IR-100 Moisture Analyzer ▪ Accufeeder
• Bin Blender ▪ Ohara Coating Pan
• Microsoft Office Suite
EXPERIENCE:
PHARMACEUTICS INTERNATIONAL INCORPORATED (PII) Hunt
Valley, MD
Senior Quality Assurance Associate-Batch Record Review, Release and/or Rejection (Aug.
2011- Present)
• Review and interprets Batch Record Documentation/Packaging Record
Documentation and related materials in accordance with SOPs and statutory
governing regulations in order to expedite and execute product release
● Initiates correction of errors and omissions, and assists in performing product investigations,
i.e.,
component reconciliation, as required.
• Respond to client observations relating to executed batch records reviewed.
• Assist in performing investigations involved with batch record reviews and raw materials, as
required.
• Issue “Release”, “Hold”, and/or “Rejected” Status Labels, as required and applicable.
• Initiate product “re-sampling” and finished product release “re-stickering”, as required.
• Review Quality Assurance (QA) paperwork for correctness to be incorporated in the batch
record.
• Performs “Finished Product Review” of batch records to ensure that all “Line
Clearance”, “Weighing Sheets”, Room and Equipment Labeling/Status Indicators”,
packaging components, etc., are present, signed, and dated, along with
corresponding Quality Assurance (QA) inspection paperwork.
• Ensures that any deviations, investigations, Out-of-Specifications” (OOS)
Reports, as they relate to the batch, are identified and addressed in a timely and
accurate manner.
• Review Analytical Laboratory Reports for raw materials, in-process materials, and
finished product, ensuring that all have been properly signed, verified, and
approved, as per SOPs.
• Review and disposition Raw Materials and executed batch records for “Release”,
“Hold”, and/or “Rejection” and issues Status Labels, as required.

2. PHARMACEUTICS INTERNATIONAL INCORPORATED (PII) Hunt
Valley, MD
Quality Assurance Associate- Inspector (Jan. 2010-
Aug. 2011)
• Perform “Line Clearance” and “Cleaning Verification” for manufacturing and
packaging operations per established Standard Operating Procedures (SOPs),
Batch/Packaging, and Labeling Records’ requirements.
• Perform in-process sampling, inspections, testing and batch record reviews
during manufacturing and packaging operations as per established SOPs and
Batch/Packaging and Labeling Records’ requirements.
• Perform Acceptable Quality Level (AQL) sampling and testing as required for in
process and finished product.
• Participate in the preparation for sampling, actual submission of samples to
Quality Control (QC), and disposition of samples for Cleaning Verification.
• Perform inspection of cGMP and non-cGMP areas for compliance to policies and
procedures as written approved.
• Perform daily systems verifications including, but not limited to, recording and
reporting of magnehelic gauge data and water system data and the disposition
of the systems.
• Participate in and support Annual Product Reviews (APRs).
• Submit product samples for analytical testing as required.
• Create storage systems for storage and retrieval of retain samples, as required.
• Perform investigational activities and prepare Incident Reports, Investigation
Reports, and Planned Deviation Reports, as assigned.
• Review quality systems, including policies and procedures, and recommend
improvements, affecting compliance and efficiencies.
• Engage in planning activities to provide for effective support of manufacturing
and packaging operations.
SHIRE PHARMACEUTICALS, INC. Owings
Mills, MD
Quality Engineer (11/2008 –
06/2009)
• Maintain awareness of manufacturing activities by routine direct observation.
• Provide guidance/direction on “Visual Factory” management related to quality
metrics
• Review CAPA effectiveness evaluation based on quantitative and qualitative
measurements
• Perform batch record review & release.
• Lead and participate in site quality and process improvement initiatives, and
project teams.
• Properly investigate and explain observations/non-conformances.
• Perform intermediate drug product disposition
• Represents QA on new project and improvement teams by qualifying new
suppliers, setting
• Quality/compliance requirements, developing Sop’s, approving specifications and
providing
• Provide technical transfer/validation support.
• Performed visual inspection & swabbing of TOC & HPLC equipment.

3. Quality Assurance Associate (08/2006—
11/2008)
• Perform batch record review & release in an efficient and timely manner;
including double-checking calculations to assure that are correct.
• Properly investigate and explain observations/non-conformances.
• Review and evaluate Quality Control results for raw materials, intermediates and
finished product.
• Track and evaluate any non-conformances that occur during the manufacture of
cGMP material.
• As necessary, escalate to the manager’s attention and aid in requesting a more
extensive investigation.
• Accurately calculate expiration dates of cGMP material, assuring that products
are not released for human consumption with incorrect or expired dating.
• Communicate with other departments within Shire, as well as with personnel at
contractor sites, on Quality and compliance issues. Effectively communicate
possible bath record and cGMP deficiencies to various manufacturing sites.
• Support any QA investigation involving customer complaints.
• Stay current with changes to the Code of Federal Regulations (CFR) or FDA
guidance documents.
• Create training modules and assist with the training of new QA personnel.
• Participate in internal cGMP audits & Provide backup for raw material releases.
• Knowledge of statistical methods for quality assurance, i.e. .capable of Six-Sigma
skills, Must be a highly motivated, detail-oriented individual who possesses
excellent organization and solving skills.
• Working knowledge of databases, including SAP, Access, spreadsheet
applications, Microsoft Project, Minitab and word processing to perform
necessary tasks for preparing required data analysis.
OE Batch Record Review
(08/2005 – 08/2006)
• Review manufacturing batch records.
• Assure the batch records are complete and accurate
• Ensure completion of QNs, and CAPAs, as appropriate to the record
• Perform label reconciliation
• Review and address comments to ensure completeness
• Complete and ensure Batch Record Review Forms for all observations.
Process Operator II
(04/2001 –08/2005)
• Full working knowledge of pan coating, cycle utility spray dryer including set-up,
operation and troubleshooting.
• Full working knowledge of Microsoft Office computer software.
• Full compliance with cGMP, SOP and safety standards.
• Complete and maintain a variety of documents required of a cGMP operation.
• Execute projects, tasks and follow detailed directions.
• Use knowledge of equipment in determining an effective plan to complete
assigned tasks.

4. • Full working knowledge of Fluid-Bed Processor for drying coating and drug
layering.
• Extensive solution preparation experience involving aqueous and organic solvent
for
Immediate, modified sustained and enteric release coating.
EDUCATION:
1990 – 1994 Bachelor of Arts, Anand Arts College, India
1994 Diploma in Office Computer, India
2000 Successfully completed course in Keyboard Skills, Baltimore, MD
2001 Training course in Medical Billing, Timonium, MD