Nital Resume - QA Batch record review 2014
- 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