SUMMARY:

• Professional with over 7 years of QA/RA/QC experience in the pharmaceutical industry with more than 2 years of regulatory affairs and quality assurance experience in the pharmaceutical industry.
• Working knowledge of creating and reviewing Change Control Events, IMP Events, tracking of deviations, CAPAs, and OOS events.
• Extensive knowledge of on - site's manufacturing processes and procedures. Proficient in reviewing deviations, CMC change controls, work orders, protocols, reports, batch records, and other GMP documents.
• Working knowledge of SAP application in releasing materials and batches throughout the manufacturing process, creating and maintaining BOM, releasing BOM for usage, maintaining vendor data using SAP application.
• Experienced in writing different SOP’s, stability protocols, batch record maintenance, BPR, BMR, APQR along with investigational CAPA commitments.
• Having responsibility for plant quality systems. Problem solver and detail oriented. Excellent interpersonal and communicational skills. Results-driven, a skilled leader focused on achieving success and increased productivity through improvement in operations, quality, and safety.
• Have knowledge of ICH Guidelines, 21CFR. Working with ISO7/8 environment, FDA regulations along with following Strong OSHA regulations for General Industry (OSHA 500).
• Analytical chemist with more than 4 years of experience in research and development, involved in AR&D activities of generic drug products with outstanding skills in method validation/verification, method transfer, Instrument Validation (IQ, OQ and PQ-SIP, CIP, EM), and documentation for FDA approval along with strong experience in GMP compliant environment mainly in QA and packaging.

PROFESSIONAL EXPERIENCE:

Quality Specialist

Confidential - Boulder, CO

Responsibilities:

• Review and approve GxP laboratory test records, including specifications.
• Respond to all data reviews on a timely basis by reviewing and approving stability protocols and stability data at respective timepoints for compliance, trends, and out-of-specifications.
• Monitor and audit all potential sources of safety information including (but not limited to) recorded calls, text messages and other records for the presence of Adverse Events and/or Product Quality Complaints. Ensure all safety data found is captured, recorded, and reported per company SOPs.
• Review written Adverse Events and/or Product Quality Complaint reports submitted & ensure they are detailed, accurate and complete and meet company’s requirements and standards.
• Documenting Quality Agreements. Responsible for leading Internal, Supplier and Client audits. Support management in responding to audit findings on a timely basis.
• Performing daily, weekly, and monthly reconciliations of adverse event as per agreements.
• Handling Market Complaint, preparing report on aggregate data and provides recommendation for further escalation.
• Organizing and maintaining submission components associated with a regulatory submission electronically.
• Assisted management with the development of new and revised SOPs executes validation & qualification studies, performs investigations and other assignments as required.
• Handles Change Controls, Deviations, Corrective Actions, and Preventative Actions (CAPA) through effective quality management tools. Review and approve documents in an electronic document management system
• Monitors and ensures that batch records are audited per manufacturing /packaging /shipping requirements when required.
• Manage/Enforce laboratory GMP systems and ensure that they are adequate, sustainable and are being followed. Research and propose capital projects for the laboratory.

Regulatory Associate

Confidential

Responsibilities:

• Responsible to conduct weekly one-point lessons to operation, facilitating and conducting training, and CAPA review board meetings along with follow up actions.
• Conducts annual cGMP training on routine basis and as per the company policy. Preparing and Reviewing documents and its results in terms of product stability and making stability Protocol, along with annual product report preparation.
• Supporting all submissions and projects, ensuring tasks are completed within the expected timeline and standards.
• Coordinating and reviewing with external vendors for project support activities including Residual solvent statements, TSE/BSE statements, Melamine free certificates, cGMP certificates, debarment certificates, US agent letters, DMF LOAs, technical data sheets and drawings.
• Following up with purchase team for DMFs and necessary information required from the manufacturer for the filling.
• Reviewing change control, work order, stability protocols, validation protocols, SOP’s and investigating deviations. Reviewing QC data and preparing CoAs.
• Responsible for the execution and maintenance of the APQR. Operating manufacturing process by maintaining BMR, BPR.
• Schedules and coordinates management review and quality data review meetings, including summaries of the data presented, conclusions, and meeting minutes as required.
• Conducts annual cGMP training on routine basis and as per the company policy. Preparing and Reviewing documents and its results in terms of product stability and making stability Protocol, along with annual product report preparation.

QA&RA Associate

Confidential

Responsibilities:

• Preparing regulatory submissions such as Annual reports, ANDA, NDA/BLA and Annual product review.
• Reviewing test procedures and specifications in accordance with FDA.
• Reviewing Manufacturers & outside testing lab information required for ANDA filling
• Reviewing stability compilation and executed batch records.
• Providing Regulatory compliance support in the development, revision, review, and approval of labeling content for regulatory submission, as well as any post marketing labeling changes.
• Liaising with Regulatory Affairs members and other cross-functional teams (e.g., supply chain, legal, medical, pharmacovigilance) to ensure the accuracy of all information included on the label.
• Providing the RA compliance approval on labeling review process steps and coordinate with other Regulatory functions during the submission, approval, and notification of new/revised labeling content.
• Assists in compiling and completing high quality ANDAs and Amendments ensuring final submission meets the requirements of ANDA checklist recommended by US FDA.
• Documenting SOP’s and recommending SOP revisions for the quality operations and other departments.
• Prepare SOPs, STPs, method development reports, method validation protocols, laboratory notebooks, complete all related analytical reports, write summaries, keep proper documentation in compliance with SOPs and prepare COAs for the quality control sample.
• Responsible for QA compliance processes, including coordination of day-to-day activity, maintenance of associated documentation, participation of process enhancement and training new users.
• Support in FDA inspections to provide required documents and tracking of the FDA inspection documents.
• Preparing and tracking of stability protocols and compilations required for ANDA filling.
• Charging and pulling the stability samples at regular intervals for testing as per the stability protocols.
• Reviewing, tracking, and closing of deviations, Investigations and CMC change controls.
• Reviewing and tracking of work orders and batch records, protocols, and reports.
• Reviewing documentation including batch logs, training records, shipments etc. for accuracy, completeness, and adherence to cGMP’s.
• Responsible for review of IQ, OQ, PQ and DQ documents of new equipment’s.
• Issuance and managing the Laboratory Notebooks. Reporting and presenting reports and preparing product license documentation such as Protocol, Testing Method, Certificate of Analysis, summary report.
• Review of Vendor Qualification and reduced testing (Skip testing) reports.
• Proficient in using Microsoft Office Suite, Adobe Acrobat, SAP software.

AR&D Scientist

Confidential

Responsibilities:

• Experience in analytical testing of test samples/materials as per USP monograph, In- House or other compendia monographs (full monograph testing) to assess its identity, purity and strength.
• Performs assay, related substance, residual solvents, blend uniformity, content uniformity, dissolution, water determination of stability and in process samples, raw materials and method validation, drug release study using dissolution. Having a depth knowledge in chromatographic analysis such as tailing factor, plate count, USP resolution, peak purity etc., of chromatographic peak.
• Ensuring all testing is carried out in accordance to approved methods, and in compliance with cGMP and cGLP.
• Independently plan and make adequate inventory of test reagents and solutions, assure supplies are ordered as needed to perform assigned work. Ability to train other personnel in analytical instrumentation and auditing the analytical work.
• Perform instrument calibration and maintenance as needed and perform long and short-term research studies including method development and modifications.
• Performs daily routine chemical analysis on in-process, finished product, stability, and raw material samples. The scientist is expected to have basic knowledge of developing stability indicating HPLC and GC methods and execute method validation.
• Have good instrumentation skills, including HPLC, UV-Vis, and USP dissolution apparatus 1, 2. knowledge and understanding of dissolution apparatus 3, 4 and7. Basic knowledge of TGA and DSC, other physical characterization techniques. Good at enter data accurately and to handle multiple tasks well.
• Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders.
• Coordinates acquisition, installation, and maintenance of primary and secondary reference standards used in the laboratory. Inspects safety showers, eye wash stations and fire extinguishers used in the laboratory.
• Performs methods verification and method transfer of validated analytical procedures as required.

Intern

Confidential

Responsibilities:

• Have good understanding on HPLC method development, method validation and have performed analysis of various drug products and substances. Have knowledge in handling of Empower, chromatography software in setting up the method and processing the results.
• Maintain awareness of regulatory and cGMP requirements related to company’s policy. Operate, maintain, and troubleshoot analytical instruments.
• Conducts daily calibrations of analytical balances and pH meters. Maintains everyday lab records and follows SOPs for the operation of instruments and performing experiments. Reviewed and drafted SOPs and user manuals for the equipment's and ISO requirements for process equipment to ensure they meet FDA requirements.
• Prepares mobile phase and samples for HPLC, molar solvents for quantitative and qualitative analysis. Performs dissolution and disintegration tests and helps team in method development and Method validation.
• Learned maintenance of analyzed data in QA (Quality Assurance) Department.