Aparajitha K.

Experience

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  Fairleigh Dickinson University

  Jan 2013 - Jan 2015

  Student
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  Polygen Pharmaceuticals INC, Edgewood, NY

  May 2015 - Jan 2017

  QA Specialist

  • Preparation/review of Certificate of analysis• Participate in internal audits, approval of Change controls, SOPs, CAPA, etc., of the department• Keep in check the calibration status of equipment, expiry of standards and reagents, stability pulls outs, etc. in the lab and ensure that they adhere to the SOPs and GLP guidelines• Perform room releases after partial/complete cleaning and or before start of new manufacturing/packaging activity• Ensure proper labelling on all rooms and products, in the manufacturing area, staging area and warehouse.• Perform In-process checks during tablet manufacturing and packaging and sample collection for retention, analysis or AQL, wherever necessary• Issuance, review, disposition of commercial batch records• Perform visual inspection of the retention samples• Review calibration data of equipment like UV, HPLC, KF titrino, etc. anf IQ/OQ/PQ records of manufacturing equipment• Maintain stability pull out calendar and review of accelerated, intermediate and long term stability data• Preparation of APQR for approved products• Receiving and handling of customer complaints and coordinating with pharmacovigilance team• Responsible for vendor qualification and initiation vendor complaints• Sampling of raw materials, in-process materials and finished products as per the SOP• Responsible for document control• Ensure that all the personnel follow proper GMP, GDP and GLP guidelines in their line of work Show less

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  Sciegen Pharmaceuticals INC

  Jan 2017 - Feb 2022

  Senior Executive Quality Assurance

  •Review of ANDA and PAS related R&D filing documents (mostly comprising of Module 2 & Module 3 of the CTD submitted to the US FDA for ANDA and PAS filing).•Review Quality by design and Quality overall summary , i.e. Ensure robustness of product and process and smooth scale up of the batches of new ANDA products.•Conduct risk assessments, as per ICH Q9 guidelines using tools like flow charts, histograms, fish bone diagrams, etc.•Partake in Nitrosamine impurities risk assessment of all API, raw materials and finished products.•Responsible for supplier qualification of API, excipients and packaging materials. Monthly updation of the masterlists, new suppliers and facility status of the vendor. Routine monitoring of warning letters and import alerts (66-40) on the FDA Website for all the approved suppliers. •Review supplier related DMF change notifications, equivalency reports and other pertaining documentation provided, to ensure proper implementation of change at both ends. •Execute quality agreements, confidentiality agreements and supplier agreements with vendors and customers, as per the company's procedures and requirements. •Internal Audits and External Vendor Audits (onsite or remote audits).•Review, release and disposition of commercial batch records.•Compilation and review of APQR and analyze process capability (Cpk).•Recognize, analyze the root cause and resolve discrepancies in documentation and procedures.•Timely communication of discrepancy and corrective action to the management.•Partake in the Initiation, Review and tracking of Change controls, deviations, incidents and CAPA.•Use of statistical tools like Trend compilation and histograms for the analysis of incidents, deviations, market complaints, etc. for analyzing quality metrics.•Responsible for the preparation, revision and training of relevant SOPs to ensure proper GMP, GDP and GLP guidelines •Practice and enforce the QMS guidelines, US FDA guidelines and CFR regulations Show less

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  MannKind Corporation

  Feb 2022 - now

  Associate Manager

  •Assist with auditor qualification using On-the-Job-Trainings where competency in completing auditing steps/ tasks/activities is demonstrated and documented. •Participate in vendor selection in liaison with the Purchasing and Supply chain departments to assess the vendor's ability to meet defined requirements. •Support the external audit program for vendors and contract facilities that have direct or in-direct impact on a cGMP/ISO/MDSAP process including drug product, delivery system, and related packaging to ensure compliance to requirements, regulations, and standards. •Contribute to the GCP/PV audit program; auditing clinical investigators and trial sites, CROs / vendors and related entities providing Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) services to MannKind Corporation. •Maintain the Approved Vendors List and audit schedule list. •Execute Quality Agreements with vendors, service providers and contractors to define specific, agreed upon roles and responsibilities for assurance of a quality commodity or service. • Evaluate Supplier Change Notifications and Supplier Change Controls and conduct impact assessments with cross functional teams. • Assist with supplier relationships regarding non-conforming materials, deviations and CAPA as a part of the company’s SCAR program. • Supports the internal audit program that tracks compliance to internal quality systems, company procedures, and applicable regulations and standards (FDA/cGMP/ISO/MDSAP) • Quality Control (QC) review of documents for regulatory submissions. • Perform and participate in FDA readiness activities / audits. Show less