Management Quality Assurance

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AISWARYA REDDY

: +91-888******* : ********.********@*****.***

Best Time to Call: Anytime (Day)

: in.linkedin.com/pub/aiswarya-katari/bb/196/564 : Aiswarya Reddy In quest of challenging role in Pharmaceutical Industry to leverage the expertise and experience gained in Documentation, Quality Assurance and Regulatory Affairs PROFESSIONAL SYNOPSIS

Extremely reliable and result driven Pharmaceutical professional with more than 3 years of pioneering experience in Documentation, Quality Assurance and Regulatory Affairs Started career as a Trainee Executive - IT Documentation and promoted to Standard Coordinator – IT with Vimta Labs Ltd

Dexterous in optimizing processes / procedures to establish robust top Quality Management Systems and in applying various quality measures to ensure Operational Excellence Own incredible enquiring mind with the capability & knowledge to plan and complete complex projects in close relationships with other members

Demonstrated success in managing various Pharmacy projects with real-time experience in planning, execution, application of methodologies, documentation and presentation of findings Experience in communicating, implementing and conducting Internal Quality Audit, Vendor Audit and GMP, Self-inspections

Potential to read and interpret test procedures, manuals, technical documents, Standard Operating Procedures (SOPs) and Food and Drug Administration (FDAs) regulations Possess excellent skills in manpower management and strong technical skills EXPERTISE

Change Management

Incident Management

Process Improvement

Quality Assurance

Strategic Planning

Eudralex 11

IT Documentation

FDA Guidelines

21 CFR part11

Regulatory Affairs

Statutory Compliance

ISO 17025:2005

EDUCATION

Bachelor in Pharmacy, Malla Reddy Institute of Pharmaceutical Sciences, India – 2012 TRAININGS ATTENDED

21CFR Part 11.

Schimadzu iforum 2014

ACHIEVEMENTS

Received best performer award for the year 2013-14 Volunteered interaction meet of NGCMA with test facility managements of GLP test facilities Received Many Appreciations from Managements and clients GLOBAL EXPOSURE

Worked with the clients from USA, Malaysia, Korea, China & Japan Page 2

WORK EXPERIENCE

Vimta Labs Ltd Jan 2013 – Present

Standard Coordinator – IT Feb 2014 – Till Date

Involved in end to end documentation and Quality control Conducting why- why and root cause analysis for the problem and rejection coming on line Maintaining documents as per 21 CFR and EU Annexure 11 standards Preparing and submitting specifications and relevant documents to regulatory authorities in a timely manner Planning management of change controls, incidents, deviations & OOX Reviewed Standard Operating Procedures (SOPs) and updated the required changes for excelling the quality performance

Conducting assessments and propose improvement methods, systems and procedures Identifying deviations, areas of non-conformance & undertaking relevant corrective actions Recording product result and product release group to insure minimal delays Reviewing the procedures, systems, documents to ensure the local & international regulatory compliance Responding to concerns from various regulatory agencies like USFDA, MHRA, USFDA, DCGI & WHO Conducting the gap assessment of cross functional departments and their resolution as per applicable regulations

Verification & implementation of CAPA proposed to external auditors or regulatory bodies Allotting numbers, issuing, investigation & closure of deviations, incidents, investigations, change control, corrective & preventive actions

Assisting quality manager in timely application to all accreditation and certification bodies and other Audits Representing Vimta during validation processes conducted by vendors Trainee Executive - IT Documentation Jan 2013 – Feb 2014 Documented and modified Standard Operating Procedures ( SOPs) to keep updated Prepared DR Drill Reports and maintain incident reports Ensured any non conformances identified are reported to Manager-IT Participated in root cause analysis and corrective actions Managed all relevant IT records and documents current (including change controls, IT requests, master lists of user Ids, email Ids, inventory of computer systems, peripherals, license software, etc.) Archived and Retrieved documents and software media Identified improvements in IT department's procedures & processes AVAILABILITY

Willing to relocate at the earliest

Possess no bond with current employer

LANGUAGES

Fluent in English

REFERENCES

Available upon request

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