Summary
Overview
Work History
Education
Skills
Familiar With Software
Audits Faced
Languages
Languages
Accomplishments
Timeline
Generic

SREE LAKSHMI KATAM

Hyderabad

Summary

Dynamic Sr. Executive in Audit and Compliance at PharmSol Europe Limited, adept at conducting Third-Party GMP Audits and driving regulatory affairs. Proven expertise in LIMS and Quality Management Systems, coupled with strong training management skills. Committed to enhancing compliance and quality standards, ensuring successful outcomes in complex projects.

Overview

10
10
years of professional experience

Work History

Sr. Executive in Audit and Compliance and RA Department

PharmSol Europe Limited.
Hyderabad
02.2023 - Current
  • Audit and compliance
  • Third-Party GMP Audits: On behalf of PharmSol Group, I performed over 10 third-party GMP audits covering non-sterile APIs, intermediates, KSMs, and finished dosage forms
  • Preparation of audit reports based on the current regulatory guidelines (ISO 9001:2015, ICH Q7, USFDA, and EudraLex Vol. 4. Part II.
  • Preparation of the audit agenda, checklist, and questionnaires for audit readiness.
  • Review of the audit report, CAPA, and closure reports as per ISO 9001:2015, ICH Q7, USFDA, and EudraLex Vol. 4 Part II.
  • Regulatory Affairs: Supported the Regulatory Affairs group as per the requirements of filings, annual updates, queries, deficiencies, and responses for China, ROW, and other European regions.

Executive (Quality Assurance)

Actavis Pharmaceutical Development Center PVT Ltd (a TEVA company)
Chennai
07.2017 - 02.2023
  • LIMS Specialist:
  • Master Data Management:
  • Handling of stability management activities, like managing stability samples in stability chambers.
  • Receive stability, method transfer, reference samples from sending sites, and load samples through as per the LIMS protocol.
  • Responsibility for loading, pulling, and receiving stability samples through LIMS software.
  • Preparation of methods, stability protocols in LIMS, and manual stability study protocol as per stability study requirements.
  • Review of relocation protocols, analytical/stability documents, and stability summary reports in LIMS software.
  • Handling of Quality Management Systems: Prepared, reviewed, and approved QMS documents for Vendor Qualification, Change Control, Deviation, Market Complaints, Risk Assessment, APQR, OOS, OOT, Return, Recall, Reprocess, and Rework.
  • Reviewed and approved change requests, held change meetings, monitored the change progress, and reviewed and approved change implementation.
  • Quality Control Laboratory Management: Handled investigations related to OOS, OOT, and performed risk assessment studies and root cause analysis.
  • Reviewed analytical method validation and verification documents; reviewed pharmacopeial updates.
  • Reviewed and released stability reports, and calibration documents related to the QC department.
  • Reviewed technology transfer documents; conducted equipment design mapping; prepared, reviewed, and approved the master validation plan, validation protocols, and reports for process validation.
  • Investigation Management: Conducted the investigation, performed root cause analysis, and reviewed and approved the investigation report for deviations, returns, recalls, and batch failures.
  • Quality Risk Management: Involved in the identification, assessment, control, communication, and review of risks related to the quality of the drug product.
  • Preparation of risk assessment reports.
  • Training Management: Conducted training sessions for staff on SOPs, GMP, and GLP requirements, as per current applicable regulatory guidelines.
  • Batch Release: Approved the batch manufacturing/packing/analytical records and verified discrepancies compliance and batch approval for sale and distribution.

Junior Executive (DQA & AQA)

SP Accure Labs Pvt Ltd.
Hyderabad
07.2015 - 06.2017
  • Handling Quality Management Systems: Preparation and review of SOPs, Master Formula Card (Both Manufacturing and Packing) and Specifications,
  • Issuance of Master Formula Card, specification, analytical test data sheets, method transfer protocols and reports, analytical method validation protocols and reports, BMRs and BPRs.

Project Trainee

Granules India Limited.
Hyderabad
12.2016 - 05.2017
  • Supported senior staff members by providing assistance as needed throughout the analysis of samples. Like physical and chemical analysis.

Education

M. Pharmacy - Pharmaceutical Analysis And Quality Assurance

JNTU Kakinada
Andhra Pradesh
04-2015

B. Pharmacy -

Hindu College of Pharmacy
Guntur, Andhra Pradesh
04.2013

Skills

  • Audit and compliance
  • Regulatory Affairs
  • LIMS specialist
  • Quality management systems (QMS)
  • Quality control laboratory (QC)
  • Investigation management
  • Quality risk management
  • Training management
  • Data integrity
  • EU GMP Annex 11
  • Quality assurance (QA)
  • Stability studies
  • Risk management tools

Familiar With Software

  • Glorya EDMS (Document Management System)
  • Studium (Training Management)
  • Labware-LIMS V5, V7, VG-LIMS and SAP (Laboratory Management System)
  • Trackwise Harmony (Quality Management System)
  • Ample logic and ICDAS (Batch Record Issuance Management System)
  • MS-Office (MS Word, MS Excel and MS PowerPoint)

Audits Faced

  • USFDA
  • MHRA
  • CDSCO
  • EU GMP
  • Customer Audits

Languages

  • English
  • Telugu
  • Tamil
  • Hindi

Languages

Telugu
First Language
English
Intermediate (B1)
B1
Hindi
Elementary (A2)
A2
Tamil
Beginner (A1)
A1

Accomplishments

  • Best performer award from 2017 to 2022 at Actavis Pharmaceutical Development Center, Chennai
  • Due to my demonstrated effectiveness and dedication, I was offered a position in the Regulatory Affairs department by the management

Timeline

Sr. Executive in Audit and Compliance and RA Department

PharmSol Europe Limited.
02.2023 - Current

Executive (Quality Assurance)

Actavis Pharmaceutical Development Center PVT Ltd (a TEVA company)
07.2017 - 02.2023

Project Trainee

Granules India Limited.
12.2016 - 05.2017

Junior Executive (DQA & AQA)

SP Accure Labs Pvt Ltd.
07.2015 - 06.2017

M. Pharmacy - Pharmaceutical Analysis And Quality Assurance

JNTU Kakinada

B. Pharmacy -

Hindu College of Pharmacy

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