Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Personal Information
Disclaimer
Timeline
Generic

SUNILKUMAR ADUPA

Hyderabad,India

Summary

Accomplished professional with over 11+ years of experience relating to Quality Assurance, Qualifications (C & Q) and Quality Management System. In depth expertise in preparing various protocols for cleaning validation, Equipment qualification-IQ, OQ, PQ (Liquids, Injections, Form Fill Seal & Vaccines) in compliance to QA regulatory requirements in manufacturing and qualification prospective. Capable to execute the effective Quality Management System & Quality Risk Management in line with ICH Q9, Q10, 21 CFR Part 312, 21 CFR Part 211, ICH E6 and ISO standards. Capable to manage and monitor the Audit and compliance activities pertaining to the Health Authorities. Capable to review of Computer System Validation (CSV) protocols and knowledge on 21 CFR. Successfully handled external audits from international agencies like MHRA, USFDA, TGA, ANVISA, CDSCO and WHO approvals for manufacturing. Aware of regulatory and guidelines requirements like, ISPE, 21 CFR Part 210, 211 & 11, GAMP-5, USFDA, EU, ASME. Successfully handled process improvement projects relating to facility, equipment and plant implementing modifications to optimize utilization of resources, minimize contamination and maintain in process quality systems.

Overview

11
11
years of professional experience
1
1
Certification

Work History

Operational Compliance Specialist

Imaging Endpoints
Hyderabad , Telangana
01.2022 - Current
  • Provide quality system management assistance within the regulations of investigational products and quality standards, specifically: 21 CFR Part 312, 21 CFR Part 211, ICH E6, and ISO standards.
    • Provide direct QA support related to Imaging Endpoints' training programs and nonconformance management (deviation program and CAPA program).
    QA responsibilities include, but are not limited to, documentation creation, editing, and/or review for procedures related to operations, QMS, etc.
    Assist in document control responsibilities for study-related documents.
    • Assist in proposal review.
    • Responsible for creating and fostering mutually beneficial intradepartmental, cross-functional and organizational relationships to drive compliance to specified program objectives.
    • Interface with Compliance and Regulatory Affairs Management to implement quality system strategies and plans, relevant to the defined role, which then facilitate continuous QMS improvement.
    • Interface with other areas of the organization to provide sound QA decision-making in operational processes.
    • Assist in responding to operational issues to prevent deviation and CAPA occurrence.
    • Assist in the management, maintenance, and reporting of IE’s CAPA and Deviation systems, including discrepancy investigation, reporting, and tracking and trending activities.
    • Assist Compliance and Regulatory Affairs Management during Study Audits, Internal Audits, Sponsor Audits,
    or Regulatory Inspections, including the effective preparation of related documentation, training of staff,
    providing accurate information and tracking of audit responses.
    • Assist Operational Compliance Management in managing Inspection Readiness Assessment and/or audit activities.
    • Evaluate the state of compliance regarding study set-up and close out activities including remediation and reconciliation of TMF documentation.
    Assist the Compliance and Regulatory Affairs Management in establishing and reporting quality metrics.
    • Ensure proper control, retention, and archival of documentation.
    Assist in implementing and maintaining QA procedures and controls to ensure the IE QMS is compliant with current industry requirements.
    • Act in a supporting role to other Compliance and Regulatory Affairs Specialist positions.

Assistant Manager- Quality Assurance

Amneal Pharmaceuticals
Hyderabad, India
08.2020 - 12.2021
  • To prepare site for external audits (Corporate/ Customer/ Regulatory)
  • To coordinate and involve in external audits/inspections
  • To prepare and review the responses/CAPA for audit findings/observations and ensuring the compliance by coordinating with cross functional departments
  • To ensure the implementation and effectiveness of CAPAs initiated
  • Daily plant monitoring to keep the facility for all time Audit readiness
  • Preparation and review of the documents pertain to supplier management
  • Preparation and review of Quality Technical Agreements
  • To make follow-up of CAPA plans from suppliers, Distributors and service providers
  • Define, implement and maintain quality system in compliance with Amneal reference quality standards
  • Define and implement a process to manage deviations, CAPAs and ERs related to GxP in a consistent manner, and train concerned people accordingly
  • Define and implement a process to manage the changes that may impact the GxP in a consistent manner and train concerned people accordingly
  • Coordinating the users & implementation leaders to close the change control, deviations and CAPA on timely manner
  • Routinely monitor the Deviation, CAPA and Change Controls for on time closure
  • Internal communication on quality issues at all levels in the organization
  • Preparation of Standard operating procedures, Record sheet templates/ forms and preparation or update Site Master File according to site changes
  • Coordinating the users to close the OOS, OOT, EM excursions and Risk assessments on timely manner
  • Handling of Market complaints: Categorization, Investigation, Risk assessment and closure
  • Deviation, CAPA & CC closure are tracked on weekly basis
  • Deviation, CAPA & CC management performance is tracked against predefined key performance indicators (KPI) and reported on monthly basis
  • Preparation of Deviation, CAPA Quarterly trends and CC annual reports as per the procedure
  • Global CAPA's assessment, evaluation and implementation tracking at site level
  • Preparation of trend data for Quality Council (QC) and Quality Review Board (QRB)
  • Responsible for imparting training to cross functional team as and when required and overall responsible for training compliance
  • Review updated guidelines and informs gaps in the current practices to respective department heads for its compliance

Senior Executive (Quality Assurance)

SANOFI HEALTHCARE
01.2018 - 07.2020

Sr. Officer (Quality Assurance)

MYLAN LABORATORIES LIMITED
Hyderabad, India
07.2016 - 12.2017

Management Staff (Quality Assurance)

CIPLA Ltd
01.2015 - 07.2016

Trainee chemist (Quality Assurance)

GLAND PHARMA LIMITED
Indore, India
06.2013 - 12.2014

Education

MASTERS OF PHARMACY - Pharmaceutical Analysis & QA

Vikas College Of Pharmaceutical Sciences - JNTU
03.2013

Skills

  • Audit & Compliance
  • QMS
  • Risk Management
  • Project Management
  • GMP, GLP & GCP
  • C & Q and Validation
  • CSV
  • VMP
  • Engineering QA
  • Documentation Review
  • Regulatory knowledge
  • Compliance Oversight
  • Investigations expertise

Accomplishments

  • Awarded with special bonus amount for handling the additional projects and supporting sponsor and regulatory audits (Dec 2022 & Jan 2024).
  • Awarded with best team player award from the QMS team & Selected for performer of the month for gap identification cross the site - AMNEAL PHARMACEUTICAL (Sep '20 - Dec '20)
  • Awarded with best team player award from the QM Steam- Cross functional category at Amneal Pharmaceuticals for the year 2020.
  • Best employee award from the QA team & Selected to attend the 4th international sterile Pharma conference held at Mumbai as delegate - CIPLA Ltd (Jan '15 - Jun '16)

Certification

  • Certified Lean Six Sigma Black Belt from IMC & CPD
  • Certified Lean Practitioner from IMC & CPD

Languages

English
Full Professional
Hindi
Full Professional

Personal Information

  • Date of Birth: 08/15/89
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married

Disclaimer

I hereby solemnly affirm that all the information mentioned by me is true to the best of my knowledge.

Timeline

Operational Compliance Specialist

Imaging Endpoints
01.2022 - Current

Assistant Manager- Quality Assurance

Amneal Pharmaceuticals
08.2020 - 12.2021

Senior Executive (Quality Assurance)

SANOFI HEALTHCARE
01.2018 - 07.2020

Sr. Officer (Quality Assurance)

MYLAN LABORATORIES LIMITED
07.2016 - 12.2017

Management Staff (Quality Assurance)

CIPLA Ltd
01.2015 - 07.2016

Trainee chemist (Quality Assurance)

GLAND PHARMA LIMITED
06.2013 - 12.2014

MASTERS OF PHARMACY - Pharmaceutical Analysis & QA

Vikas College Of Pharmaceutical Sciences - JNTU

Similar Profiles

CREATE PROFILE
SUNILKUMAR ADUPA