PRIYESH KUMAR
Hyderabad
Summary
With a robust background in Quality Assurance, I excel in leading quality investigations and ensuring regulatory compliance. My expertise spans risk management and quality software implementation, complemented by strong leadership abilities and a knack for fostering a culture of quality. Achievements include significant contributions to inspection readiness and data integrity, underscoring my commitment to excellence in the pharmaceutical industry.
Overview
11
11
years of professional experience
Work History
Deputy Manager CQA
Hetero Labs Limited
Hyderabad
12.2024 - Current
- Responsible to oversee all the quality investigations including data integrity investigations at all the formulation manufacturing sites of Hetero Group
- Responsible for self-inspection and Data Integrity Audits of all the formulation manufacturing sites of Hetero Group
- Responsible for Gap assessment based on the audit observations and warning letters issued across the different companies and ensure compliance at manufacturing sites of Hetero Group
- Responsible for assessment and compliance of all the new published regulatory guidelines
Assistant Manager (QMS Lead)
Unichem Laboratories Limited
Ghaziabad
02.2020 - 11.2024
- Responsible for quality investigations of all QMS notifications such as deviations, market complaints, product recall, OOS and OOT (Manufacturing Investigations)
- Responsible for data integrity risk assessment, data integrity audit at site and handling of critical investigations related to data integrity and good documentation practices
- Responsible for handling the Regulatory and Customer inspections / audits at site as a primary coordinator and spokesperson from site
- Faced US-FDA inspection (Thrice), EU-GMP and multiple regulatory inspections from different countries such as Ukraine, Uganda, Kenya, South Africa, Russia, Tanzania and various ROW markets and customers as a direct auditee at site
- Presented multiple quality system documents to the inspectors and received appreciation from the US-FDA Inspector during last inspection at site
- Responsible for response writing / compliance writing and to define CAPA against the inspectional observations received at site
- Responsible for global assessment of the inspectional observations received at other sites of Unichem and assessment and compliance of the UF-FDA 483, Warning letters issued to different organizations across the industry
- Responsible for implementation and continuous monitoring of the multiple quality software at site in order to ensure data integrity and data governance through digitalization and electronic controls
- Implemented Caliber QAMS, Caliber DMS & SAP-SuccessFactors LMS software at site
- Explored implementation of eLogbook and eBMR at site through initial assessment
- Assessment / Evaluation and control of change management (Change Controls)
- Responsible for evaluation / Investigations of all Quality Management System documents at site such as Change Control, Deviation, Market Complaints, CAPA
- Responsible for handling (investigation, responding and communication) of market complaints and adverse drug events (Quality Investigations)
- Responsible for performing Product recalls and Mock Recalls from different Markets globally
- Planning, establishing, implementation and tracking of CAPA based on investigation outcome
- Control and monitoring of CAPA for its effectiveness post implementation
- Responsible for Quality Risk Management including Risk Identification, Assessment and mitigation plan
- Responsible for conducting Elemental impurities risk assessment and Nitrosamine risk assessment of drug products in compliance with current regulatory requirements
- Responsible for preparation and presentation of Quality Metrics and monthly Management Review Meetings at site in consultation with Corporate Departments
- Responsible for customer handling at site
- Also responsible for handling the requirements raised by different regulatory agencies as per current emerging requirements
- A certified trainer to provide GMP and functional trainings at site and other sites of Unichem
- A qualified auditor to perform vendor audits for RM, PM, External Laboratory / contract testing laboratories and Calibration / qualification laboratories
- Conducting self-Inspection / Internal Audits at site as per established plan
- Responsible for preparation, review and approval of Standard Operating Procedures
- Review and approval of SMF, VMP, Process Performance Qualification, Equipment, Facility and Utility Qualification
- Review and approval of Computerized System Validation including VMP, GxP Assessment, System Categorization, FRA, Validation Summary Report, System Release Certificate etc
Executive QA
Lupin Ltd.
Mandideep
11.2019 - 02.2020
- Worked as a part of site investigation team where I was responsible for handling and investigations of market complaints and deviations
Executive QA
Unichem Laboratories Limited
Ghaziabad
10.2018 - 11.2019
- Responsible for Quality Investigations of Deviation, Market Complaints, Product Recall, OOS / OOT (Manufacturing investigations)
- Responsible for change management
- Responsible for data trending and metrics preparation
- Responsible for self-inspections, audit handling and audit compliance
- Responsible for quality risk assessment, nitrosamine impurity risk assessment and elemental impurity risk assessment of drug products
- Responsible for tracking, implementation and follow-up of CAPA
Officer QA
Windlas Healthcare (P) Ltd.
Dehradun
12.2016 - 10.2018
- Worked in site investigation team (RCA Team) where I was responsible to perform investigations of Deviations, Non-Conformances, Market Complaints, Incidents, OOS and OOT (Manufacturing Investigation)
- Responsible for conducting self-inspection / internal audits at site
- Responsible for handling of regulatory and customer inspections
Junior Officer-Q.A.
Hetero Labs Limited
Baddi
07.2013 - 11.2016
- Worked as a Junior QA Officer where I was responsible for IPQA activities
- Responsible for preparation of Annual Product Quality Review
- Responsible for audit handling and compliance
- Responsible for performing cleaning validation, dirt equipment hold time and cleaned equipment hold time studies at site
Education
B. Pharmacy -
Punjab Technical University
Jalandhar06-2013
10+2 -
Punjab School Education Board
Mohali, Punjab04-2009
10th -
Punjab School Education Board
Mohali, Punjab04-2007
Skills
- Leadership Skills
- Quality Management System
- Investigations
- Trainings
- Date Integrity Investigations
- Inspection and audits handling
- Risk Management
- Quality Software
- Inspection Compliance
- Customer Handling
- Quality Culture Development
- MS Office
- Computer skills
Personal Information
- Date of Birth: 11/11/90
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
- English
- Hindi
- Punjabi
Hobbies and Interests
- Listening Music
- Sports
- Organizing events
Auditsfaced
- US-FDA, 07/18/17 to 07/22/17, 05/28/18 to 06/01/18, 03/05/19 to 03/08/19, 08/19/19 to 08/23/19, 02/07/23 to 02/13/24, Windlas Healthcare Pvt. Ltd., Dehradun, Uttarakhand, Unichem Laboratories Limited, Ghaziabad, Uttar Pradesh
- EU GMP from Finland
- WHO-India
- INVIMA-Columbia
- NDA-Uganda
- Ukraine
- Russia
- Zimbabwe
- PPB-Kenya
Activities
- Attended international symposium on 'Recent updates on mutation & cancer research at Punjab University, Chandigarh'
- Attended national conference on 'Future focus on achieving excellence in pharmacy education & research at Ganpati Group of Institution, Bilaspur'
- Attended AICTE sponsored national seminar on 'Pharma Vision 2020: Advances and Emerging trends in Pharmaceutical sciences and Research at Swift school of pharmacy, Rajpura'
Timeline
Deputy Manager CQA
Hetero Labs Limited
12.2024 - Current
Assistant Manager (QMS Lead)
Unichem Laboratories Limited
02.2020 - 11.2024
Executive QA
Lupin Ltd.
11.2019 - 02.2020
Executive QA
Unichem Laboratories Limited
10.2018 - 11.2019
Officer QA
Windlas Healthcare (P) Ltd.
12.2016 - 10.2018
Junior Officer-Q.A.
Hetero Labs Limited
07.2013 - 11.2016
B. Pharmacy -
Punjab Technical University
10+2 -
Punjab School Education Board
10th -
Punjab School Education Board
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