Nitesh Upadhyay
Hyderabad
Summary
Quality Assurance expert with over 12 years in the pharmaceutical industry, dedicated to enhancing product quality and compliance. Proficient in Quality Management Systems, batch disposition, and vendor qualification. Successfully led training programs that boost team efficiency and foster a culture of continuous improvement. Experienced in navigating complex regulatory environments and implementing quality improvement initiatives. Dynamic leader with a focus on team mentorship and cross-functional collaboration. Manages Computer System Validation (CSV) and Data Integrity programmes, ensuring adherence to global regulatory standards. Facilitates effective risk management and audit preparation, consistently achieving successful inspection outcomes.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Manager, Quality Compliance
Azurity Pharmaceutical INC
Hyderabad
11.2025 - Current
- Lead and mentor a team of quality/compliance professionals to support GxP compliance activities across multiple manufacturing sites, ensuring alignment with corporate and regulatory expectations.
- Own and manage Computer System Validation (CSV) and Data Integrity programs, ensuring compliance with 21 CFR Part 11, EU Annex 11, and global regulatory standards.
- Drive validation lifecycle activities (IQ, OQ, PQ) for systems including Oracle, Veeva vault, Trackwise etc. ensuring robust qualification and documentation.
- Govern Data Integrity (DI) risk assessments, periodic reviews, and remediation plans, always ensuring inspection readiness.
- Collaborate with global quality teams, site compliance leads, and system owners to ensure harmonization with corporate quality standards.
- Plan and ensure timely execution of GxP periodic reviews and compliance monitoring activities across systems and processes.
- Prepare, review, and approve validation protocols and reports, ensuring alignment with GMP and regulatory requirements.
- Support regulatory inspections and audits (USFDA, EU) with successful outcomes and zero critical observations.
- Led the Product Quality Review (PQR) process, including preparation, review, and submission within Veeva QMS, ensuring compliance with regulatory expectations.
- Managed the end-to-end Change Control process, including initiation, review, tracking, and closure of action items to maintain process integrity and compliance.
- Facilitated and governed Quality Risk Management (QRM) meetings, ensuring effective risk identification, mitigation, and escalation to senior leadership.
- Manage implementation of quality metrics and KPI's to monitor performance.
- Collaborated with cross-functional teams to reinforce a compliance-focused culture across operations.
Assistant Manager, CQA
Intas Pharmaceutical Limited
Ahmedabad
06.2020 - 10.2025
- Auditing across INTAS facility including OSD and API facility and meticulously reviewing compliance reports from Intas manufacturing sites to confirm regulatory adherence and ensuring implementation of CAPA where necessary.
- Providing technical support to ensure compliance to CGMP and regulatory requirements.
- Preparing, reviewing, and continuously updating Corporate Quality Guidelines and SOPs related to quality systems, material control, manufacturing processes, vendor management, and validation/qualification.
- Supporting the CQA vendor management team in conducting onsite audits of vendors supplying critical materials to the Intas group, ensuring quality and compliance.
- Playing a key role in supporting site Quality and Operations teams during regulatory inspections, facilitating smooth audit preparations, and drafting comprehensive audit responses.
- Engaging in internal audits and self-inspections.
- Driving continuous improvement initiatives through implementing latest standards by reviewing Regulatory Updates, GMP Trends, 483's and WL.
- Reviewing and managing documentation processes, working closely with QA teams at third-party manufacturing sites to ensure compliance with cGMP and Quality Technical Agreements.
- Participating in rigorous audits of manufacturers supplying APIs and OSD products to Intas/Accord Healthcare.
- Provided expert technical support to Intas manufacturing sites, ensuring strict adherence to cGMP standards and regulatory requirements.
- Conducting thorough reviews of critical investigations and customer complaints.
- Evaluating the effectiveness of Corrective and Preventive Actions (CAPA).
- Implemented strategic improvements to enhance product performance and customer satisfaction.
- Leading eCSV projects of across Intas manufacturing sites by implementing QMS, DC and StackTrack software.
- Co-ordinating with OEM and ensuring latest technology at site to drive advancement in Pharma 4.0 and Industry 5.0.
- Special Achievements: Deputed to Athens (Greece - Europe) from Apr 2023 to Oct 2023 (6 month period) for quality system establishment at site in compliance to E.U.
Sr. Executive, QA
Aurobindo Pharma Limited
Hyderabad
03.2016 - 06.2020
- Review of protocol and report of Trial, Exhibit, Pre-validation & Validation batches.
- Compilation of process/product/equipment wise validation protocols, reports and summary.
- Coordinating with production & QC regarding status of validation and explaining details about validation/new product in QRM meetings.
- Performing qualification of sampling thieves.
- Drawing of samples according to process performance qualification protocol.
- Coordination in Cleaning Validation.
- Taking Swab samples for new molecule, new equipment, annual planner of equipment as well as product, Potent molecule to ensure cleaning validation.
- Submission, monitoring and updating of Hold time samples of Exhibit and Validation batches as per Hold time protocol.
- Maintaining and tracking of Hold time study as per protocol and timely submission of the sample.
- Preparation of PROCESS PERFORMANCE QUALIFICATION documents.
- Preparation of IPQA Standard Operating Procedures in DCM(Document Compliance management).
- Control of Formats, Batch documents.
- Handling of Nichelon software.
- Handling of SAP for posting the sample and tracking the data.
- Withdrawing the sample in ERP software.
- Updating the batch status in ERP Software.
- Review of cleaning validation reports.
- EXPOSURE TO SUCCESSFUL AUDIT OF: Internal audit of CQA, Indian regulatory, UK MHRA, TGA Australia, MCC South Africa, ANVISA Brazil, US FDA.
- Independently explained all the queries of auditors of my area of work with zero observation.
Officer, QA
Sun Pharmaceuticals Limited
Paonta Sahib
12.2013 - 03.2016
- Performed in-process Quality Assurance during manufacturing and packing, including line clearance, sampling, proof checking, and process monitoring in tablets and capsules, while reviewing batch manufacturing records, batch packaging records, and reconciling stage-wise yield and logging any yield deviations.
- Reported and monitored non-conformances and deviations to ensure compliance with quality standards.
- To ensure cGMP compliance at all level of manufacturing activities.
- Managed BMR and BPR entries.
- Review of BMR and BPR of Exhibit and Validation batch records.
- Execution of exhibit batches.
- Monitoring of validation, exhibit and trial batches.
- Monitoring of granulation, compression, coating and exhibit activities.
- Raising deviation, change control, incidence & non-compliance with respect to occurrence.
- Calibration of all IPQA instruments.
- To ensure the timely calibration of the Instruments on shop floor.
- Coordinated with production teams to facilitate seamless operations and communication.
- Control of IPQA documents.
Education
Masters - Chemistry, Medicinal Chemistry
VBS Purvanchal University
Jaunpur08-2013
Bachelor of Science -
VBS Purvanchal University
Jaunpur06-2011
Matriculation -
Public Inter College
Jaunpur05-2008
Matrics -
Public Inter college
Jaunpur05-2006
Skills
- Quality Assurance
- Regulatory Affairs
- Compliance Strategy
- Compliance management
- Quality System Management
- Quality control
- Auditing skill
- Change management
- Process improvement
- Risk management
- Risk evaluation
- Root Cause Analysis
- Change management
- Process improvement
- Quality metrics
- Performance tracking
- System validation
- Data integrity
- Statistical Analysis
- Information Technology
- Project coordination
- Vendor management
- Team leadership
- Communication
- Vendor management
- Project coordination
Languages
English
Hindi
Custom
Project Tracker, Intas Pharmaceutical Industry, Ahmedabad, Prepared project tracking sheets to track various electronic software implementation status across sites. Project Tracker, Azurity Pharmaceutical INC, Hyderabad, Prepared project tracking sheets to track PQR in Jeera.
Certification
- Six Sigma Certification at NPTEL (IIT Kharagpur)
- FMEA Certification at Quality Hub India
- Diploma in Computer Application
Interests
- Technology enthusiast,
- Data analysis and Visualization,
- Mentoring or Coatching,
- Reading Industry journels / Books,
- Travelling for Cultural Insights
Timeline
Manager, Quality Compliance
Azurity Pharmaceutical INC
11.2025 - Current
Assistant Manager, CQA
Intas Pharmaceutical Limited
06.2020 - 10.2025
Sr. Executive, QA
Aurobindo Pharma Limited
03.2016 - 06.2020
Officer, QA
Sun Pharmaceuticals Limited
12.2013 - 03.2016
Masters - Chemistry, Medicinal Chemistry
VBS Purvanchal University
Bachelor of Science -
VBS Purvanchal University
Matriculation -
Public Inter College
Matrics -
Public Inter college