Amirtharaj Guruvaiya
Assistant Manager
HOSUR,TN
Summary
QMS Assistant Manager with experience in Quality Management Systems, analytical quality operations, and regulatory compliance within regulated pharmaceutical environments. Skilled in leading the review and release of analytical documentation and managing Incidents, OOS, OOT, Deviations, CAPA, and instrument qualification activities. Experienced in audit trail review, document management, change control, internal audits, and data integrity oversight across analytical operations. Strong capability in cross-functional investigation, root cause analysis, compliance improvement, digitalization initiatives, and team training, ensuring robust quality decisions, effective corrective actions, and continuous inspection readiness.
Overview
3
3
Languages
7
7
years of professional experience
Work History
Assistant Manager
Maiva Lifesciences PVT LTD.
05.2025 - Current
- Lead deviation, incident, OOS/OOT, CAPA, change control, and quality risk management activities.
- Manage and maintain QMS documentation, including SOPs, policies, quality manuals, forms, records, and controlled documents.
- Review investigations and ensure root cause analysis, impact assessment, CAPA implementation, and effectiveness checks are completed within defined timelines.
- Coordinate internal audits, self-inspections, customer audits, and regulatory inspections, including preparation of responses and tracking of commitments.
- Monitor QMS metrics and prepare quality charts, periodic reports, and management review inputs.
- Ensure timely closure and effectiveness of CAPA, audit observations, deviations, and change controls.
- Support implementation of Quality Risk Management (QRM) using tools such as FMEA and risk assessment.
- Review and approve quality-related documents and ensure compliance with Good Documentation Practices (GDP) and data integrity requirements.
- Coordinate training programs, including GMP, SOP, QMS, data integrity, and quality awareness training for employees.
- Ensure proper implementation and monitoring of document control and change management systems.
- Collaborate with QA, QC, Production, Engineering, Warehouse, Regulatory Affairs, and other cross-functional teams to resolve quality issues.
- Support preparation and review of regulatory inspection responses and ensure timely implementation of corrective actions.
- Lead and mentor QMS team members, allocate responsibilities, monitor performance, and ensure timely completion of assigned activities.
- Promote a strong quality culture and compliance mindset across the organization.
- Identify opportunities for process improvement, QMS digitalization, and reduction of recurring quality issues.
Executive - Quality
Kama Ayurveda
10.2023 - 04.2025
- Supported the implementation and maintenance of the Quality Management System (QMS) in compliance with GMP and regulatory requirements.
- Supported the implementation and monitoring of Quality Policy and Quality Objectives.
- Coordinated Management Review Meetings (MRM) and prepared quality data, trends, and reports for management review.
Managed and followed up on Deviations, CAPA, Change Controls, and OOS/OOT quality events. - Supported Market Complaint investigations, including root cause identification, CAPA implementation, and effectiveness monitoring.
- Supported internal audits, self-inspections, and timely closure of audit observations.
- Maintained and controlled quality documents, SOPs, forms, and records in accordance with document control requirements.
- Supported quality risk assessments and investigations to identify root causes and prevent recurrence of quality issues.
- Coordinated with Cross-Functional Teams (CFTs) for the timely resolution of quality-related issues.
- Prepared quality metrics, trend reports, and periodic quality reports for management review.
- Supported GMP training and quality awareness activities for employees.
Analytical QA-Senior Executive
Cipla Ltd.
11.2021 - 10.2023
- Reviewed [150 -200] analytical documents and release records weekly to support timely QA decisions and compliance checks.
- Completed [10 -15 ]% of assigned deviation and change control actions per month through structured investigation and follow-up.
- Having good knowledge in review and release of analytical documents as well as handling of software and instruments review.
- Handling the investigation and root cause identification for Non-conformance as OOS, OOT, OOAC, OOAL, Incidence, Deviation etc.
- As a implementer user in document management, handling of CR activities like CR evaluation, approval activities.
- Carrying out monthly and quarterly review of software audit trails, user management controls and privileges.
- Implementing new ideas in the area of documentation and digitalization of work.
- Conduct the internal audits and test method assessments.
- Review and approval of method validation, method transfer protocols and reports.
- Develop and implement quality assurance policies and procedures to ensure compliance with regulatory requirements and industry standards.
- Conduct internal audits and oversee audit responses to regulatory bodies.
- Collaborate cross-functionally with manufacturing, research and development, and regulatory affairs teams to resolve quality issues and improve processes.
- Provide guidance and training to junior QA staff on quality systems and regulatory compliance.
- Support regulatory inspections and assist in the preparation of regulatory submissions.
- Stay current with industry trends and regulatory changes, ensuring that the company remains in compliance with all applicable regulations
QC-Junior Executive
Accord Life Spec. Ltd.
09.2020 - 11.2021
- Possess hands on experience in handling various analytical instruments and equipment. Having adept knowledge on GMP, GLP requirements with respect to analytical domain.
- Sampling and Analyzing of Raw Materials samples (API, Excipients and Hard Gelatin Capsule) and Packing Material samples (Carton, Aluminium foil, HDPE Container, PVC/PVDC etc.,)
- Wet analysis of In-process materials, finished Product and stability samples Sampling and analysis of water
Trainee- QC
Res-tech Pharma
05.2019 - 09.2020
- Sampling and Analysis of water, RM,PM,FP & IP Materials
Education
M.Sc. - Biotechnology
Ayya Nadar Janaki Ammal College
05-2019
B.Sc. - Biotechnology
Ayya Nadar Janaki Ammal College
05-2017
Skills
LIMS
Trackwise
Document control
Change control
Deviation investigation
21 CFR Part 11
ALCOA principles
CAPA
MS Office
Chromeleon 72
Lab Solution
ICDAS
Audit trail review
SOP writing
Trend report
DECLARATION
I hereby declare that all the above details are true to the best of my knowledge.
AWARDS
Awarded as best documentation RFT, CIPLA 2023-02-01, Got Spot recognition in the categories of purpose inspired and responsibility centered, CIPLA 2022-11-24, Awarded as best documentation RFT, CIPLA 2022-06-24
Timeline
Assistant Manager
Maiva Lifesciences PVT LTD.
05.2025 - Current
Executive - Quality
Kama Ayurveda
10.2023 - 04.2025
Analytical QA-Senior Executive
Cipla Ltd.
11.2021 - 10.2023
QC-Junior Executive
Accord Life Spec. Ltd.
09.2020 - 11.2021
Trainee- QC
Res-tech Pharma
05.2019 - 09.2020
B.Sc. - Biotechnology
Ayya Nadar Janaki Ammal College
M.Sc. - Biotechnology
Ayya Nadar Janaki Ammal College