Arunkumar MR
Bengaluru
Summary
- Highly skilled and detail-oriented Pharmaceutical Quality Assurance Senior Team leader with over 12.5 years of experience in Regulatory Compliance Investigation (RCI) and Corrective and Preventive Actions (CAPA). Proven track record in ensuring compliance with regulatory standards, improving quality systems, and leading cross-functional teams to achieve operational excellence.
- Skillful in handling of Quality management system through Track wise.
- Demonstrated abilities in drafting response to health authority audit observations and handling of audit management.
- Qualified Internal Auditor Plan, Conduct & close Internal audits.
- Proven skills to Handle Global policy Gap assessments and Affiliate audit observation Gap assessments.
- Familiar with Master/Executed Batch record, Standard operation procedure & study protocols creation, review and approvals.
- Familiar with DCM, D2, MCC, MES, Elixir, SAP & Track wise systems.
- Well acquainted globalized working culture.
Overview
12
12
years of professional experience
Work History
Senior Team Leader - Quality Assurance
Viatris Company (Mylan Laboratory)
06.2015 - Current
- Lead the RCI and CAPA processes to ensure timely and effective resolution of quality issues.
- Develop and implement quality assurance policies and procedures in compliance with GMP, GLP, and GCP standards.
- Conduct root cause analysis and risk assessments to identify potential quality issues and implement preventive measures.
- Coordinate with cross-functional teams to ensure compliance with regulatory requirements and internal quality standards.
- Prepare and present quality reports to senior management and regulatory bodies.
- Conduct internal audits and inspections to ensure adherence to quality standards.
- Train and mentor team members on quality assurance practices and regulatory compliance.
- Responsible for timely notification/communication of atypical events (AE) and critical quality events (CQE) to the senior leadership/management
- Responsible for data analysis and compilation to report in Monthly Dashboards, Quality Councils, Quality Business Reviews, and other Management level review meetings.
- Preparation of response to health authority audit observations and internal global audits.
Senior Executive - Quality Assurance
Mylan Laboratory Limited
02.2013 - 05.2015
- Handling of the Investigations, Change control & Market complaints through track wise application
- Handling of the Premarket supply incidents through track wise application
- Review and approval of investigations and CAPAs related production.
- Ensuring that all root cause(s) is being identified and CAPA plans are effective
- Monitoring, evaluation, identification of Gaps and communication of the findings from the Health Authority Inspections for remediation, compliance, and continuous improvement
- Also, Implementation and harmonization across sites of CAPA's in response to Health Authority observations/findings.
- Qualified Internal auditor involved in preparation of the risk matrix, Annual planer, planning of audit, conduct audit, response review approval CAPA creation and audit closure through track wise
- Supported and participated in Regulatory Agency Inspections and Third-Party Audits as subject matter expert.
- Handling and closure of the affiliate health authority audit observation gap assessment and internal global audit gap assessments of site
- Participated as scribe during Health Authority Audits.
- Executed Batch record review and release.
- Master batch record, Standard operation procedure & study protocols creation, review, approvals
- Responsible for prepare, review and approvals of SOP in D2 related to QA operations, and review of other departmental SOPs
Quality Assurance
Agila-Strides Enterprise
06.2012 - 02.2013
- As a team member of Manufacturing Quality Assurance, involved in day-to-day operations oversight from dispensing to dispatch of finished products.
- To ensure Identified deviations/ investigations in shop floor are logged in track wise, reviewed and approved according to the SOP, this includes participating with cross functional team to perform root cause analysis and to asses to the impact on the batches manufactured in suites, with effective CAPAs to prevent the recurrence
- Responsible for review and approvals of process validation, cleaning validation /verification protocols, monthly, Quarterly & Annual EMP trends
- Active participation in CFT meetings for the introduction of new products in Suites and to provide the inputs and drive the process for its execution and its successful launch
- Maintain inspection readiness and support inspections from regulatory agencies and customers, actively participate in GMP walk down to ensure line operations and facility are maintained in inspection ready state
- Provide inputs and decision making for Quality in shop floor with regard to manufacturing and its associated Deviations, Provide corrective actions as Necessary
- Responsible for the internal audit to assess the compliance to standards internal QMS including investigations, presentations of observation, remediation's and resolution of any findings
- Support risk evaluation as part of all quality activities and to ensure applicable process and product QRM are derived from appropriate risk management
Education
M-Pharmacy - Pharmaceutical Chemistry
Rajiv Gandhi University of Health Science
01.2012
B-Pharmacy -
DR HLT College of Pharmacy
01.2009
Pre-University Education -
HK Veeranna Gowda College
Maddur, Mandya01.2005
SSLC -
ST, ANN'S High School
Maddur, Mandya01.2002
Skills
- Root Cause Analysis
- CAPA Management
- Quality Management Systems
- Risk Management
- Auditing and Inspection
- Data Analysis
- Training and Development
- Investigation Management
- Change management
- Market Complaints
- Quality Systems Improvement
- Regulatory Compliance
Languages
English
Kannada
Hindi
Telugu
Awards
- Long service award, Received Long service award (10 years) from reputed pharmaceutical company Mylan Laboratories Limited.
- Academic Achievement, Secured 7th rank in M Pharmacy (pharmaceutical chemistry) Rajiv Gandhi University of health science in year -2012.
Training
- Pharmaceutical Quality System, Actively participated in 5 days training on Pharmaceutical Quality System conducted by NSF team.
- Track wise management, Participated in training on Track wise management.
Personal Information
- Date of Birth: 02/19/87
- Marital Status: Married
Timeline
Senior Team Leader - Quality Assurance
Viatris Company (Mylan Laboratory)
06.2015 - Current
Senior Executive - Quality Assurance
Mylan Laboratory Limited
02.2013 - 05.2015
Quality Assurance
Agila-Strides Enterprise
06.2012 - 02.2013
B-Pharmacy -
DR HLT College of Pharmacy
Pre-University Education -
HK Veeranna Gowda College
SSLC -
ST, ANN'S High School
M-Pharmacy - Pharmaceutical Chemistry
Rajiv Gandhi University of Health Science
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