BALACHANDAR SELVARAJ
Quality Assurance Professional
Chennai
Summary
Dedicated professional with a background in production management transitioning seamlessly into Quality Assurance within the pharmaceutical industry. Leveraging 5 years of hands-on experience in production Aseptic operations to bring a unique perspective to quality assurance processes. Demonstrated ability to ensure product integrity, regulatory compliance, and customer satisfaction through meticulous attention to detail and adherence to industry standards. Proven track record of implementing quality improvement initiatives, driving efficiency gains, and fostering a culture of continuous improvement. Excited to apply my diverse skill set and passion for quality to deliver exceptional results in the QA domain.
Overview
17
17
years of professional experience
33
33
years of post-secondary education
4
4
Certifications
2
2
Languages
Work History
Quality Assurance-Deputy Manager
Natco Pharma Limited
4 2021 - Current
- Responsible for driving the implementation of the Quality Management system, encompassing Change Control, Deviation, Incident, Planned Change, OOS, OOT, CAPA
- Lead investigations into reported non-conformances, identify root causes, and execute CAPA solutions
- Accountable for monitoring the effectiveness verification of CAPA measures
- Conduct Quality Risk assessments for Manufacturing processes and facilities
- Ensure timely completion of PQR (Product Quality Review), implementing derived recommendations
- Oversee and conclude process validation exercises by collecting and analyzing data from Validation batches
- Manage customer complaints, including investigation, response, and appropriate CAPA implementation
- Handing of return goods received from customers
- Manage recalls and conduct periodic mock recalls
- Manage Regulatory Audits, Customer Audits, supporting the closure of audit findings
- Conduct Internal Quality Audits to identify the procedural gaps and implement systems
- Drive the team in reviewing Master Batch Production & Control Record against R&D technology transfer documents
- Facilitate management reviews on Quality Metrics and follow-ups on actions/updates
- Conduct cleaning validation activities and ensure MACO calculation for setting process equipment limits
- Conduct vendor assessments, audits, periodic re-qualification, and maintain the Approved Vendor List
- Support warehouse operations and resolve associated issues
- Review and approve Equipment qualification
- Review and approve Isolator chamber & ISO-08 area qualification activities
- Perform gap analysis and implement systems and procedures to align with regulatory standards
- Respond to queries from Regulatory & Customer.
Quality Assurance-Assistant Manager
Natco Pharma Limited
04.2018 - 03.2021
- Responsible for driving the implementation of the Quality Management system, encompassing Change Control, Deviation, Incident, Planned Change, OOS, OOT, CAPA
- Lead investigations into reported non-conformances, identify root causes, and execute CAPA solutions
- Accountable for monitoring the effectiveness verification of CAPA measures
- Conduct Quality Risk assessments for Manufacturing processes and facilities
- Ensure timely completion of PQR (Product Quality Review), implementing derived recommendations
- Oversee and conclude process validation exercises by collecting and analyzing data from Validation batches
- Manage customer complaints, including investigation, response, and appropriate CAPA implementation
- Handing of return goods received from customers
- Manage recalls and conduct periodic mock recalls
- Manage Regulatory Audits, Customer Audits, supporting the closure of audit findings
- Conduct Internal Quality Audits to identify the procedural gaps and implement systems
- Drive the team in reviewing Master Batch Production & Control Record against R&D technology transfer documents
- Facilitate management reviews on Quality Metrics and follow-ups on actions/updates
- Conduct cleaning validation activities and ensure MACO calculation for setting process equipment limits
- Conduct vendor assessments, audits, periodic re-qualification, and maintain the Approved Vendor List
- Support warehouse operations and resolve associated issues
- Review and approve Equipment qualification
- Review and approve Isolator chamber & ISO-08 area qualification activities
- Perform gap analysis and implement systems and procedures to align with regulatory standards
- Respond to queries from Regulatory & Customer.
Quality Assurance-Executive
Natco Pharma Limited
04.2015 - 03.2018
- Responsible for driving the implementation of the Quality Management system, encompassing Change Control, Deviation, Incident, Planned Change, OOS, OOT, CAPA
- Lead investigations into reported non-conformances, identify root causes, and execute CAPA solutions
- Accountable for monitoring the effectiveness verification of CAPA measures
- Conduct Quality Risk assessments for Manufacturing processes and facilities
- Ensure timely completion of PQR (Product Quality Review), implementing derived recommendations
- Oversee and conclude process validation exercises by collecting and analyzing data from Validation batches
- Manage customer complaints, including investigation, response, and appropriate CAPA implementation
- Handing of return goods received from customers
- Manage recalls and conduct periodic mock recalls
- Manage Regulatory Audits, Customer Audits, supporting the closure of audit findings
- Conduct Internal Quality Audits to identify the procedural gaps and implement systems
- Drive the team in reviewing Master Batch Production & Control Record against R&D technology transfer documents
- Facilitate management reviews on Quality Metrics and follow-ups on actions/updates
- Conduct cleaning validation activities and ensure MACO calculation for setting process equipment limits
- Conduct vendor assessments, audits, periodic re-qualification, and maintain the Approved Vendor List
- Support warehouse operations and resolve associated issues
- Review and approve Equipment qualification
- Review and approve Isolator chamber & ISO-08 area qualification activities
- Perform gap analysis and implement systems and procedures to align with regulatory standards
- Respond to queries from Regulatory & Customer.
Quality Assurance-Officer
Natco Pharma Limited
08.2012 - 03.2015
- Responsible for driving the implementation of the Quality Management system, encompassing Change Control, Deviation, Incident, Planned Change, OOS, OOT, CAPA
- Lead investigations into reported non-conformances, identify root causes, and execute CAPA solutions
- Accountable for monitoring the effectiveness verification of CAPA measures
- Conduct Quality Risk assessments for Manufacturing processes and facilities
- Ensure timely completion of PQR (Product Quality Review), implementing derived recommendations
- Oversee and conclude process validation exercises by collecting and analyzing data from Validation batches
- Manage customer complaints, including investigation, response, and appropriate CAPA implementation
- Handing of return goods received from customers
- Manage recalls and conduct periodic mock recalls
- Manage Regulatory Audits, Customer Audits, supporting the closure of audit findings
- Conduct Internal Quality Audits to identify the procedural gaps and implement systems
- Drive the team in reviewing Master Batch Production & Control Record against R&D technology transfer documents
- Facilitate management reviews on Quality Metrics and follow-ups on actions/updates
- Conduct cleaning validation activities and ensure MACO calculation for setting process equipment limits
- Conduct vendor assessments, audits, periodic re-qualification, and maintain the Approved Vendor List
- Support warehouse operations and resolve associated issues
- Review and approve Equipment qualification
- Review and approve Isolator chamber & ISO-08 area qualification activities
- Perform gap analysis and implement systems and procedures to align with regulatory standards
- Respond to queries from Regulatory & Customer.
Production-Junior Executive
Orchid Chemicals and Pharmaceuticals Limited
09.2007 - 08.2012
- Involved in the aseptic manufacturing process of sterile APIs in Grade A/ISO Class 100 environment and carried out unit operations such as crystallization, ANFD unloading, Sieving & Blending activities
- Performed Non-Viable particle count in the sterile area (Class 100)
- Conducted integrity testing followed by sterilization for the sterile grade filters
- Sterilized the articles/materials in Steam Heat sterilizers and Dry Heat sterilizer (Depyrogenation)
- Sterilized the Manufacturing Equipments on campaign basis through piSCADA software
- Performed Equipment surface sanitation during the campaign after completion of every batch
- Performed the sampling, Labeling and packaging activities in-line with stability requirements
- Conducted process simulations/ Media fill studies by simulating the routine process
- Involved in Campaign/Product changeover cleaning of manufacturing equipment
- Performed rinse & swab sampling from the cleansed equipment
- Provided support for production documentation that includes handling of change control, deviations, and preparation of SOP, BPCR & investigation reports.
Education
Master of Science - Chemistry
Periyar University
Tamilnadu, India 06.2012 - 12.2024
Bachelor of Science - Chemistry
Bharathidasan University
Tamilnadu, India 06.2003 - 04.2024
Skills
Foster Collaboration
undefinedCertification
Certified in 'Investigations for the Pharmaceutical Industry' by 5Ws Consulting.
Accomplishments
- Significantly contributed USFDA Regulatory Inspections resulting in Zero 483 observations.
- Played a key role in the successful launch of a new product line (More than 10 products), including validation of manufacturing processes and coordination of regulatory submissions.
- Made significant contributions to the successful establishment of a new multi-production block, actively participating in the documentation process from inception to completion.
- Successfully managed a team through a period of organizational change, maintaining high morale and productivity levels.
Personal Information
- Date of Birth: 07/03/85
- Nationality: Indian
- Visa Status: 482 Visa Holder (Temporary Skill Shortage Visa- Medium Term)
Timeline
Quality Assurance-Assistant Manager
Natco Pharma Limited
04.2018 - 03.2021
Quality Assurance-Executive
Natco Pharma Limited
04.2015 - 03.2018
Quality Assurance-Officer
Natco Pharma Limited
08.2012 - 03.2015
Master of Science - Chemistry
Periyar University
06.2012 - 12.2024
Production-Junior Executive
Orchid Chemicals and Pharmaceuticals Limited
09.2007 - 08.2012
Bachelor of Science - Chemistry
Bharathidasan University
06.2003 - 04.2024
Quality Assurance-Deputy Manager
Natco Pharma Limited
4 2021 - Current
Certified in 'Investigations for the Pharmaceutical Industry' by 5Ws Consulting.
Holds certifications in "Root Cause Analysis and Failure Investigation," "Data Integrity and Its Compliance," "Deviation Management," and "QRM" from M/s. PharmaQA Compliance.
Accredited as an "Internal Auditor on QMS and Audit Skill" by FYMC.
Certified in “Product Quality Report” training conducted by Empiric Media.
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