Lakshmi Anusha Sanga
Quality and Business Specialist
GUNTUR
Summary
Seeking a challenging role as a Quality Professional utilizing my experience and expertise in product design, testing, GxP field , Risk Management to enhance product quality and customer satisfaction.
Experienced in performing and handling Computerized System Validations with overall 6 years of experience in software testing and validation in the field of Lifesciences and Pharmaceutical industries. Proven ability to assess software systems for Quality Assurance and Compliance with industry standards. I am skilled in creating test plans, executing tests and documenting results. Expertise and experienced in handling Quality Assurance activities in a pharmaceutical industry. Gained professional experience of 11 years.
Overview
13
13
years of professional experience
8
8
years of post-secondary education
6
6
Languages
Work History
Manager (Quality Assurance)
Quad One Technologies Pvt Ltd
04.2020 - Current
- Company Overview: (Clinion INC)
- Expertise in handling overall Validation and Documentation activities
- Gained over 11 years of sound knowledge in pharmaceutical and Clinical industry Quality Assurance & Business Specialist roles
- Leading CSV (Computerized System Validations) team
- Develop and maintain test plans, test cases and test procedures for software systems
- Analyze software requirements and Design Specifications to determine test coverage and identify potential issues
- Collaborate with development teams to ensure software systems meet quality and compliance standards
- Handling and managing External Audits
- Handling and performing Internal Audits, reporting the audit findings and drive for its successful closure and implementation of the proposed CAPAs
- Imparting trainings to the team on the new or revised procedures
- Handling and maintaining the Product related activities
- Performing Risk Assessments for all the new systems prior to its implementation
- Performing Data Protection Impact Assessments (DPIA) to ensure that the system meets the GDPR requirements
- Preparing 21 CFR Part 11 compliance assessment reports to all the systems
- Working as a Data Protection Officer to our Organization
- Analyze protocols and scope to gather design requirements
- Compile questions and design alternatives for sponsors, ensuring best practices
- Assess design risks and propose mitigation strategies, including Change in Scope
- Communicate with implementation teams to ensure adherence to standards
- Lead design discussions in internal/external meetings, ensuring compliance with business needs
- Actively seek feedback from internal and external stakeholders
- Oversee application configuration, if applicable
- Manage and facilitate review/approval of test results, SDLC, and validation documents
- (Clinion INC)
Sr. Executive- Quality Assurance
Hetero Labs Limited
08.2015 - 12.2019
- Developed and implemented Quality Systems, processes and procedures in accordance with cGMP and regulatory requirements
- Conducted Internal audits, manage corrective and preventive actions and verified effectiveness
- Conducted risk assessments, gap analysis and impact assessments of changes to quality systems and processes
- Reviewed Batch records and product specifications to ensure compliance with cGMP and regulatory requirements
- Participated in regulatory inspections like; USFDA, EDQM, COFEPRIS, PMDA, MHRA, TFDA, SAHPRA, Health Canada etc
- Provided Support to Regulatory Affairs during DMF submissions
- Trained colleagues on quality systems and processes, cGMP and regulatory requirements
Sr. Executive- Quality Assurance
Dr.Reddy’s Laboratories Ltd
02.2012 - 09.2015
- Reviewed and approved all Quality related documents
- Handled Change Requests, Incidents and CAPA’s
- Analysed Quality data to identify trends and implement corrective actions to improve overall quality and efficiency
- Conducted investigations into product complaints and other quality related incidents
- Expertise in handling track wise and SAP
- Performed Vendor Qualifications
- Prepared Annual Product Quality Review Reports
Education
M.Sc - Biotechnology
01.2009 - 01.2011
B.Sc - Microbiology
05.2006 - 04.2009
Intermediate - undefined
04.2004 - 04.2006
Higher Secondary School Leaving Certificate - Upper Secondary
04.2003 - 04.2004
Skills
cGMP
FDA regulations
regulatory requirements
project management
task prioritization
deadline management
software testing methodologies
black box testing
white box testing
regression testing
defect tracking
Azure DevOps
Software Development Life Cycle (SDLC)
Agile Methodologies
test case writing
test script writing
test plan writing
manual testing
ISO 9001
ISO 27001
GAMP5
Personal Information
- Date of Birth: 04/08/89
- Nationality: India
Phone
+91 0 8008164707, +91 0 8008164707
Timeline
Manager (Quality Assurance)
Quad One Technologies Pvt Ltd
04.2020 - Current
Sr. Executive- Quality Assurance
Hetero Labs Limited
08.2015 - 12.2019
Sr. Executive- Quality Assurance
Dr.Reddy’s Laboratories Ltd
02.2012 - 09.2015
M.Sc - Biotechnology
01.2009 - 01.2011
B.Sc - Microbiology
05.2006 - 04.2009
Intermediate - undefined
04.2004 - 04.2006
Higher Secondary School Leaving Certificate - Upper Secondary
04.2003 - 04.2004