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
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
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