Santhosh Maddela
Patancheru
Summary
Expert in Quality Assurance processes with a strong background in Bio-Pharmaceutical Industries. Proven ability to enhance quality decision-making and drive impactful results. Committed to delivering quality-driven work with a focus on thoroughness and precision. Proficient in both quality control and quality assurance methodologies.
Overview
11
11
years of professional experience
Work History
QUALITY ASSURANCE- ASSISTANT MANAGER
Curateq Biologics Pvt.Ltd
Hyderabad
11.2019 - Current
- Perform review of Drug substance and Critical Intermediate of Batch Records and COA
- Manage and close QA Backline discrepancies associated with the Analytical Batch Record Review.
- Train individuals (QA and quality control) in performing drug substance analysis in the analytical batch record review.
- Perform discrepancy assessment and evaluation (including review and closure) activities in TrackWise.
- Perform a review of OOL (EM and water), OOS associated with the batch to ensure a GMP-compliant environment.
- Perform a review of deviations and change controls in the agile track-wise system.
- Involve and improve the product quality environment as per the contamination control strategy to align with EU annex guidelines.
- Involve the APQR preparation and review.
- Assess analytical batch trend data.
- Stability data analysis and matrix monitoring
- Analyzed trends in water and EM, providing valuable insights for stakeholders.
Drafted annual summary reports to present essential information and conclusions. - Conduct review and approval of environmental monitoring data MODAEM (Lonza-application)
- Engaged in development of MODA-EM and Agile-EQMS (OOL), LIMS software
- Reviewed analytical data for accuracy and compliance in LIMS.
Approved data entries to ensure integrity within LIMS management. - Generated Certificate of Analysis to ensure compliance with quality standards.
Compiled batch release documentation for accurate record-keeping.
Prepared quality records for supplier-related changes to maintain regulatory adherence. - Execute QA Approver responsibilities for Quality Events
- SOP Management: Prepare, review, and approve SOPs, and other GMP/GDP documentation.
- Compliance: Ensure alignment with corporate and regulatory requirements, cGMP, GDP, GXP, and other applicable regulations.
- Quality Improvement: Participate in operational and quality improvement initiatives, programs, and projects.
- Stakeholder Communication: Communicate effectively with stakeholders to ensure alignment on quality objectives and compliance needs.
- Digital Tools: Expertise and strong proficiency in digital tools and computerized systems aligned with current Gxp environment
- Audit trail review of analytical equipment to identify gaps and enhance audit trails.
- Strong commitment to continuous improvement and lean practice knowledge
EXECUTIVE-QUALITY CONTROL
Indian Immunologicals Ltd.
Hyderabad
03.2018 - 10.2019
- Performed investigations for deviations/non conformances records
- Coordinated microbiological testing, release of product and testing for validation protocols
- Communicated and coordinated product activities with appropriate project teams and team members
- Performed routine and non- routine Bioburden and Endotoxin testing of equipment rinse, In-process and raw material samples
- Supported equipment qualification and validation
- Prepared periodic trend reports and analysis of microbiological data
- Prepared and maintained standards and microbial stock cultures per procedures
- Maintained GMP and GLP system and environment
EXECUTIVE-QUALITY CONTROL
Syngene International Ltd.
Bengaluru
07.2016 - 03.2018
- Perform Bacterial Endotoxin Test (BET) for Raw materials, inprocess, finished product and Packing materials
- Perform Bacterial Endotoxin Test by Endosafe Next gen PTS method
- Perform Environmental monitoring: Settle plate, air sampling, surface monitoring and personnel monitoring
- Perform Microbiological analysis of Water (Raw water, Potable water, Purified water and Water for injection
- Preparation and review of trends with respect to regulatory requirement
RESEARCH ASSOCIATE
I Zene Life Science Pvt.Ltd.
Hyderabad
08.2014 - 02.2016
- Performed isolation DNA and RNA from tissue and Blood samples
- Performed Gel-Electrophoresis,PCR,RT-PCR and centrifugation techniques
- Performed and maintain MCB and WCB cultures
- Performed culture harvest and thaw
Education
Master of Science - Biotechnology
Osmania University
Hyderabad, India07.2014
Skills
- Agile project management
- Document control systems
- Technical documentation
- GMP compliance
- Equipment handling in laboratories
- LIMS proficiency
- Quality management practices
- SOP development and adherence
- Trend monitoring
- EQMS implementation
- CSV processes and standards
- Batch record oversight
- COA documentation
- Digital tools
- Quality improvement
- Audit trail review
- Regulatory compliance
- Environmental monitoring (MODA software)
- Teamwork and stakeholder management
Accomplishments
- Technical Development: Quality Control and Quality Assurance in Microbiology Course from BITS-Biocon certification
- Department of Biotechnology certification
Professional Overview
Utilize knowledge of Quality Assurance processes to add value and make an impact in a quality decision making role. Talented technical professional with background in Bio-Pharmaceutical Industries. Results-driven and thorough with dedication to Quality-driven work. Skilled in Quality control and quality assurance.
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1
Timeline
QUALITY ASSURANCE- ASSISTANT MANAGER
Curateq Biologics Pvt.Ltd
11.2019 - Current
EXECUTIVE-QUALITY CONTROL
Indian Immunologicals Ltd.
03.2018 - 10.2019
EXECUTIVE-QUALITY CONTROL
Syngene International Ltd.
07.2016 - 03.2018
RESEARCH ASSOCIATE
I Zene Life Science Pvt.Ltd.
08.2014 - 02.2016
Master of Science - Biotechnology
Osmania University
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