Sreeja Sururu

CSV Engineer with Overall 9+ years of experience (4 years in Computerized system validation and 5 years in Quality Assurance and Quality Control) with knowledge of testing, validation, and documentation in the Life Sciences domain. Skilled in preparing and reviewing validation documents, executing test protocols, ensuring regulatory compliance, and supporting quality assurance activities. Seeking a challenging position in a growth-oriented organization where I can utilize my technical, analytical, and problem-solving skills to contribute effectively while continuously enhancing my professional expertise through innovation, productivity, and flexibility.

Executive -CSV - Mylan Laboratories (A Viatris Company) - Hyderabad

(2023-07)

• Prepare and execute software validation protocols for GxP computerized systems as per approved procedures and regulatory requirements.
• Responsible for the verification, assessment, and approval of system retirement and decommissioning activities, ensuring compliance with GxP regulations and data integrity standards
• Conducting periodic reviews of GxP computerized systems and preparing corresponding compliance reports.
• Preparation of SOPs, validation protocols, and user access lists for GxP computerized systems in compliance with regulatory and quality standards
• Performing user management and security privilege configuration for computerized systems in accordance with GxP and data integrity requirements
• Preparation of inventory documentation for GxP computerized systems to support validation tracking and compliance requirements
• Change Control Management and Incident Management
• Responsible for preparation and revision of SOPs related to security setup, roles, and responsibilities for application software systems to ensure regulatory compliance and controlled access.
• Responsible for reviewing audit trails and message center logs

QA Executive - JODAS EXPOIM PVT Ltd. - Hyderabad

(2020-05 - 2023-07)

• Reviewing and approving key deliverables Supplier assessment, Validation plan, User requirement specification (URS), Functional requirement specification, Design specification and Configuration specification in compliance and conformance against with validation guideline.
• Review of High-Level risk Assessment includes GxP Assessment and GAMP categorization, criticality Assessment, ERES Applicability Assessment.
• Review and approval of all the qualification and validation protocols, plans and summary reports as per GxP, GDP, cGMP FDA Assessment
• Involving in the computer system validation, SOP Preparation, QMS activities. Change Control, Deviation, CAPA, QRM, Mitigation plan, Validation plan, URS, GAMP 5, 21 CFR Compliance
• Verification and evaluation of security management electronic records and electronic signatures as per 21 CFR Part 11 regulatory requirements
• Review of Impact Assessment, change controls, CAPA and deviations as per system policy
• Conducting self-inspections within department and other departments
• Ensure the compliance to the regulatory and internal audit observations and Quality internal audit findings and recommendations are rectified and ensure the same is implemented.
• Follow-up and tracking for the QMS elements initiated by cross functional teams
• Ensuring the effectiveness of CAPA and trending of QMS elements
• Conducting PQMR meetings as per the schedule and Preparation and updation of Site Master file and Quality Manual
• Participation in Regulatory and customer audits and visits
• Handling vendor qualifications like new vendor communications, new vendor list, vendor audits, vendor qualification report, approved vendor list, vendor annual evaluations etc.
• Review of cross functional departments procedures related to GMP activities

QC-Chemist - NAKODA CHEMICALS LIMITED

(2016-12 - 2020-03)

• Involved in Qualifications of Laboratory Analytical instruments
• Handling and Calibration of Various instruments HPLC Waters, Agilent ,.UHPLC.UV (Shimadzu) , IR(PerkinElmer),Potentiometer(Tiamo2.0), Polari meter (Jasco) , Bulk density apparatus, Melting range apparatus & UVC Chamber
• Preparation of calibration planners, preventive maintenance planners, equipment calibration charts and preventive maintenance check lists
• Performed calibration of HPLC with Empower 3 software (Make: Agilent, Waters), Working standards qualifications
• Handling of all GLP activities. & GMP Documentation and following ICH Guidelines
• Closely monitored and involved in investigations related to quality control and as well as manufacturing process

M.Pharmacy - Kakatiya University, Khammam College of Pharmacy (2018)

B. Pharmacy - Kakatiya University, Khammam College of Pharmacy (2016)

Intermediate - Bi.P.C - Board of intermediate, APRJC, Hanam Konda (2012)

SSC - Board of Secondary School Education, Vignan High School (2010)