Ramya Teja Email & Phone Number

Albany, New York, United States

• Develop Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, quality standard policies and standard operating procedures, Test Protocols (Installation Qualification/Operational Qualification/Performance Qualification), and Summary Reports of critical manufacturing equipment, facilities, and utility systems.• Execution of Test Protocols (Installation Qualification/Operational Qualification/Performance Qualification), including identification and resolution of non-conformances/deviations. • Manage the projects that include the validation activities, a team working on projects that interfaces with multiple IOPS functions and locations and Prioritize projects based on business needs and available resources• Set direction for identifying and implementing projects based on understanding of the manufacturing department's needs and assess and quantify projects' impact to manufacturing, including risks and benefits.• Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures, and industry guidance.• Managed qualification projects for StatLIA, Softmax, SpectraMax, Endoscan, Unicorn Chromatography Skids, Vicell, Mass Extractor, Malvern Morphology, HIAC Particle counter, QiaSymphony, Tiamo, Ice3, Ice280, Accuseq, Morris, Biocord, etc. • Manages computer System Validation projects such as Empower, MES, Delta V (Integrations) and Lab Solution’s. • Developing change control activities for multiple equipment’s and to create various manufacturing processes and Ensure proper justification of statistical analysis and hypothesis testing.•

Chennai, Tamil Nadu, India

• Performed complete end to end validation activities for Implementing Trackwise, Process Compliance and Documentum application at client site• Written Standard Operating Procedures (SOPs) for the 5 phases of the CSV life cycle, in accordance with 21 CFR Part 11 and GMP regulation.• Provided inputs to ensure periodic maintenance of computer software/hardware that were evaluated for revalidation to follow written standards, procedure, policies, and guidelines.• Reviewed and verified test results, identified, and reported issues and provided summary test reports. • Performed Risk Assessments to verify whether the systems are Quality impacting and Part 11 compliant.• Authored User Requirements and Functional Requirements for system that include Reporting requirements of Nugenesis • Validated Nugenesis modules which include Search, Restoring and retrieving• Expertized in detail workflow of Data Acquiring functionalities• Leaded a team for validating the Systems within the allotted budget.• Involved in vendor assessment and reviewing Vendor Audit Report summarizing the SDLC approach and methodologies.• Involved in interactions with Business Owners, System Owners, Business Analyst and Technical Writers as well as QA Department.• Prepared Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases using QC.• Prepare CAPA plan, write test cases, test scripts, test summary reports for overall product, part wise assessment and improvement, report concerns if any to the suppliers.• Reviewed and prepared validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification and System Design Specification.• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.• Conducted Gap analysis and Remediation procedures according to CFR Part 11 Compliance and prepared deviation reports.