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Click here or scroll down to respond to this candidateCandidate's Name
Email: EMAIL AVAILABLE Mobile: PHONE NUMBER AVAILABLEPROFESSIONAL SUMMARY:As a Quality Engineer With over 5+ years of experience, I specialize in quality assurance (QA) within pharmaceutical and healthcare domains. Adhering to GAMP 5 and FDA/EU regulations, I ensure robust Computer System Validation (CSV), Commissioning, and Qualification Validation processes. Proficient in V Model, Waterfall, and Agile methodologies, I excel in handling ERP validations, QMS, LIMS, SAP, Trackwise, Veeva Vault, QT-9, Master Control, and LMS. Document review, SOP creation, and compliance management are integral to my practice. I support audits, reviewing Batch records, COAs, and Stability Operations ensuring adherence to GxP guidelines, and handling deviations, CAPA, and Change controls adeptly. My expertise in risk assessments bolsters project outcomes while maintaining regulatory compliance. Additionally, I develop comprehensive Quality Management Plans (QMP) and implement QA best practices to optimize processes. Committed to continuous improvement, I drive excellence in QA and validation practices. WORK EXPERIENCE:Quality Assurance Specialist, Pisgah Labs. Inc, Pisgah Forest, North Carolina Jan 03, 2024 Present Designed, implemented, and managed stability study protocols to ensure compliance with regulatory requirements and internal standards. Led validation projects, including Process Validations, CSV, and CQV ensuring adherence to regulatory guidelines(such as FDA, EMA). Developed validation master plans, protocols, and reports for various equipment, processes, and systems to guarantee product quality and data integrity. Implemented training programs to ensure SOPs were effectively communicated and followed by relevant personnel. Implemented robust change control processes to assess, approve, and document changes to procedures, equipment, and systems, minimizing risks to product quality and regulatory compliance. Conducted thorough risk assessments utilizing tools such as FMEA (Failure Mode and Effects Analysis) to identify and mitigate potential risks to product quality and patient safety. Managed the CAPA process, including investigation, root cause analysis, and implementation of corrective and preventive actions to address deviations, non-conformances, and quality issues. Investigated and documented deviations from established procedures, collaborating cross-functionally to determine root causes and implement corrective actions to prevent recurrence. Ensured timely closure of deviations while maintaining compliance with regulatory requirements and internal quality standards. Participated in regulatory inspections and audits, providing documentation and support to demonstrate adherence to quality systems and procedures.Quality Engineer, Precisesoft, Inc, Texas United States Jan 17th, 2023 Aug 15th, 2023 I have worked as an Intern in Precisesoft, Inc. in a Quality Engineer role for 0.6 Months. I have worked in the Role of quality contact and Subject Matter Expert (SME) for Computer System Validation, Risk Management, and Quality Management Systems. Prepare and review Validation protocols like Project Validation plans, & and other major system documentation in both Quality and Production environments to ensure compliance and data Integrity for a computerized system. Involved in internal audits of SDLC, IT infrastructure, and SOP compliance. Documented evidence that the Computerized Systems are designed, implemented, and maintained as intended. Appropriate Procedures are deployed for System Maintenance and Governance from system inception till retirement. Creation of Migration/Retirement plans and Periodic review of the systems. Documentation and Report creation.Sr. Validation Analyst, IVY works, India (Full time) Sep 2017 Dec 2021 I have worked as a Senior Validation Analyst for 4.3 years and completed end-to-end implementation projects. I have worked with major clients in India like LUPIN Limited, STRIDES Pharmaceuticals, Alkem Laboratories, Zydus Cadila, and Symbiotech Indore. Performed Computer System Validation, Audit Support (IT), and GXP (GMP, GCP, GLP, GDP) analysis by Using GAMP5 and V Model for ERP applications. Good exposure to Information Technology and Project Management with sound knowledge of various project implementation methodologies. Involved in the implementation of various developments concerning Modules of GXP software like SAP, DBMS, LIMS, and Trackwise. Good with unit testing & and scenario-based testing along with technical specification document preparation. Profound debugging skills, error resolving, & and updating discrepancy logs. Wall of Fame for my contributions towards the project in the year 2020-2021. Reviewing, Developing, and maintaining GAMP lifecycle documentation. Completing 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems, including remediation and validation of deficient systems. Prepare, review, and approve Project Validation plans, & and other major system documentation to ensure consistency with CSV Policy & and system life cycle SOP. Create Software Validation Life cycle documents. (GxP assessment, User Requirement Specification, Functional Specification, Risk assessment, Validation Plan, Test Plan, Test Protocol, Validation report, and System acceptance). Support the development and give training to internal modules SOPs. Validation coordinator for global/site IT validation projects Writing, Review& Update Periodic review report, and document review that occurs periodically to evaluate whether a computer system remains in a Validation state. Review of Software Life cycle documents. Preparation and Review of IQ/OQ/PQ Protocols and Test Cases. Review of operational discrepancies initiated after system validation. Review of change controls relevant to new system implementations and operational changes. EDUCATION: Masters in management information systems, Northern Illinois University, Illinois, USA. GPA: 3.4/4 May 2023 Bachelor of Engineering in CS, Andhra University, India GPA: 7.28/10 May 2017 |
