NAGARJUNA SAI SANDEEP ALLURI

To obtain a recognizable position in an organization, where there is an ample scope of growth as an individual/ team that gives me a chance to enhance my skill sets and gives my best to the organization.

Professional offering 7 years 4 Months of experience in Project Execution, Installation, Testing, Commissioning, Maintenance of Automation, Instrumentation and Quality Assurance Coordination skills along with the ability to support multiple and simultaneous projects. Having working experience on green field project to build a new fully automation (DCS) API facility at Visakhapatnam. Active participation in audits and assisting the auditor during plant rounds and ensuring of compliance. Proficient in managing site operations and in execution of engineering & IT projects including installation/commissioning of equipment and integration of various systems/ application. Hands of experience in validating software's, equipment's and PLC, HMI, SCADA system's as per GAMP 5 and 21 CFR 11 guidelines. Handling and evaluation of Change Controls, Deviations, Incidents, CAPA & market complaints. Tracking of Change controls, its implementation and ensuring the effectiveness periodically. Dynamic leader with strong communication and problem-solving skills; possess analytical mind with the capability to think clearly as well as logically.

• Certificate of Pharma Process Technology (CPPT), CBIT College, Hyderabad
• Diploma in Pharmaceuticals- Tata Institute of Science and Technology (TISS).

• Technical specialist in creation of new fully automation API facility at Visakhapatnam.
• Contributed and accompanied customer audits and 5 regulatory audits (USFDA, EUGMP, and CDSCO) in Past 7 years.
• Key member in implementation of L2 integration of equipment and its interface with MES.
• Handling computerized system qualifications / validations (Equipment's, IPC, DCS, HMI, SCADA, and PLC).
• Supported in the DCS qualification and its stabilization.
• Coordinating and facilitating activities between Integration team [Delta-V] and RA team for smooth execution & implementation of e-BMR system.

• To ensure GMP/GEP/GAMP guideline requirements compliance in Pharmaceutical manufacturing. Implementation of digitalization in all production activities.
• Release the order for execution and Explode and Release the cleaning order for execution.
• The basic layout of the execution window of the production execution client
• Review of Installation, validation, maintenance & troubleshooting of MES software, servers, and systems related documents.
• Exceptions Review and Acknowledgement and Aborting and Reactivating Unit Procedures.
• Identify GxP gap analysis of IT systems and implementing necessary corrective action.
• Responsible for the integration of any third-party systems with MES from quality side.
• Anchoring disaster management and business continuity plan in MES.
• Monitoring MES communication with SAP systems troubleshooting communication issues or SAP posting issues and resolving without business impact.
• Developing and training of personnel to the EBMR activities and Recipe Authoring.
• Credible for initiating several concurrent projects for different applications, responsible for coordination, timely development, production functioning and smooth implementation of automation systems.
• Ensuring highest standard of customer satisfaction and quality service; implemented procedures to improve customer satisfaction level and resolved customer queries.
• Participation in the investigation for deviations / customer complaints / intermediate failures, if it involves equipment/system performance issues and review of deviation investigation reports along with ensuring the implementation of appropriate corrective actions.
• Review of User Requirement Specification (URS) and Design Specification (DQ) documents.
• Review of all the master qualification (URS, DQ, IQ, OQ, PQ, and RQ) protocols, general protocols.
• To perform Computer System Validation based on 21 CFR part 11 compliance requirements.
• To perform risk-based assessments/ approach to compliant GxP computerized systems.
• Review of data backup (Auto/Manual), data restoration and data archival activity as per schedule.
• Review of GXP, Non GXP tickets, user management records periodically.

• Father's Name: Venkata Sesha Rao
• Date of Birth: 12/12/94
• Nationality: Indian
• Marital Status: Single

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