Summary
Overview
Work History
Education
Skills
Accomplishments
Personal Information
Timeline
Generic

SHAKIR GALEBSA

Hyderabad

Summary

Dynamic Sr. Manager with extensive experience adept at leading teams and ensuring compliance with GMP regulations. Proven track record in risk mitigation and effective review skills, successfully implementing CAPA plans and validation activities. Skilled in Computer System Validation, fostering a culture of quality and continuous improvement.

Overview

17
17
years of professional experience

Work History

Sr. Manager

Biologicale E Ltd.
Hyderabad
04.2024 - Current
  • Planning, execution, review, and approval Site Qualification and Validation activities, ensuring compliance with regulations.
  • Conducted GAP analyses for Computerized Systems at the site and developed effective CAPA plans to mitigate any identified gaps.
  • Developed and implemented SOPs, conducted training, and performed GAP analyses to ensure compliance with regulatory requirements.
  • Computer System Validation (CSV), Software Validation (DCS/SCADA/PLC/Standalone computers) and Excel sheet validation activities in accordance with 21 CFR, GAMP5, and EU Annex 11 requirements.
  • Coordinated with Engineering and supported the team for all QMS activities related to engineering, including initiation, implementation, investigation, review, and closure.
  • Investigations- Prepared, reviewed, and approved scientific rationales defining effective CAPA plans and followed up to ensure their implementation and effectiveness.
  • Guidance, execution and monitoring the Qualification and Validation activities (Execution and documentation) which includes URS, RA, TM, DQ, IQ, OQ and PQ and complying to the National and International regulations as applicable with rationale and logical thinking.
  • Periodic monitoring of Equipment performance as part of Life cycle management of equipment.
  • Led a team of 20 Quality professionals, for Qualification and validation, compliance and engineering assurance.

Manager

CuraTeQ Biologics PVT LTD.
Hyderabad
08.2016 - 04.2024
  • Prepared Validation deliverables and executed.
  • Collaborated with clients to develop and implement User Requirements Specifications and Change Control in Project Planning stage.
  • Performed Risk assessment for GXP computerized systems at site.
  • Hands on experience in preparation of 21 CFR Part 11 assessment and compliance Report.
  • Implementation of the CSV activities, qualifications within the timelines. Maintain computerized systems in accordance with 21 CFR part 11 compliance.
  • Created detailed IQ & OQ test cases for use on diverse projects.
  • Performed gap analysis procedures and detailed reviews to optimize project deliverables.
  • Support resolution of CSV deviations/errors and provide compliance oversight to software validation projects.
  • Perform project management activities for CSV process of an overall system project.
  • Scheduling support and review of audit trails for computerized systems.
  • Coordinates with all stakeholders and completes the CSV projects.
  • Involved in clean room validations, Water System, AHU validations and equipment validations.
  • Facility qualifications and area qualifications protocol preparations and execution.
  • Installation and qualification of process equipment’s Bio Reactors, WFI coolers, centrifuge, autoclaves, TFF systems, CIP/SIP systems and -80 Deep freezers.
  • Installation and maintenance of Building Maintenance System, Door Interlocking System, Remote Alarm Monitoring System and Access Control System.
  • Hands on experience on Qualification and validation of utility systems (Waters Systems, PSG, WFI Systems, HVAC) and Qualifications of process equipments (Bio reactors, Fermentors, Vessels, WFI coolers autoclaves, TFF systems, filling machines, vial washing machines, lyopholizer and -80 Deep freezers.)
  • Handling of QMS elements such as Change controls, Deviations, and implementation of CAPA.
  • Involved in regulatory audits (EMA), consultant audits and customer audits and engineering audit compliance.
  • Handling digitalization projects such as training management systems, document management systems and enterprise management system.
  • Develop plans, qualification test protocols, traceability matrices, reports, IQ/OQ protocols and all documents and deliverables with the scope of the digitalization projects.
  • Installation and commissioning of Building Maintenance System, Door Interlocking System, Remote Alarm Monitoring System and Access Control System.

Assistant Manager

Mylan Laboratories Ltd (Unit-8)
Vizianagaram
06.2015 - 08.2016
  • Calibration and Maintenance of Instrumentation.
  • Directed, guided and Reviewed project deliverables for Solvent Dispensing System, Solvent Recovery System, Reactor Utility Automation.
  • Performed Risk assessment for GXP computerized systems at site.
  • Preparation of validation protocols as per GAMP5 categories.
  • Generate a CSV validation plan detailing the scope of work and intent.
  • Preparation of 21 CFR Part 11 assessment and compliance Report.
  • Preparation of qualification test protocols (URS, DQ, IQ and OQ).
  • Maintenance of process instruments like temperature sensors, transmitter, level transmitters, pressure transmitters, flowmeters and hart systems.
  • Commissioning and installation of PLC and SCADA automation projects.
  • Troubleshooting of control valve & ON-OFF Valve of Tyco, Fisher, MIL, CVL, Ebro, and Audco make control valve.
  • Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR Part 11.
  • Involved FDA Audit.

PLC Engineer

Vaaman Industries Pvt. Ltd.
Kakinada
01.2013 - 06.2015
  • Development / Modification of PLC Software logic & SCADA System & modification in the hardware set-up for better fault-finding, minimum breakdown, cost saving.
  • Handling Automation system & Instrumentation activities.
  • Preparation of Control Philosophy, IO list and alarm trip schedules.
  • Preparation of System configuration, GA and wiring drawings of PLC panels.
  • Programming PLCs: and designing SCADA.
  • Documented and updated build, quality and performance records.

Sr. Engineer

GI Automation
Hyderabad
06.2009 - 12.2012
  • Study the P&ID or PFD and calculate the I/O budget for Instruments and select the Control System.
  • Study and design the Standby and redundancy system architecture.
  • After the receipt of Enquiry from client, as per the client and process requirement offer submission and follow-up the client and convert the enquiry to PO.
  • Programming PLCs: Schneider-electric Quantum, Premium using Unity Pro XL, L & M, Rockwell-Compact Logix and Control Logix RSLogix500, RS Logix 5000, Siemens S7 300 and ABB AC500-CoDeSys.
  • Experience in Review of P&IDs and designing SCADA using Citect, Vijeo Citect, Wincc and Factory talk view studio.
  • Exposure in handling Automation system & Instrumentation activities.
  • Involved small and big automation projects from erection to commissioning of the projects.

Project Engineer

Microsys Automation
Hyderabad
04.2008 - 06.2009
  • Prepared System configuration, GA and wiring drawings of PLC panels.
  • Preparation of PLC logic using Unitypro XL software according to control philosophy given by Thermax Ltd.
  • Prepared SCADA screens according to P&I drawings.
  • Trends, Alarms and Events are configured according to the database given.
  • Execute Factory Acceptance test for Control System (PLC & SCADA).
  • Field Testing of individual feeders and instruments were completed from SCADA.
  • Established Communication between ABB PLC and Quantum PLC using MODBUS protocol.
  • According to Control philosophy PLC logic tested from SCADA system.
  • Boiler firing Sequence and Modulation Logic is designed in SCADA.
  • Involved in communication, troubleshooting and PID tuning of Control valves of make Fisher.
  • Execute commissioning of PLC & SCADA system.

Education

PGDBA (MBA) -

Symbiosis Centre for Distance Learning
Pune

M. Sc - Instrumentation

Sri Venkateswara University
Tirupati

Skills

  • Understanding of GMP regulations
  • Risk mitigation strategies
  • Effective review skills
  • Team leadership

Accomplishments

  • Audit Compliance
  • Digitalization Projects

Personal Information

  • Date of Birth: 07/07/85
  • Marital Status: Married

Timeline

Sr. Manager

Biologicale E Ltd.
04.2024 - Current

Manager

CuraTeQ Biologics PVT LTD.
08.2016 - 04.2024

Assistant Manager

Mylan Laboratories Ltd (Unit-8)
06.2015 - 08.2016

PLC Engineer

Vaaman Industries Pvt. Ltd.
01.2013 - 06.2015

Sr. Engineer

GI Automation
06.2009 - 12.2012

Project Engineer

Microsys Automation
04.2008 - 06.2009

PGDBA (MBA) -

Symbiosis Centre for Distance Learning

M. Sc - Instrumentation

Sri Venkateswara University

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