Amal Saji

Experience

• 

  Bharat Petroleum Corporation Limited

  Mar 2018 - Mar 2018

  Inplant trainee
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  Tagros chemicals india (p) ltd

  Feb 2019 - Feb 2020

  Graduate Engineer Trainee

  o Monitoring and Calculation of Power, Steam & Water, BPR review, QMS related work include change control, deviation, incident, SOP revision, BPR revision & compilation of validation.o Ensuring online documents up to date, Preparation of daily report and monthly report, handling of SAP & dispatch activities.o Walking around the production floor at regular intervals to ensure everything is in order.o Making sure that only quality material is used in the production process.o Monitoring plant production to ensure consistent material flow and qualityo Reporting on a regular basis to senior managers. Show less

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  R L Fine Chem Pvt. Ltd.

  Oct 2020 - Dec 2021

  Officer

  o BMR review, supporting QMS work include change control, deviation, incident, SOP revision, BPR revision and compilation of validation.o Handling of ERP, ensuring online documents up to date and monitoring production yield and quality.o Checking the accuracy of product specifications.o Walking around the production floor at regular intervals to ensure everything is in order.o Making sure that only quality material is used in the production process.o Reporting on a regular basis to senior managers.o Monitoring plant production to ensure consistent material flow and quality. Show less

• 

  Biocon

  May 2022 - Mar 2024

  Executive

  o To coordinate with QA for all the validation, qualification and Audit preparedness. o Preparation/Reviewing of all quality related documents in applicable software.o Provide necessary support to other department as a CFT.o Preparation / reviewing of protocol and reports including URS, equipmentqualification, risk assessment, study protocol, etc., along with coordination of CFT. o Responsible for assessing the gaps on existing quality documents / Records andresolve issue with proper QMS documents.o Initiation, coordinating CFT and providing supporting documents for all QMSrelated documents (Change control, deviation, OOS, OOT, CAPA, auditmanagement, Etc.o Indent and receiving the BMR, ECC, Checklist, logbooks, annexures, etc., forexecution. Review and submission of executed documents like BMR, ECC, checklist, logbooks, annexures etc., to QA. Responsible for document archival related to manufacturing.o Responsible to coordinate with internal auditors and provide necessary documents. o To formalize the study / non-routine study proposed by the team and reportgeneration, responsible for complete workflow.o Authorized to initiate the PRN and material destruction activity.o Handling of Preparation, Review, Approval and Issue of Standard OperatingProcedures.o Handling EHS violation and Process safety management.o Coordination with EHS for completing Prestart up safety review.o To specify the requirement of zone classification during initial stage (URS) ofequipment installation/project initiation.o Authorized for imparting training in QMS documents to own departmentalemployees and other department employees.o Preparation of applicable documents for change controls such as risk assessmentsetc.o To provide CAPA, follow up, implementation and harmonization of the auditfindings in co-ordination with the end user (Production, Engineering & Maintenance and Instrumentation). Show less