Summary
Overview
Work History
Education
Skills
Personal Information
Languages
Professional Summary
Timeline
Generic
Srihari M

Srihari M

Hosur

Summary

Results-driven professional with 11 years of experience in Operational Quality, production compliance, and process maintenance in the pharmaceutical and power sectors. Skilled in leading audit readiness for regulatory inspections and managing Quality Management Systems, including Change Controls and Deviations. Experienced in executing CAPA strategies and streamlining operational procedures to enhance compliance and mitigate risks.

Overview

12
12
years of professional experience

Work History

Assistant Manager

BIOCON Limited
Bengaluru
11.2017 - Current
  • Progressed through roles at Biocon Limited.

• Nov’17- Jun’21: Executive (Production-OQT) (Operational Quality Team)

• Jul’21 – Jun’24: Senior Executive (Production-OQT) (Operational Quality Team)

• Jul’24- Till date: Assistant Manager (Production-OQT) (Operational Quality Team)

  • Coordinated document preparation and review with production, engineering, maintenance, and instrumentation teams to ensure compliance and efficiency.
  • Regular plant rounds for customer audits and regulatory audits ensuring operation compliance.
  • Conducted frequent in-house preventive maintenance and calibration verification checks with documentation for equipment used in operations.
  • Managed in-house and customer CAPA processes, facilitating timely resolution of quality issues.
  • Prepared procedures and oversaw QMS documents, including change control and deviations, to maintain regulatory compliance.
  • Harmonization of the procedures across the sites.
  • Simplification of procedures to minimize procedure revision, training hours reduction, multiple QMS document initiation.
  • Review of qualification documents handled for manufacturing operations adhering to regulatory standards and guidelines.
  • Usage of the electronic platform for preparation of documents like DMS for SOP, Track wise for QMS and SAP-SF for training related activities.
  • Support to the cross-function teams in preparation of new procedures based on business requirements.

Graduate Engineer

NTECL
Vallur (Ennore)
12.2014 - 10.2017
  • Growth Path:

• Dec’14-Jun’16: Chemist (Desalination Plant)

• Jun’16-Oct’17: Graduate Engineer (Operations)

  • Ensuring minimal downtime.
  • Allocated 1-2 hours daily for preventive maintenance activities, ensuring operational reliability.
  • Monitoring execution of preventive maintenance including shut down planning.
  • Steering shut down maintenance to ensure trouble-free and seamless operations.
  • Monitored efficiency and performance of RO unit, supporting optimal operation.
  • Managing chemical cleaning of membranes.
  • Identifying areas of obstruction/ defects, conducting troubleshooting, service and repair to rectify the equipment.
  • Maintained accurate stock records to facilitate efficient material flow.
  • Preparing weekly reports to manage the flow of materials for effective utilization.
  • Delivered reports to superiors to facilitate timely and accurate operational decisions.
  • Joint Venture of NTPC&TNEB
  • Reduced downtime by 5% through measures such as 10-16 hrs./week of preventive maintenance activities.
  • Executed modification and upgrade work for pipeline replacement from MS to GRP, enhancing system integrity.

Graduate Engineer Trainee

Seshasayee Paper and Boards Ltd.
Tirunelveli
09.2014 - 12.2014
  • Ensured precise color shade alignment to meet customer specifications.
  • Designed and implemented process improvements for production efficiency.
  • Collaborated with cross-functional teams to ensure quality compliance.
  • Conducted regular equipment maintenance and troubleshooting procedures.

Education

B.Tech. - Chemical Engineering

Sriram Engineering College
Chennai
06-2014

12th grade -

St. Paul's School
New Delhi
05-2010

10th grade -

St. Paul's School
New Delhi
05-2008

Skills

  • Process improvement
  • Data analysis
  • Reporting and documenting
  • Team training
  • Cross-functional collaboration
  • Equipment monitoring

Personal Information

Date of Birth: 03/21/92

Languages

  • Hindi
  • Tamil
  • English

Professional Summary

Result-oriented professional offering 11+ years of a successful career with diverse roles distinguished by commended performance in Operations & Maintenance and Production compliance., Skilled in handling of production and engineering & maintenance documents and involvement in plant rounds during customer and regulatory audits, handling of customer and in-house CAPA preparation and implementation of SOP's and handling of quality management documents like change controls, deviations, imparting training to the end-users on the approved procedures., Review of qualification documents handled for manufacturing operations adhering to regulatory standards and guidelines., Skilled in managing multiple priorities with a bias for action and genuine interest in personal & professional development., An effective communicator., Production, Process, Compliance, Pharmaceutical, Anywhere

Timeline

Assistant Manager

BIOCON Limited
11.2017 - Current

Graduate Engineer

NTECL
12.2014 - 10.2017

Graduate Engineer Trainee

Seshasayee Paper and Boards Ltd.
09.2014 - 12.2014

B.Tech. - Chemical Engineering

Sriram Engineering College

12th grade -

St. Paul's School

10th grade -

St. Paul's School
Srihari M