Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Suryanarayana Swamireddi

Visakhapatnam

Summary

Currently working in Laurus Labs Unit-2, Visakhapatnam as Lead Packing Compliance and Training with total 14.5 years of Rich experience in Pharmaceutical Manufacturing/Packing. Comprehensive problem solving abilities, good verbal and written communication skills, willing to learn and team facilitator, demonstrable creativity in thinking and planning with trained eye for organization development and a passion for competitive ideas, good command of professional knowledge and able to quickly adapt to the new environment and actively participate in the various activities of organization..

Overview

15
15
years of professional experience
1
1
Certification

Work History

Lead, Compliance and Training

Laurus Labs Limited - Unit-2
04.2022 - Current
  • As compliance specialist ensuring site readiness for regulatory authority audits, managing production compliance activities, inspection readiness, post inspection remediation.
  • Participate in all audits & facilitate timely delivery of documents to facilitate efficient inspection program.
  • Participate with cross functional & leadership team to prepare responses in a timely manner for deficiencies received from regulatory agencies.
  • Tracking and ensure effectiveness of CAPA with respect to audit recommendations.
  • Gap assessment at site against regulatory audit observations.
  • Data integrity process mapping, culture change, people development by providing training to shop floor personnel.
  • Self-inspection lead for assessing adequacy and adherence to quality systems, procedures and requirements.
  • User ID & password management.
  • Review of audit trials of equipments and instruments.
  • Review of log books and BPR's.
  • Identify and monitor training needs in department and design, plan and implement training programs, and procedures.
  • Determine and seek individual development training requirement through co-ordination with all type of trainings.
  • Conduct orientation program for new hires in collaboration with hiring managers.
  • Training facilitation and delivery of instructor led trainings across department.

Supervisor Cum Shift In-charge

Laurus Labs Limited - Unit-2
11.2021 - 04.2022
  • Ensuring effective operations of packing.
  • Execution of Production Plan as per weekly and monthly planning.
  • Handling shifts manpower and allocation of work as per daily packing plan.
  • Coordinating all maintenance activities and validation activities in packing area in compliance manner as per SOP.
  • Planning, scheduling and executing of validation activities like FAT, SAT, IQ, OQ, PQ.
  • Executing Process validation batches.
  • Co-coordinating with CFT members to act on time to meet business requirements.
  • Preparation, review of Sop's.
  • Review of batch release documents related to Packing.
  • Shop floor trainings on equipment’s, procedures and Presentations on study protocol activities to peers and other colleagues.
  • Handling of deviations related to packing activities.
  • Stock verification in SAP and maintaining the required stock as per planning.
  • Material management through SAP.
  • Updating daily reports like RTE, C/O time.
  • Active participation in audit preparations.

Packing Supervisor

Pfizer
02.2015 - 10.2021
  • Ensuring effective operations of packing.
  • Execution of Production Plan as per weekly and monthly planning.
  • Process simplification by using DMAIC approach.
  • Ensuring day to day compliance.
  • Improving efficiency of lines by analyzing losses and taking actions to mitigate.
  • Handling shifts manpower and allocation of work as per daily packing plan.
  • Coordinating all maintenance and validation activities in packing area in compliance manner as per SOP.
  • Planning, scheduling and execution of qualification activities like IQ, OQ & PQ.
  • Executing Process validation batches.
  • Co-coordinating with CFT members to act on time to meet business requirements.
  • Motivating colleagues on JDI (Just do it), RFT (Right first time) and reporting near miss, Unsafe conditions and unsafe behaviors.
  • Preparation, review of Sop’s.
  • Review of batch release documents related to Packing.
  • Shop floor trainings on equipment’s, procedures and Presentations on study protocol activities to peers and other colleagues.
  • Handling of deviations related to packing activities.
  • Investigation of incidents and CAPA implementation.
  • Handling of market complaints,
  • EBR execution through MES (Manufacturing Execution System) AMPS.
  • Stock verification in SAP and maintaining required stock as per planning.
  • Material management through SAP.
  • Updating daily reports like RTE, C/O time in DOC (Digital operation center)
  • Active participation in audit preparations like USFDA.
  • Qualified trainer & training administrator for imparting all kind of trainings.

Senior Technical Assistant

Aurobindo Pharma Unit III
05.2013 - 02.2015
  • Operation & troubleshooting of packing equipments such as cartonator, online check weigher, Tamper evident labeling machine etc.
  • Calibration of weighing balances on daily and Quarterly basis.
  • Raising work order to engineering incase of any break down.
  • Status labelling.
  • Equipment cleaning.
  • line clearance through LLC concept.
  • Proof verification, Start up & in process checks and challenge tests.
  • Batch closing, Reconciliation etc.
  • Highest output with lesser break downs.
  • Online documentation.
  • Equipment qualification.
  • Manpower handling.
  • Achieving the weekly & monthly planned volume.

Junior Officer

Eisai Pharma
01.2011 - 05.2013
  • Operation & troubleshooting of packing equipments such as cartonator, online check weigher, carry strapping machine etc.
  • Involved in all manufacturing activities such as raw material dispensing, milling, Granulation, Blending, Compression, coating, coating solution preparation and tablet inspection.
  • handled three secondary packing lines alone they are blister, bottle & bulk packing.
  • Creation and generation of shipper labels using bartender software.
  • Calibration of weighing balances on daily and Quarterly basis.
  • Raising work order to engineering incase of any break down.
  • Status labeling.
  • Area & Equipment cleaning.
  • line clearance.
  • Proof verification, Start up & in process checks and challenge tests.
  • Batch closing, Reconciliation etc.
  • Highest output with lesser break downs.
  • Online documentation.
  • Equipment qualification.
  • Manpower handling.
  • Achieving the weekly & monthly planned volume.

Junior Technical Officer

Dr.Reddy's Laboratories
07.2009 - 01.2011
  • Operation & troubleshooting of secondary packing equipments such as cartonator, online check weigher, carry strapping machine etc.
  • Creation and generation of shipper labels using bartender software.
  • Calibration of weighing balances on daily and Quarterly basis.
  • Raising work order to engineering incase of any break down.
  • Status labeling.
  • Area & Equipment cleaning.
  • line clearance.
  • Proof verification, Start up & in process checks and challenge tests.
  • Batch closing, Reconciliation etc.
  • Highest output with lesser break downs.
  • Online documentation.
  • Equipment qualification.
  • Manpower handling.
  • Achieving the weekly & monthly planned volume.

Education

Master of Science - Chemistry

Dr.B.R.Ambedkar Open University
Hyderabad, TG
05.2017

Bachelor of Science - Drug Chemistry And Drug Technology

Dr.B.R.Ambedkar Open University
Hyderabad, TG
05.2012

Diploma - Pharmacy

State Board of Technical Education And Training
Visakhapatnam, AP
03.2008

Skills

  • Data-driven decision-making
  • SME for Pharma Packing
  • Team leader
  • Track & Trace, Serialization
  • Document review and Approval
  • Document control
  • Compliance
  • Presentations and demonstrations
  • CFT Management
  • Reporting management
  • Deviation/Incident handling
  • Data Integrity
  • Change control
  • CAPA
  • Market complaints
  • Investigations
  • Internal audits
  • Audit preparation
  • SOP Preparation & review
  • SOP Harmonization
  • Process simplification
  • Continuous improvement
  • Operations planning
  • Cross-functional communication
  • Planning and coordination
  • Training initiatives
  • Train the trainer
  • Training & Development
  • Company policies and procedures
  • Manufacturing
  • MS office
  • SAP Production Module
  • Compliance
  • Impact assessment

Certification

  • Received best Technical Associate award in 2010 from Dr.Reddy’s Laboratories.
  • Received KAIZEN award in 2013 from Eisai Pharma for the simplification of packing process.
  • Received Pfizer’s Recognition award in 2019 for the simplification and harmonization of Packing Sop's.
  • Received Pfizer’s Recognition award in 2020 for the on time completion of SOJT trainings for the new hires.
  • Received Pfizer’s Recognition award in 2021 as a best GMP trainer.

Timeline

Lead, Compliance and Training

Laurus Labs Limited - Unit-2
04.2022 - Current

Supervisor Cum Shift In-charge

Laurus Labs Limited - Unit-2
11.2021 - 04.2022

Packing Supervisor

Pfizer
02.2015 - 10.2021

Senior Technical Assistant

Aurobindo Pharma Unit III
05.2013 - 02.2015

Junior Officer

Eisai Pharma
01.2011 - 05.2013

Junior Technical Officer

Dr.Reddy's Laboratories
07.2009 - 01.2011

Master of Science - Chemistry

Dr.B.R.Ambedkar Open University

Bachelor of Science - Drug Chemistry And Drug Technology

Dr.B.R.Ambedkar Open University

Diploma - Pharmacy

State Board of Technical Education And Training

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Suryanarayana Swamireddi