Summary
Overview
Work History
Education
Skills
Work Availability
Timeline
MANAS BEHERA

MANAS BEHERA

Lead, Manufacturing & Quality Service, Novartis
Hyderabad

Summary

Leading Operations Service delivery teams and managing delivery of GxP services to assigned geographies and customers, ensuring adherence to defined KPIs and agreed SLAs.Proven Leadership in Manufacturing & Quality Operations with nearly 15 years in Building Strong Internal Business Partners and Win-win Supplier Relationships, while Exceeding Cost Savings Projections, Reducing Cycle Time and Improving Quality of Services.

KEY PROFILE:

  • Enable productivity & offshoring/outsourcing Initiatives for specific business units.
  • Support KPI Tracking/Benchmarking in business functions on the given guidance from Global units.
  • Leading a group 20+ associates and 3 Managers. Experience in operational excellence to meet stakeholder's expectations while ensuring compliance with regulatory provisions.
  • Distinction in managing manufacturing operations team including service transitions, expansion of existing services to new customers, planning and execution of CI initiatives.
  • Manageg resource constraints and lead cost saving opportunities, being accountable for large budget (Project, Infrastructure, plan maintenance)

KEY HIGHLIGHTS:

  • Implemented RPA (Robotic Process Automation) in customer complaints area, which reduced efforts of 10 FTEs from operations.
  • Led a project to centralize quarterly complaints trending for all the manufacturing units and reduced the cycle time from 1 month to 15 days.
  • Led a project on Service footprint expansion to LATAM and worked for a month in Mexico City for establishment of Service center at Mexico City.

Overview

15
15
years of professional experience
7
7
years of post-secondary education
3
3
Languages

Work History

Lead-Manufacturing & Quality Service

Novartis
Hyderabad
10.2019 - Current
  • Establish timely execution of Service Level Agreement (SLA)/Business case and QSC Service catalogue revisions for the responsible services
  • Define and monitor service KPIs to meet service delivery targets, CI targets and take proactive action for improvement on C-Sat survey and other customer feedback mechanism
  • Act as escalation contact point for global and service team on GxP, non-GxP issues and guide team in resolving operational issues and service escalations
  • Prepare and execute all-time audit readiness program through well collaboration between cross functions (manufacturing sites)
  • Drive innovation and entrepreneurial mind set to ensure team members are fully stimulated, challenged and engaged on delivering high quality services
  • Evaluate opportunities and provide right guidance and support to the leadership on centralization of activities in India
  • Guide operational excellence (OpEx) BP in driving performance improvement initiatives by facilitating the implementation of best practices and drive standardization across sites
  • Develop talent, implements succession planning and mentor associates for higher responsibilities
  • Drive operational excellence awareness / culture building within global operations team
  • Support preparation / standardization / execution of OpEx trainings based on customer needs

Operations Expert

Novartis India Pvt Ltd
Hyderabad
07.2014 - 09.2019
  • Measure team KQIs with clear metrics to meet functional objectives
  • Manage technical complaint investigations in co-ordination with CMO and ensure timely closure
  • Implement new working process, which delivered continued process improvements
  • Generate and analyze predefined and ad-hoc reports in various applications (like AGILE PLM, SAP, AQWA etc)
  • Act as SPOC (Single point of contact) for customer on SLA negotiations
  • Review and approve quarterly complaint trending report for all the suppliers under ESO responsibilities
  • Review and Approval of SOPs, protocols, reports, and other documents
  • Impart training pertaining to quality, risk management and compliances to all the relevant stakeholders
  • Manage site QA governance by representing complaint management service
  • Lead Auditor during self-inspection
  • Supplier Quality Management and risk assessment
  • Lead NTO, NCQ-QSC Monthly Governance Board
  • Review of critical quality events in the processes and product like deviations, market complaints and audit CAPAs
  • Successfully faced the audits for various regulatory authorities; received the approval from USFDA & MHRA
  • Liaison with site teams/stakeholders to address the gaps in the practices against standard procedure and in updating the standard procedures as per the updates of regulatory guidelines, as applicable.

Executive

Aurobindo Pharma Ltd
02.2011 - 06.2014
  • Analysis of customer complaints through CAPA approach
  • Implementation of corrective actions and monitoring effectiveness
  • Management of Deviations/ Failure investigations: Assessment of impact of deviations and associated risk, their approval and closure for quality & regulatory compliance
  • Follow up on approved change control procedures to ensure execution is in line with action plan
  • Reviewing completed production batch record and laboratory records before releasing to market
  • Preparation of validation documents and conducting first level review of the same
  • Monitoring the execution of validation/ qualification processes at each stage of manufacturing
  • Reviewed compliance with cGMP norms and system implementations
  • Managed quality management system involving investigating, disposing the incidents, deviations and out of specification (OOS) reports
  • Handled customer complaints with thorough investigation and CAPA
  • Created and send responses along with photographic evidences for CAPA initiated for internal, regulatory and customer audits
  • Prepared new & revision of standard operating procedures related to production activities with required changes if any
  • Worked on relevant documents such as batch manufacturing record and packing record and samples to the customer as needed
  • Change control management: Evaluation, approval and scientific disposition of changes with impact assessment from quality and regulatory perspective.

CIPLA
09.2009 - 01.2011
  • Monitor the online compliance activities during manufacturing operations.
  • Provide line clearances after satisfactory review.
  • In-process checks, sampling of Intermediate, Bulk Finished and Finished Product.
  • Review of batch manufacturing, batch packing and final release of batches for distribution.
  • Implementation of on-line inspection system and procedures.
  • Execution of process validation for new products.
  • Preparation of daily observation report by visiting different areas and departments.
  • Controlled documentation issuance and retrieval including BMR, SOPs, and other controlled
    documents.

Apprentice – QA

Wockhardt Ltd
06.2008 - 08.2009
  • Provide line clearances after satisfactory review.
  • Issuance of controlled documents.
  • Review of batch manufacturing and packaging records.

Education

MBA - Marketing

Osmania University, Hyderabad
01.2017 - 04.2019

Bachelor of Pharmacy (B Pharmacy) - Pharmaceutical Sciences

BPUT
01.2004 - 04.2008

Skills

    Good Communication and Inter Personal Skills with a quest and zeal to learn new technologies & assignments

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Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Lead-Manufacturing & Quality Service - Novartis
10.2019 - Current
Osmania University - MBA, Marketing
01.2017 - 04.2019
Operations Expert - Novartis India Pvt Ltd
07.2014 - 09.2019
Executive - Aurobindo Pharma Ltd
02.2011 - 06.2014
- CIPLA
09.2009 - 01.2011
Apprentice – QA - Wockhardt Ltd
06.2008 - 08.2009
BPUT - Bachelor of Pharmacy (B Pharmacy), Pharmaceutical Sciences
01.2004 - 04.2008

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MANAS BEHERALead, Manufacturing & Quality Service, Novartis