Summary
Overview
Work History
Education
Skills
Personal Information
Languages
Hobbies and Interests
Disclaimer
Inspections Audits
Areas Of Interest
Timeline
Generic

Shivakumar K S

Bangalore

Summary

Seeking a challenging opportunity with a dynamic organization, which contributes growth to self and the organization. To apply my competency and knowledge in emerging quality objectives of company to meet the goals. To be an effective team player in meeting to the company projects and challenges.

Vast experience in leading pharmaceutical companies. Awarded for excellence in facing regulatory inspections and implementation of quality Management Systems in Abbvie, Biocon & Syngene. Awarded for best sterility assurance/ microbiological practices in Strides. Consistently good academic records, good technical and communication skills.

Overview

16
16
years of professional experience

Work History

Senior Manager (Quality Assurance)

Abbvie
Bangalore
07.2020 - Current
  • Led implementation of quality systems across global projects for affiliate.
  • Facilitated regulatory and internal audits while ensuring compliance standards.
  • Directed operational integration, managing change action plans for effective implementation.
  • Established Quality Management System per Quality Manual and regulatory guidelines.
  • Oversaw GxP audits, nonconformance issues, and tracked KPIs efficiently.
  • Managed responses to audit findings during global audits for affiliate sites.
  • Conducted management reviews to drive continuous improvement initiatives.
  • Supervised new product introductions and batch release activities in SAP.

Assistant Manager (Quality Assurance)

Syngene International Limited
Bangalore
01.2018 - 07.2020
  • Leading a team of eight and providing the team with an appropriate environment and support to get the work done.
  • Project lead for the implementation of LMS (SAP SuccessFactors), supporting the implementation of TrackWise, and DMS (Documentum) to enhance the quality systems.
  • Validation of computerized systems (GAMP5, 21 CFR Part 11, EU GMP Annex 11).
  • System Development Life Cycle (URS, FRS, FRA, IQ, OQ, PQ, VP, VSR, and validation deliverables).
  • GXP trainings, as per current regulatory guidance.
  • Handling of Quality Management Systems.
  • Handling regulatory and client audits.

Senior Executive (Corporate)

Mylan Laboratories Limited
Bangalore
12.2016 - 12.2017
  • Implementation of LMS (SAP SuccessFactors) for R&D and corporate functions.
  • Conducting GXP trainings.
  • Preparation and review of training modules for GXP systems, an annual training calendar, and training effectiveness verification.
  • Handling of technical induction training for employees joining the company.
  • Handling audits (internal and external), Quality Management systems.

Assistant Manager (Corporate Quality Assurance)

Biocon Limited
Bangalore
12.2012 - 12.2016
  • Led a team of 2 to drive corporate quality assurance activities.
  • Managed compliance with customer and regulatory audits, including USFDA and PMDA.
  • Implemented quality system policies and standard operating procedures.
  • Prepared, reviewed, and revised Master Validation Plan and Quality Manual.
  • Conducted self-inspections and internal audits to maintain quality standards.
  • Scheduled and facilitated GxP training sessions for staff.
  • Evaluated and qualified vendors to ensure product quality.
  • Oversaw documentation management and control within Quality Management Systems.

Executive (Quality Control -Microbiology)

Agila
Bangalore
11.2009 - 12.2012
  • Performed microbiological testing on pharmaceutical products and conducted water testing for various grades.
  • Led environmental monitoring programs alongside validations for analytical methods and cleaning processes.
  • Ensured sterile area qualifications and executed media fill studies for vials, pre-filled syringes, and dry powder parental products.
  • Investigated failures to determine underlying issues and propose solutions.

Education

Master’s - microbiology

Jnana Barathi Campus, Bangalore University
Bangalore

Bachelor of Science -

S.S.M.R.V Degree College, Bangalore University
Bangalore

Skills

  • Regulatory compliance
  • Quality management
  • GxP training
  • Audit facilitation
  • Change management
  • SAP expertise
  • Stakeholder engagement
  • Problem solving
  • Team leadership
  • Process improvement
  • Document control
  • Communication skills
  • Influencing and negotiating
  • Vendor management
  • Risk assessment
  • Performance metrics

Personal Information

  • Date of Birth: 05/26/87
  • Marital Status: Married

Languages

  • English
  • Hindi
  • Kannada
  • Tamil
  • Telugu

Hobbies and Interests

  • Listening to music
  • Exploring nature
  • Travelling
  • Carrom

Disclaimer

I hereby declare that the above furnished details are true and correct to the best of my knowledge and belief.

Inspections Audits

USFDA, PMDA, MHRA, ANVISA, WHO, MOH Kenya, MOH Namibia, MOH Uganda, MOH Ethiopia, MOH Ukraine, MOH Malaysia, MOH Kazakhstan, MOH Libya, State drug control authority, Karnataka, CDCSO, Drug control general of India, Sandoz, GSK, Aspen, Teva, Mylan, Apotex, Cardinal Health Care, Akorn, Hospira

Areas Of Interest

  • Quality Assurance
  • Computer system Validations

Timeline

Senior Manager (Quality Assurance)

Abbvie
07.2020 - Current

Assistant Manager (Quality Assurance)

Syngene International Limited
01.2018 - 07.2020

Senior Executive (Corporate)

Mylan Laboratories Limited
12.2016 - 12.2017

Assistant Manager (Corporate Quality Assurance)

Biocon Limited
12.2012 - 12.2016

Executive (Quality Control -Microbiology)

Agila
11.2009 - 12.2012

Master’s - microbiology

Jnana Barathi Campus, Bangalore University

Bachelor of Science -

S.S.M.R.V Degree College, Bangalore University

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