Yogeesha Sanil

Experience

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  Cipla

  Aug 2001 - Oct 2016

  Key responsibilities:• Lead Quality Control testing activities (analytical & microbiology) and ensuring GLP compliance of laboratories for manufacturing blocks involved in manufacturing of Oncology OSD & Injectable (liquid & lyophilized) formulations.• Participate and review investigations related to product quality, OOS/ OOT etc.• Manage CAPEX & OPEX budget for assigned laboratories.• Handling regulatory inspections & relevant compliance activities.• Managing & planning commercial launches, new product introductions & technology transfer activities.• Support CQA function in internal audits & vendor audits.• Coordination with R& D and regulatory affairs for timely registration of products. Show less • Manage Quality Control testing activities (analytical) and ensuring GLP compliance of laboratories for manufacturing blocks involved in manufacturing of Oncology OSD & Injectable (liquid & lyophilized) formulations.• Participate and review investigations related to product quality, OOS/ OOT etc.• Manage CAPEX & OPEX budget for assigned laboratories.• Handling regulatory inspections & relevant compliance activities.• Managing & planning commercial launches, new product introductions & technology transfer activities.• Support CQA function in internal audits & vendor audits.• Coordination with R& D and regulatory affairs for timely registration of products. Show less

  • Head Of Quality Control

    Apr 2013 - Oct 2016

  • Functional Head - Quality Control

    Jul 2005 - Apr 2013

  • Section Head

    Sept 2004 - Jul 2005

  • Analyst

    Aug 2001 - Sept 2004
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  Wockhardt Ltd.

  Oct 2016 - Feb 2019

  Key responsibilities include :• Represent & Manage Quality Control operations as Subject Matter Expert.• Drafting & reviewing responses for regulatory deficiencies & queries related to compliance activities of Wockhardt Global Network.• Shop floor monitoring & mentoring to achieve compliance goal along with third party GMP experts. Guide & work with site teams to derive appropriate compliance actions on the gaps identified.• Lead compliance audits across Wockhardt India network and to conduct vendor audits when required.• Review & guide site teams in QMS documentations to meet regulatory expectation.• Coordinate review of regulatory submissions by third party GMP experts & its compliance activities by relevant stakeholders. Show less

  • Deputy General Manager - Corporate Quality Compliance & Remediation

    Jun 2017 - Feb 2019

  • Deputy General Manager - Quality Control

    Oct 2016 - May 2017
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  Aurobindo Pharma

  Mar 2019 - Jul 2019

  Head - Analytical Quality

   Monitor and manage Laboratory Compliance, Quality Management Systems and Continuous Improvement Program  Shop floor monitoring & mentoring to achieve organisational goal.  Guide & work with site teams on investigations and to derive appropriate compliance actions on the gaps identified.  Help and work with laboratory management to plan and execute routine operations

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  SUN PHARMA

  Jul 2019 - Mar 2021

  Deputy General Manager (Head, QC)

  Key responsibilities:• Lead Quality Control Operations and ensuring GLP compliance of laboratory for manufacturing blocks involved in manufacturing of OSD & Non-OSD (liquid & lyophilized injectables, ophthalmic solutions) formulations.• Manage CAPEX & OPEX budget for site quality function.• Managing & planning commercial launches, new product introductions & technology transfer activities.• Support CQA function for continuous improvement and strategic planning for site quality.• Team building and skill development of laboratory staff in alignment with regulatory expectations.• To act as deputy to Site Quality Head for quality & compliance decisions. Show less

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  Abbott

  Mar 2021 - now

  Head, Quality Control (Site)

  Key responsibilities:• Strategic and long range planning with implementation of continuous improvement programs, sustainability monitoring and long term planning• Lead Quality Control Operations and ensuring GLP compliance of laboratory for manufacturing blocks involved in manufacturing of OSD, LVP and Hormone formulations.• Manage CAPEX & OPEX budget for Quality. • Managing & planning commercial launches, new product introductions & technology transfer activities at site.• Support Complaint investigations and Coordinate with R& D and regulatory affairs for timely registration of products.• Team building and skill development of staff in alignment with regulatory expectations. Show less