Siddesh Mankame

Experience

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  Merck Group

  Jun 2005 - Dec 2005

  Quality Control Executive

  - Performed Sampling and testing of raw material & packing materials. - Team member in quality excellence project for reducing lead time from sampling to release of products. - Support Member of site calibration and analytical service team to ensure timely calibrations of all Quality control instruments

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  Sanofi

  Nov 2007 - Sept 2014

  Asst. Manager Quality Assurance

  Responsible for Management of Quality Assurance Documentation & core activities such as Change Control & Deviation Investigations & CAPA management and Risk assessment as per ICH Q9.Responsible for Shop floor Quality Assurance related activities such as In-process quality control, Machine Qualifications and Process Validation.Faced Various Regulatory Inspections such as MHRA, TGA, WHO, ANISA, EUGMP & Global Audits

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  Johnson & Johnson

  Sept 2014 - Oct 2016

  Asst. Manager Business Quality

  As Site Quality Lead Handling Quality System and Products Complaints for J&J & TPM manufacturing sites in India. India Lead for Managing Change Control, Deviations, Recalls & Returned goods investigations.Collaborating across functions such as site quality, regulatory, pharmacovigilance, sales & marketing etc. to ensure a detailed root cause analysis is performed ensuring an appropriate CAPA.

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  Sanofi

  Nov 2016 - Aug 2017

  Quality Projects Manager China

  As Site Quality Projects ManagerEvaluation of sites procedures with respect to EU GMP and WHO Guidelines vis a vis Sanofi Global Quality Standards to identify & close the gaps.Developed a processes for tracking Change Control implementation, Deviation closure and CAPA implementation ensuring >90% on-time success rate.Developed & Integrated Human Error Reduction (HER) tool with the Root Cause Analysis in Deviation Investigations.Successfully completed the EU GMP Inspection with No critical observations for Site Show less

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  Abbott

  Aug 2017 - May 2023

  ➢ Led the planning and execution of comprehensive audits for raw material vendors and external manufacturers of finished dosage forms, ensuring stringent adherence to GMP and regulatory standards while enhancing overall quality assurance activities.➢ Acted as the primary liaison between Procurement, R&D, vendors, and third-party manufacturing sites, effectively facilitating the closure of audit observations and driving cross-departmental communication to ensure compliance with quality requirement.➢ Supported internal manufacturing sites in preparing for EU GMP and other regulatory inspections, ensuring readiness and compliance with all quality standards through thorough documentation and proactive measures.➢ Directed cross-functional teams in evaluating investigations, identifying root causes, and establishing corrective and preventive actions (CAPAs), significantly reducing repeat product and material failures through effective problem-solving strategies.➢ Monitored supplier performance trends, escalating significant issues to senior management during Management Review Meetings (MMR), fostering accountability and driving continuous improvement initiatives across the supply chain.➢ Championed quality improvement projects that systematically reduced material rejections by coordinating timely actions with manufacturing sites and external vendors to enhance product integrity.➢ Facilitated the digitalization of vendor approval requests, streamlining documentation processes to enhance operational efficiency and improve return on investment (ROI), aligning with organizational goals for quality excellence. Show less

  • Regional Manager Quality & Compliance (Grade 16)

    Apr 2019 - May 2023

  • Regional Quality Assurance Manager (Grade 15)

    Aug 2017 - Apr 2019
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  Novo Nordisk

  May 2023 - now

  Sr Manager Quality

  ➢ Drive Global and Regional Quality Initiatives: Spearheaded quality ambitions across the India affiliate, fostering a strong quality mindset within the organization to enhance compliance and operational excellence.➢ Supported the development and execution of a GxP Quality Operating Models, enhancing cross-functional collaboration and ensuring sustainability of quality practices.➢ Team Leadership and Development: Led and mentored a team of complaint investigators, providing guidance and support while establishing performance expectations. Monitored daily improvements to enhance team efficiency and effectiveness.➢ Operational Excellence Strategies: Developed and executed strategies for internal and cross-functional initiatives, effectively managing project timelines and priorities to drive quality improvements across the organization.➢ Process Improvement Initiatives: Implemented process improvement initiatives that fostered a culture of continuous improvement and customer-centricity within the team, aligning with organizational quality objectives.➢ Regulatory Compliance: Actively participated in audits and assessments, providing comprehensive documentation and information on complaint management processes to ensure adherence to regulatory standards.➢ Complaint Management Oversight: Managed the quality complaint process, ensuring strict compliance with applicable procedures, laws, and regulations. Conducted both standard and advanced investigations to identify root causes and implement corrective actions. Show less