Yunus Shaikh

Experience

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  Medley Pharmaceuticals Ltd

  Aug 2005 - Jun 2007

  Production Officer

  - Manufacturing and Packaging of Liquid and OSD.- Execution of export orders, Inventory control, Manpower planning

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  Shreya Life Sciences Pvt. Ltd.

  Jul 2007 - Sept 2008

  Research and Development Officer

  - Formulation & Development for dosage form such as Tablets, Capsules & Ointment.- Preformulation studies, Stability studies - Technology Transfer

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  Sun Pharmaceutical Industries Ltd

  Sept 2010 - Dec 2013

  Corporate Compliance Officer

  - Audit and Compliance ERP Application system - Quality Management System

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  Cipla

  Dec 2013 - Oct 2014

  Management Staff - Regulatory Compliance

  Ensures the quality functions of the Pharmacovigilance Department/ Regulatory Compliance. Review of the PSUR, PADERS to be submitted to the various regulatory agencies like DCGI, USFDA, and EMA. Review & process change control proposals received from Pharmacovigilance Department and units. Conducting periodic audits of Pharmacovigilance Department.Prepare report for regulatory compliance assessment & follow-up on actions identified.Keep track of activities to be completed regulatory as a part of regulatory commitment. Show less

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  Watson pharma - Teva Pharma

  Oct 2014 - Feb 2017

  Senior Executive - Corporate Quality Operation

  Role in Supplier Quality Compliance for API and Formulation unit suppliers/vendors. Review of vendor checklists, vendor registration forms, and sample request form for register of vendor.Evaluation of documents received from the vendor and updating in global database Scheduling audits for new development projects or as per frequency of the audits.Participate in due diligence audits review and release of vendor for procurement based on audit compliance. Perform desktop audit, and Updating records in the SAP and Trackwise, Approval of change control related to packaging specifications. Review/ Harmonize In house Corporate SOP, Forms, QA documentation; and ensuring adherence to compliance. Training on the Corporate Procedures or QMS to respective Stake Holders. Show less

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  Torrent Pharmaceuticals Ltd

  Feb 2017 - Sept 2020

  Assistant Manager - Quality Data Reliability

  Audit And Compliance Plan and conduct DI Unscheduled/Internal Audit and For Cause Audits of API and Formulation Units. Conduct monthly Data Integrity Self Inspection of identified departments in the site. Perform Gap Assessment of procedures / practices to identify DI risk and compliance with requirements of regulatory guidelines. Review of audit trails (System/Product specific) of SCADA/IPC/HMI based equipment / software’s.Evaluate / Implement effective corrective and preventive action (CAPA) for the non-compliance identified in respective audits. Conduct awareness training and guidance on Data Integrity and Part 11 compliance.Review Gap assessment of Instrument, Equipment and Utility software’s to comply with 21 CFR Part 11 and EU Annex 11 requirements. Risk assessment, evaluation, communication and follow up for mitigation action plan. Review and approve system privileges, CSV OQ, change controls, deviation, VSR, RTM to comply 21CFR part 11 compliance and EU Annex 11 requirements. Learnings on Quality operations, Data Integrity issues/updates, 483’s, warning letters and implementation in Corporate Policy/ SOP’s. Show less

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  Piramal Pharma Solutions

  Sept 2020 - Aug 2021

  Manager- Data Integrity
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  Par Pharmaceutical

  Sept 2021 - now

  Manager - Data Integrity compliance (Enterprise Quality Audits)

  Audit and Compliance, Data Integrity complianceInternal Site audits, Vendor Audits, CMO audits, Vendor Qualification