Harish Khade

Experience

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  Johnson & Johnson

  Aug 2005 - Dec 2013

  Senior scientist, Quality Assurance , Analytical R&D

  1.Responsible for Quality system management for regulated market products.2.Qualification and Re qualification of contract testing management. 3.Responsible for stability management of skin care, oral care & hair care products with various dosage forms liquid, lotions, creams, gels in US and Europe market.4.To conduct root cause analysis to investigate deviations and effectively implement CAPA action plan.5.To ensure all major changes are timely captured in Change control process.6.To support timely release of finish products by resolving technical related issues.7.To prepare, maintain and update technical documents such (e.g.: Stability reports, Method Validation/ development protocol, SOPs, Method transfer, reference standards).8.To plan, monitor, review stability studies at Third party organization and ensure compliance.9.To execute and review Analytical stability management of marketed and R&D products using instruments like HPLC, GC, UV-IR etc.10.To perform Analytical method validation on new drug substances, drug products.11.To perform Force degradation study on OTC products to evaluate process impurities or unknown impurities.12. To prepare stability close out reports for 24M studies.13.To review and optimize calibration and maintenance program (IQ, OQ, PQ) of laboratory equipments as per cGMP compliance.14.To train and qualify new team members on quality, compliance, GMP and instrument techniques.15.Maintain and review laboratory notebooks, electronic data collection/storage software, instrument logbooks, training records, etc.16.Participated in two US-FDA audits and understood the requirements. Achievements: 1.Recognized with Silver award in Innovation pillar logo contest conducted all over Asia pacific region.2.Recognized with best team performance for yr. 2010-11.Achieved 90% score in Certificate program of Laboratory Analyst Training Certification Program (LATCP) and cGMP from Drew University, NJ, USA Show less

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  GSK Pharmaceuticals India

  Jan 2014 - Sept 2018

  Asst. Manager, External supply Quality

  Quality Compliance and Risk Management:1.Implement and Manage Quality Management Systems (QMS) for External Supply Quality. 2.To ensure timely completion of Change control, Deviation and CAPA (Trackwise). 3.Efficient data lifecycle management and archival. 4.Lead Quality Improvement and cost optimization projects.5.To Work with business areas to ensure risk are identified, analyzed, evaluated and controlled.6.Ensure all required risks are recorded and maintained in RMS.7.Run RMS process review and summery chart for use at the RMCB meetings.b. GSK Certified Quality auditor:1.Planing and execution of external audits and CAPA compliance.2.Lead Internal Quality inspection team to ensure continuous improvement in the level of compliance to meet regulatory and corporate compliance standards and requirements.3.Responsible for management of self-inspection audit program4.Perform cross-functional Risk based Audits (IBM)5.Ensure timely issuance of audit reports, CAPA plan, Review RCA and CAPA proposed by the auditee. Check CAPA effectiveness.6.Support the preparation and hosting of Compliance Audit Group, Audit and Assurance team and regulatory inspections.7.Perform periodic review on audit trends to ensure Risk are identified and manage correctly.8.Verify that applicable CAPA has been delivered as committed.9.Support continuous improvement projects to reduce costs, increase productivity and improve quality.10.Develop audit universe and schedule.Achievements: 1.Received a GPS champion medal for successfully implementing GPS tools to resolve low assay issue in Calpol Suspension.2.Received Bronze award to identify and mitigate low assay issue in one of the Tier 1 product.3.Received Silver award for onsite support for analytical method development and transfer for Neosporin H ear drops.4.Received Bravo award for executing long pending Method development/ validation/ transfer of ointment product. Show less

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  Novartis

  Oct 2018 - Jan 2020

  Manager QA , External Supply Organisation, India Export

  1.Single Point of Contact for all quality related activities at approved CMO’s for export business.2.Accountable for Implementation and review of Quality system implemented and maintained at Cortical CMO’s as per Novartis expectations.3.To implement the KQI based quality over site module at ESO and monitor on monthly basis.4.To engage and support to global quality team for new product launch. 5.To support audit and compliance team in review and follow up of CAPA actions and timely closeout.6.Responsible for driving / initiating External Supplier Quality Risk management to be carried out for all External Suppliers. Gaps in Quality Systems to be identified with an evaluation of the associated risks. 7.Ensure that a valid QA agreement defined in line with Global template is in place and in use.8.Manage critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement and the Novartis Quality Manual. 9.Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Support / participate in Novartis Emergency Management cases as required.10.Ensure that Change requests, either from the External Supplier or from Novartis, are managed and closed .11.Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance. Show less

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  BIOCON LIMITED

  Jan 2020 - Sept 2022

  Associate QA Manager

  1.Responsible to ensure end to end Quality management systems implemented and maintained at contract manufacturing sites.2.Planning and execution of external suppler audits of raw material and packaging material and CAPA compliance.3.Periodic Quality management review of approved CMO/ vendors.4.Supplier Quality over site and Key Quality indicators monitoring of approved vendors.5.Change control management, Deviation management, Audit and CAPA management and complaint management in TrackWise system6.Qualification and Re-qualification of new RM, KSM ,Intermediate vendors. 7.Responsible for Quality agreements management.8.Responsible of Qualification and re qualification of Contract testing laboratories. 9.To resolve material quality issues and non-conformance in co-ordination with Supply chain team10.To engage and support Customer Regulatory audits.11.To collaborate with Supply chain, Procurement, Business development in strategic decisions for continuous supply.12.Handle critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) according to the Quality Agreement. 13. Assessing quality trends and driving continuous improvement for processes and product quality performance. Show less

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  DHL Supply Chain

  Sept 2022 - Jul 2024

  Head of Quality Assurance

  Responsible for QMS implementation as per ISO 13485 standards for all Lifescience accounts PAN-INDIA