Harshal Suke

QMS - Complaint Management:

• Responsible for handling of Technical Market complaints and processing e-QMS (GxQEM).
• Review the receive complaint and process for supplier investigation (CMO).
• Co-ordinate for complaint sample, additional information (if required), periodic follow-up with CMO.
• Review the received investigation from supplier and perform in e-QMS (GxQEM).
• Perform QA role for assigned complaints, management of child records, perform final review and complaint closure.
• Responsible for managing and processing the disproportionate LOE signal cases.
• Responsible for Monitoring CAPA and Effectiveness check related to Complaint CAPA.
• Preparation of Monthly and Quarterly Dashboard data (Quality Metrics) related to QMS (Deviations, Batch release and Market Complaints).

QMS - Product Release Support:

• Batch Record review and Batch release support.
• Generate and analyze predefined and Ad-hoc reports in various applications (SAP, TrackWise, GxQEM, CONDOR, Sharepoint and sharefolders etc.).

QA-QMS & Training management:

• Quality Management System (QMS), SOP Authoring & Publishing (SOP Management) and Technical Trainer (GLMS) Training Management.
• Handling of QMS events via QMS TrackWise (Change controls, Deviations, CAPA, Audit report and Audit Response).
• Execute Internal Audits (Audit Agenda preparation, Document review, process demonstrations, system review, report preparation) and support regulatory audits (HC, USFDA, MHRA etc.).
• Qualified Trainer for Program like cGMP, Data integrity, QMS process trainings and QMS-TrackWise (Change Control), LiveLink, Content Servers and SAP.
• SAP and TrackWise superuser.

Global Quality Learning Operations:

• Trained operations and site training representatives on the establishment, maintenance, and monitoring of Training Plans for stakeholders in Canada, Australia, New Zealand, USA, Mexico and Asian region.
• Collaborated with business units to meet training needs by maintaining training records, investigating plan discrepancies, and generating customized SAP reports.
• GLMS superuser: Updation, Removal or creation of Site, Function and Role specific curricula/curriculum.
• Conducted periodic reviews of Training Plans to ensure compliance and effectiveness in supporting stakeholder requirements.

Global Quality Technical Operations:

• Prepared and reviewed Master Batch Records (MMaR/MPaR)
• Initiated Unblocking/Blocking in SAP
• Published documents in SAP and Content Server
• Migrated MPPDs into new MMaR & MPaR templates
• Worked on MMaR execution in POMS Software
• Supported in the implementation of Manufacturing Execution System (MES)
• Reviewed SSR, SLE, and ASR
• Updated CofA in LIMS

PMO:

• Developed and maintained organizational charts for all functions within the organization
• Drafted and Reviewed SLA & QTA with External and Internal Stakeholders
• Managed dashboard data for fortnightly and monthly performance metric reviews
• Created performance review metrics and Monthly Progress Review (MPR) data
• Reviewed Operational (OP) and Continuous Improvement (CI) Actions
• Led Project Transitions and calculated FTE, AHT, CPU (Capacity, Productivity and Utilization)
• Conducted Process Mapping and implemented Kaizen Projects for process monitoring and productivity improvement

• Managed SOPs by evaluating changes, assessing their impact, implementing changes, and closing change requests as QMS-Change Control Coordinator
• Prepared, reviewed, published, and provided training in GLMS for SOP/WI
• Updated Quality Technical Agreements (QTA), Site Master File (SMF), and list of Quality Agreements
• Oversaw pharmaceutical manufacturing unit operations.

• Reviewed and executed Batch Manufacturing Records (BMR/BPR) and performed batch release activities in Metis ERP
• Reviewed Master Batch Manufacturing Records (MBMR), SOPs, and Protocols
• Conducted in-process and finished product sampling in accordance with SOP or validation protocols
• Inspected oral solid products for bulk approval for packing using AQL inspection as per SOP
• Provided overall QA oversight for ensuring effective implementation of cGMP during pharmaceutical product manufacturing process and reported non-compliance
• Conducted line clearance activities at various stages of manufacturing process
• Prepared Monthly, Quarterly, and Annual Quality reports for Quality Matrix

• Completed training on Fundamentals of Chemistry, QC Lab Overview, Basic Tools of Analytical Chemistry, and basic Analytical techniques
• Received hands-on training in handling FTIR, UV, Dissolution Apparatus, HPLC, GC-MS, Polarimeter, and other commonly used QC instruments
• Participated in training on Spectroscopic Methods of Analysis, including theory and practical application
• Completed training on Regulations & regulatory environment in the Pharmaceutical Industry
• Received training in Statistical tools for the Pharmaceutical Industry and SOPs
• Completed training on Teamwork and quality as a way of life in behavior and practices