Ravindra More

• Commercial & Distribution Quality Assurance & Pharmacovigilance handling Quality and Pharmacovigilance operations for India region., (Specialization in Imported Ophthalmic products):

Commercial and Distribution QA:

• Warehouse management – Management/execution of quality operation/activities for Santen affiliate and its warehouses in India to ensure its compliance with applicable local regulatory authority and Santen requirements for importation, local testing, repackaging, storage, and distribution of Santen products
• Audit management – Performing audit of Warehouse, and Distributor for applicable GDP regulations
• Performing Self-Inspection of Santen Internal functions
• Product release of imported consignments for distribution
• QMS system management – Evaluation of change controls, Deviations, CAPAs for India region and monitoring the closure of each
• Computer System Validation expert (CSV COE) for Asia region – Currently working with global team to harmonize and develop Robust Computer System Validation processes / systems for organization
• Reference standard management – Arranging reference standards from Japan plant for testing during Local release by ADC (Assistant Drug Controller)
• Local testing Management – Collaborating with SCM and arranging for local testing of product as per ADC request
• Providing all the documents required for testing and follow up with Laboratory for release
• Provide relevant quality input/support to business initiatives/projects, new product introduction, product launches and product variation in India
• Artwork verification of products for any new change for the region
• Training management – Training the India region employees/Warehouse employees on the day-to-day operations, SOPs and processes
• SOP Management – Keeping all the SOPs of QA and PV function effective for use and updating them as per requirement
• Global Projects – Participate in Global SOP and Policy document preparation and finalization

PV Operations:

• Developing, implementing, and maintaining Pharmacovigilance System Master File (PvMF) and act as a Pharmacovigilance Officer in-charge (PvOI) for Santen India
• Performing Safety Reporting (e.g
• Domestic AEs, Foreign SUSAR, Periodic Safety Update Reports etc.) to Health authority to ensure 100% of compliance in submission
• Performing local literature search for the purpose to identify suspected adverse reactions on a regular basis
• Conducting safety communication to health care professionals and Health authority in India
• Planning of risk management plan including post marketing surveillance for new products
• Conducting post marketing surveillance including vendor management and investigator management
• Post Marketing Surveillance (PMS) – Performed project lead for Phase -IV clinical trial (PMS study) for one of the new product to be launched in India
• Managing Safety Vigilance regulatory inspections and/or audits
• Performing safety vigilance and Quality management review and implement necessary plan for improvement
• Planning local QA/SV budget as well as providing necessary inputs in forecasting.

• Handling of market complaints and product queries – End to end monitoring of market complaint at corporate function
• Seek Technical guidance from cross functional team to resolve the complaints and identifying exact root cause
• Review of CAPA provided and evaluation to avoid reoccurrence in future
• Monthly update of complaints for regional and global review/escalation
• Review of repetitive complaints along with manufacturing location and participate in further action plan
• Reconciliation with Pharmacovigilance team on medical complaints received
• Resolution of product complaints issues received for products by coordinating with cross function teams
• Handling of Product recalls – Monitoring complete activities related to product recalls
• Handling of Regulatory Complaints, NSQ reports, regulatory deficiency and responding along with Regulatory team
• Audit management – Playing role of auditees at regional audits, supporting manufacturing site and pharmacovigilance in Audits
• SME for Complaints and recalls and periodic review of SOPs
• Certified trainer for training to Cross functional and 3PLs on complaints and recalls
• Supporting Marketing team on product-based knowledge and quality proven innovations for better promotion.

• Handling of Product recalls, Field Alert report (FAR) – Monitoring complete activities related to product recalls & FARs
• Governance and monitoring of BPOs (Bioclinica) for Customer complaint handling process and quality metrics
• Vendor Qualification, Audits of new BPOs for customer complaint handling process.
• Guidance to manufacturing location for investigation and identifying exact root cause
• Guidance/Training to Cross functional team on effective complaint handling and resolution
• SME for Complaints and recalls and periodic review of SOPs
• Audit management – Playing role of auditee at regional audits, supporting manufacturing site and pharmacovigilance in Audits
• Reconciliation with Pharmacovigilance team on medical complaints received.

• Handling of Market complaints, product queries, Recalls and FARs for US, Europe, ROW and India market
• Team Manager for 4 direct reports and effective people management
• SME for Complaints and recalls and periodic review of SOPs
• URS development of Complaints module in Trackwise system
• Continuous Quality system Improvement Initiatives from 483 citations from GMP trends, Warning letter, Nonconformance reports, etc
• Internal Audit reports and CAPA review of Cipla manufacturing units for harmonization of cGMP requirements
• Gap Analysis of current regulatory guidelines and Quality improvements in Cipla’s systems
• Audits of Third party warehouses of Cipla and maintaining compliance of the warehouses as per local regulations
• Reviewing of Change controls, Deviations and CAPA applicable to job functions
• Harmonization of Quality initiatives at different Cipla locations
• Audits of Contract Laboratory - Audit Report review, CAPA review, etc
• Third Party product Release management – Review of testing results, Manufacturer COAs and final release of products for distribution.

• IPQA Activities, BMR & BPR preparation and issuance, etc.

• In-process Analysis, Finish goods analysis, calibration of instruments, etc