Anilkumar Gore

Regulatory Affairs-

• Provide CMC support for full life cycle of products, maintenance activities (Variations, Renewals, geographical expansion, Response to HA Queries)
• Develop CMC regulatory strategies for assigned portfolio of products and speed to market in conjunction with country affiliate regulatory teams
• Ensure appropriate prioritization of projects and delivery of high-quality regulatory documents to agreed timelines Provide support to compliance activities viz
• CMC change controls, gap analysis of CMC documents against current regulatory and GMP requirements in association with QA, Supply chain and technical excellence teams
• Review of change controls and other QMS records from Regulatory perspective

Corporate QA:

• Performed internal Audit across strides manufacturing sites and vendor quality audit for qualification of various Raw and Packaging Materials
• Quality Management system- well versed with change controls, Deviations, CAPA and RCIs, Complaints

• Quality Management System: Handling change controls, Deviations, CAPA, RCI
• Organizing change control board meetings for evaluation, assessment of change controls

• Ensuring overall quality for loan license manufacturing/Contract Manufacturing locations for Stantech products
• Performing audits for contract manufacturing sites
• Review of filled batch records such as BMRs, BPRs, QC data
• Travelling to different sites & releasing batches for export as per business requirements.

• Audit Management: (Internal Quality) -Preparation of Audit planner for year for conducting audits for all sites
• Review of regulatory guidelines/warning letters for regular updates and its implementation across site
• Acts as SPOC for global CAPA follow up and its effective implementation across sites
• Successfully completed USFDA, EU audit without any critical/Major deficiency.

• Change management: Facilitate Change Control Board (CCB) meetings and approve changes
• Develop and administer reporting Change Control statistics in site quality review metrics
• Corporate communication: SPOC for communication and Coordinating with SME for performing Gap assessment and communicating to corporate for impact assessments and implementation of corporate procedure at site
• Faced regulatory inspections and have experience in making site audit ready
• Conducted workshop for effective change management procedure& certifying change champions at Hospira- Visakhapatnam

• Quality Management System: Handled Change controls, Deviations, CAPA, RCI in Pilgrim system (21 CFR compliant) and Market complaints, field alert reports, recalls
• Risk assessment and risk mitigation
• Line clearance for manufacturing, filling, and packing activity
• To conduct transport validation for cold chain products
• Handling Process validations, Media fills, equipment validations for Autoclave, Tunnel
• Preparation and review of master batch manufacturing and packing records
• Review of executed batch documents for release of finished products
• Annual product quality review
• Faced regulatory inspections and have experience in making site audit ready
• Handling post approval changes and queries raised by regulators
• Assisting in preparation of dossiers for regulatory department.

• Line clearance & in process checks for injectable & Oral Solid dosage forms
• Involved in aseptic process simulations and filling activities
• Responsible for timely closure of Deviations, change controls and CAPA
• Responsible for online documentation at shop floor.