ANIL ASHOK MACHCHA

Results-driven leader with positive attitude and passion for providing high-quality advice and guidance to clients. Proven ability to identify customer needs, resolve conflicts and build strong relationships. Possesses excellent problem-solving, communication and interpersonal skills.

• Successfully involved with WHO, MHRA, USFDA, TGA, MCC Audit in Cipla Ltd. and USFDA Audit in Dr. Reddy's Lab.
• Successfully worked on yield improvement and reduction in rejection.
• Knowledge of Requirement of cGMP and worked on internal & external Audits.
• Independently developed auditor view and acquired a knowledge of process validation, exhibit & validation batches.
• Actively participated in various audits and self-inspection including Global Clinical Supply Audit.

• Compression machine and other Packing machines
• Blister Pack machine -Rotovac-210 plus, Pharmapack-240 CH, Elmach-2030, BQS (Pam make), PGExpress
• Cartonators - Cam cartonator, HV-cam cartonator, IC-150 (Pam make)
• Strip packing machine (Satellite make), Marchesini (Italy Make)
• Pharma industry IT tools

• 1-Dec-2020 to till date (Global Quality Manager), 12/01/20, Present, Technical expertise supports new product development, Risk Management, Supporting qualification and facility upgrade activities, IT validation projects, Managing development of new tools, processes, Quality initiatives, Quality Manual implementation, Manage Technical Complaints, Deviations, CAPAs, Actions, Quality Events and Changes., Contribute to or write trending reports for Technical Complaints for products and processes, Support internal audits of Novartis, audits of third party and HA inspections as required., Support site related compliance and Quality initiatives
• 23-Jul-2013 to 30-Nov-2020 (Production Master Data Manager), 07/23/13, 11/30/20, Creates entire Bill of Materials & Master Recipe for clinical studies and stability studies, including selection of primary packaging material and management of alternative Bill of Materials, Describes the process and answer questions regarding Bill of material / recipe creation/change process during internal/external inspections, Providing necessary supports Tactical planner, SCM, Clinical Trial Supply Managers, Purchasing, Clinical Label Managers, in selecting the most efficient pack- aging design, Coordinating with Tactical planner, Operational Planner and Supply Chain Manager ensuring on time quality check and availability of Bill of materials / master recipes for planning purposes and packaging activities, Meets quantity, Quality, and timelines of all assigned tasks, Maintains packaging material library, Performs QC on Bill of material, Recipe and assigned label (Line Unit review), Ensures that best practice, GMP and SAP requirements are respected for every production version, Liaises with Master Data Management for timely material master data updates., Collects data for KPIs (e.g. RFT), Accountable for quality, Quantity and timelines for all assigned tasks/projects, GMP Compliance (number of deviations, technical issues, audit / inspection findings), Acted as Lead investigator (certified deviation investigator) in number of deviations related to Clinical Operations., Adherence to Novartis standards and Values & Behaviors, in particular, quality, ethical, health, safety, and environment standards (HSE), and information security standards (ISEC)., Unit KPIs (e.g. FPFV (first patient first visit), LTA (lost time accident), FTR (first time right), Rework Rates, Recalls) Cross-functional KPIs (if applicable), Ensure compliance of processes with regulations as well as Novartis internal procedures and GxP requirements., Actively participate in team activities and fulfill all related tasks and responsibilities related to own discipline., Proactively communicate key issues and any critical topic in a timely manner to the appropriate management level and to/or any other relevant project team members. Interpret results, evaluate data, draw conclusions and report back to team and management., Give guidance to team members. Provide coaching and technical training as subject matter expert or recognized technical expert. Act as mentor for junior and senior associates., Actively contribute to team goals., Monitor and report Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken., Execute the activities part of the strategic plan.
• 14th Nov 2008 - 17th Jul-2013 Aurobindo Pharma Limited Assistant Manager, 11/14/08, 07/17/13, Managing Customer Co-ordination with North America & Europe Region., Involving in production planning as per Planning Department and process validation activities related to equipment and processes., Involved in the planning, production, packing and transportation of the products ordered as per the contract with the Client as well as manage appropriate procurement of all API., Designing multi-steps synthesis; conducting research and support activities and developing various products and processes., Responsible for working with the Production team to streamline the manufacturing process based on the forecast as well as Logistics team and freight forwarders for actual shipment, Preparing MIS reports of the Europe and US regions and updating the management in regard to the same., Performing activities with internal and external customers and analyzing sales/manufacturing forecasts on a regular basis.
• Jul 2007 to Oct 2008 Dr. Reddy's Lab. Pvt. Ltd. Senior Executive, 07/01/07, 10/31/08, Handled work allocation for Workmen and Operators as well as conducted training & seminars for them., Coordinated with other department's involved QA, QC, engineering warehouse for smooth functioning at shop floor., Documentation of Production Department, Maintenance of records for Compression & Packing, Machine Preventive Maintenance, Arranging internal Audits & do necessary improvement, Logging & closing incidents on time, Arranging Training & seminars for Workmen and Operators., Carried out the activities of internal Audits, media fill validation, online documentation as per the GMP, manpower handling and logging incidents on time., Implemented activities pertaining to Batch Manufacturing, Looking after Filling as well as Packing, Building Management System.
• Nov 2005 to Jun 2007 Cipla Ltd. Production Officer, 11/01/05, 06/30/07, Involved in Planning, Monitoring, controlling, improving work, Manpower handling, Compression, packing, etc., Prepared documents of Production Department and maintained records for Compression & Packing., Responsible for timely in process checks, maintained safety aspects, machine preventive maintenance, process control without deviations and monitored service floor activities.

• Undergone Oral paper presentation on:
• 55th Indian Pharmaceutical Congress (IPC)held at CHENNAI-2003
• 56th Indian Pharmaceutical Congress (IPC) held at KOLKATTA-2004
• MS-CIT (Passed with 80%).

Love to play Cricket during free time and listen to Old songs.

Would love to go for long drive with family.

Completed German Language (A1 Level) and aimed to complete the next level to get additional language proficiency.