Mar 2016 – Jan 2023 · 6 yrs 10 mos · Faridabad Area, India

• Lead the Quality management system development and implementation
• Create policies, strategies, and processes to support all relevant stakeholders’ services and enable
• business growth while ensuring compliance with regulatory & statutory requirement
• Facilitator for PIP (performance improvement process) an in house portal for registering opportunities for process improvements
• Analyse data from different primary and secondary sources, key industry benchmarks, and emerging
• trends to deliver high quality and actionable business insights
• Development and implementation of Risk management methodology for process improvement
• Quantitative analysis of Quality parameters, monthly and annual trending and providing improvement metrics based on the result
• Plan, Facilitate and perform internal audits, analyse non conformity and best practices and drive performance improvements.
• Engagement of technical reviewers for audit and identifying training gaps wrt. to ISO standards for providing specific learning to auditors
• Facilitating external audit and coordinating with internal team and auditor for smooth process
• Envisaging action plan for CAPA , report feedback on quality ratings and metrics and continuous
• Digitalization -development of quality app

Feb 2015 – Feb 2016 · 1 yr · New Delhi Area, India

• Development and management of quality departments with responsibility for ISO certification for Quality Management System
• Project Validation Management:
• Development and maintenance of quality concepts including GMP, control of project quality systems
• Envisaging and planning of project from conceptual design to detail engineering of facility and equipments , arriving at project costing and project schedule at an optimum limit
• Development and maintenance of quality concepts , control of project quality , development and control of qualification concepts

Aug 2011 – Jan 2015 · 3 yrs 5 mos · Noida Area, India

• Quality Specialist:
• Part of QM board (comprising regions from Europe ,Asia & US) whereby executed quality reviews for global procedures and guidelines along with smooth implementation in India region
• Analyzing of historical data to build quality improvement initiatives and drive quality strategies across the network
• Conducting & leading internal audit for Asia, vendor audits, Compliance & review of reports along with participation with external audit committee for providing responses via CAPA
• Responsible for control of the project quality system (QMS), handling of QMS exceptions and QMS non-conformities, auditing, giving guidance in quality matters to project personnel and securing training of project members
• Management Disciplines
• Development and management of quality departments with responsibility for manning department and daily operations with qualified staff to comply with the Quality Management System - ISO9001, ISO14001 and OHSAS 18001, GAMP5 activities and with authority requirements such as food and drug administration (FDA) and European requirements
• Project Quality Management
• Development and maintenance of quality concepts for control of project quality systems like quality activity plan (QAP), preparation and maintenance, supplier audits and development and control of commissioning and qualification concepts (installation qualification (IQ) and operational qualification (OQ)
• Defining, developing and implementing Risk management plan utilizing quantitative FMECA approach
• Training & Learning
•  Identifying training need, establish global on-boarding plan for new hires and design and develop training materials. Course manager and trainer for programmes on internal online database as “Our Academy”; other e-learning platform like-“Our wiki”, “Our Model
• Has been on GLOBAL QMS Board and authorised trainer for Asia region, collaborating exchange of requirements and systems for global regions (north Europe, Asia, Americas, Russia & France)

Feb 2010 – Jul 2011 · 1 yr 5 mos · New Delhi Area, India

• Regulatory and QA management
• 1) Keeping a track of formulation development, analytical and regulatory activities of product life cycle for facilitation of timely approval and launch.
• 2) To update with the current regulatory guidelines like USFDA,PDA, and ICH regarding improvements/stringency of limits pertaining to microbiology aspects.
• 3) Handling technical queries from Regulatory agencies/Ministry of health via mails / tele-conferencing during and after product registration
• 4) Administration of trainings and report generation, Contribute to the development of standards and guidelines.
• 5) Conduct routine production Audits, provide non conformities and evaluate corrective actions for ISO 9001,14001 & 18001
• 6)Review of artworks and labelling, preparation of text matter for pack inserts, cartons and foils

Jul 2008 – Jan 2010 · 1 yr 6 mos · Derabassi

• 1) Planning & Conducting training for whole company employees (around 500) on various topics- GMP GUIDELINES ; regulatory requirements and SOPs
• 2) Prepare status reports on microbiological failures and keep top management informed of commitments, due dates and progress in the form of weekly reports.
• 3) Co-ordinate & be involved in Regulatory Agency Audits to ensure maintenance of GMP validity of the plants
• 4)Team member in six sigma quality control practice and FMEA analysis