Jabin Khan
Pune
Summary
- Over 7+ years of experience in Pharmaceutical, Manufacturing, Biotech, Drug and Device Manufacturing industry with Software Development Life Cycle, Software Implementation Life Cycle, Change Control Management and implementation of business application.
- Has gained expertise in all the phases of software and computer system validation according to 21 CFR Part 11 and GxP FDA Regulations.
Have working knowledge of GLP, GCP, GAMP V, cGMP, ICH, ISPE guidelines especially in the areas of computer or related systems. - Good experience in authoring and reviewing of Validation Plan, Risk Assessment, Specifications (FRS,URS, DS, CS), Validation Protocols IQ/OQ/PQ/DMQ/DRQ, Validation Summary Report, SOP’s, Protocol Deviation Report, Decommission Report, Periodic Review Report.
- Experienced in validating Cots, SaaS and Custom developed application.
- Have knowledge in key pharma application like Track wise, Documentum and Argus Safety.
- Experienced in working with Test Management Tool like HP ALM.
- Excellent Knowledge and experience in Good Documentation Practices.
- Working knowledge in key pharmaceutical areas like regulatory and R&D information systems, pharmacovigilance, Manufacturing and Safety signal detection systems.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Sr. Computer System Validation Specialist
Tata Consultancy Services Ltd
09.2017 - Current
- Developed computer system validation related content, controlled documents to support the start-up, validation, operation and maintenance of site GMP computerized system for project qualification plans and protocols.
- Authored, reviewed and approved the validation plans, computer validation protocols and reports.
- Involved GAP analysis, Root Cause Analysis, Corrective and Preventive Actions (CAPA) reporting, handling and closing of identified defects and findings.
- Ensured the system are compliant with current corporate computerized validation polices and legislative requirements.
- Ensured all tools, templates and materials are readily available and up to date.
- Support change management activities for cGMP computer systems (ERP, EDMS, LMS, VLMS) and other related activities.
- Supported regulatory inspection and internal and partner and implemented corrective actions as needed.
- Provided computer system validation related response to inspectors/auditors.
- Launched a comprehensive Process Validation venture, resulting in a 60% reduction in production time.
- Developed and maintained rigorous SOP and GAMP methodologies.
Managed a cross-functional team, achieving a 35% increase in efficiency. - Implemented advanced Laboratory Information Management System (LIMS), improving laboratory data management by 50% and ensuring compliance with GLP standards.
- Executed Corrective and Preventive Actions (CAPA) protocols, enhancing compliant resolution speed by 40%.
Conducted extensive CSV using U.S. Title 21 CFR Part 11 Regulations. - Manual testing for DEV, Q and Prod system.
Customer Care Executive
Aegis Pvt Ltd
04.2017 - 09.2017
- Evaluated interactions between associates and customers to assess personnel performance.
- Coordinated timely responses to online customer communication and researched complex issues.
- Provided excellent customer service by efficiently resolving issues and responding to inquiries.
- Assigned and designated job territories to customer care staff according to performance and history.
- Resolved concerns with products or services to help with retention and drive sales.
- Took ownership of customers issues to follow problems through to resolution.
- Developed and implemented customer care policies, procedures and regulations necessary to satisfy customer base.
- Conducted surveys to determine customer opinion of products and services.
- Kept accurate records of all customer interactions and transactions.
- Collected customer information and analyzed customer needs to recommend potential products or services.
- Provided customers with updates and periodic statements on service developments and changes in trends.
- Oversaw hiring, orienting and training of customer care staff to facilitate capable workforce.
- Communicated with customers to identify needs and expectations.
Medical Underwriter
EXL Customer Solution Pvt. Ltd
06.2014 - 05.2015
- Studied insurance industry changes, remaining up-to-date with latest trends and protocols.
- Utilized knowledge of insurance principles, policies and procedures to make decisions on risk assessment.
- Proven ability to learn quickly and adapt to new situations.
- Developed and implemented underwriting policies and procedures, establishing useful and accurate processing of applications.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
- Demonstrated leadership skills in managing projects from concept to completion.
- Monitored underwriting teams' performance and provided mentoring to achieve personal and department production goals.
Customer Service Executive
Vertex Customer Solution Pvt. Ltd.
09.2012 - 04.2014
- Resolved customer billing errors by researching issues in system, asking open-ended questions, and determining root causes of problems.
- Described product and service details to customers to provide information on benefits and advantages.
- Escalated critical customer issues to supervisor immediately to avoid lost revenue and canceled policies.
- Employed comprehensive benchmarks to establish and monitor customer service standards.
- Provided company information and policies to customers upon inquiry and answered questions via phone, email, or online chat.
- Developed working relationships with internal and external customers while assisting with account management duties.
- Informed customers of upcoming promotions and deals to boost sales.
Education
Bachelor of Technology - Biotechnology
Anna University
Chennai - India05.2011
Skills
- Computer System Validation
- GAMP
- Change Control
- Good Manufacturing Practice (GMP)
- Process Validation
- US Food and Drug Administration (FDA) Validation
- Quality System
- Verification and Validation (V&V)
- Software Development Lifecycle (SDLC)
- Software Implementation Lifecycle (SILC)
Certification
- Pharmacovigilance_E0_iON
- Cloud Computing_FP(57965)
- Life Sciences : ICH-GCP
- Manual Testing
Languages
English
Full Professional
Marathi
Advanced (C1)
Hindi
Professional Working
Additional Information
Industry Regulations: 21 CFR Part 11, Annex 11, 21 CFR 807, 21 CFR Part 814, 21 CFR Part 812, 21 CFR Part 820, 21 CFR Part 814, 21 CFR Part 801, 21 CFR Part 803, ASTM E2500, ICH, ISPE
Timeline
Sr. Computer System Validation Specialist
Tata Consultancy Services Ltd
09.2017 - Current
Customer Care Executive
Aegis Pvt Ltd
04.2017 - 09.2017
Medical Underwriter
EXL Customer Solution Pvt. Ltd
06.2014 - 05.2015
Customer Service Executive
Vertex Customer Solution Pvt. Ltd.
09.2012 - 04.2014
Bachelor of Technology - Biotechnology
Anna University
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