Karishma Patil
Documentation Executive
Mumbai
Summary
Detail-oriented Documentation Specialist with expertise in preparing and reviewing FAT, SAT, DQ, IQ, OQ, and PQ protocols. Skilled in developing validation master plans, SOPs, and compliance documentation while collaborating with cross-functional teams to enhance qualification processes. Committed to maintaining accurate records and supporting audits to uphold regulatory standards.
Overview
3
3
Languages
6
6
years of professional experience
Work History
Documentation Specialist
Lifecraft Engineering (India) Private Limited
Dombivali
02.2026 - Current
- Preparation and review of FAT, SAT, DQ, IQ, OQ, and PQ protocols and reports.
- Development and control of validation master plans (VMP), SOPs, and qualification documentation.
- Documentation support for equipment qualification, utility qualification, and process validation activities.
- Coordination with Engineering, QA, QC, Production, and Validation teams for qualification projects.
- Ensuring compliance with GMP, GDP, ALCOA+, and regulatory guidelines.
- Managing document lifecycle activities including issuance, revision, approval, and archival.
- Supporting audits and inspections by maintaining complete and accurate validation records.
- Preparation of risk assessments, traceability matrices, deviation reports, CAPA documentation, and change control records.
- Ensuring data integrity and documentation compliance throughout project execution
Documentation Executive
Khator Technical Textiles Ltd.
05.2025 - 02.2026
- Prepared and managed export and domestic shipment documentation, including invoices, packing lists, certificates, and shipping documents.
- Coordinated with production, merchandising, logistics, and freight forwarding teams to ensure timely dispatch of orders.
- Maintained accurate records of customer orders, shipment details, and compliance documentation.
- Verified documentation accuracy and compliance with company policies and international trade regulations.
- Assisted in customs clearance and export procedures by preparing required documents.
- Managed document filing, tracking, and retrieval systems to ensure easy access and record maintenance.
- Collaborated with clients and vendors to resolve documentation-related issues and ensure smooth operations.
- Generated reports and maintained databases related to shipments, orders, and documentation activities.
Documentation Officer
Skypack Technology
02.2025 - 05.2025
- Managed and controlled pharmaceutical documents, ensuring compliance with GMP and company procedures.
- Prepared, reviewed, issued, archived, and tracked SOPs, protocols, reports, and quality records.
- Maintained document control systems and ensured timely document revisions.
- Supported QA, QC, Production, and Regulatory Affairs teams with accurate documentation.
- Coordinated document review workflows and ensured compliance with regulatory requirements.
Database Administrator
Cloudstrats
07.2021 - 12.2023
- Database Administrator with expertise in database management, SQL, backup and recovery, performance optimization, and data security.
- Experienced in maintaining database reliability, troubleshooting issues, and ensuring seamless access to critical business data.
- Dedicated to delivering efficient, secure, and scalable database solutions.
- Database Administrator | SQL | Database Management | Performance Tuning DBA | MySQL | Oracle | SQL Server | Backup & Recovery
- Database Administrator | Data Security | Database Optimization | System Support
- SQL Database Administrator | Data Management | Troubleshooting | Analytics
System Administrator
ICICI Prudential Life Insurance Company Limited
06.2020 - 11.2020
- Handled accounts and access requests for various software to ensure authorized access.
- They maintain file system security, data integrity, and passwords.
- Being able to set up and maintain Local Area Networks (LAN) and Wide Area Networks (WAN), in addition to setting up network security features like firewalls, is often expected of system administrators.
- This might often be the case at smaller companies, where IT professionals are expected to wear many hats.
Education
High School Diploma -
04.2001 -
Skills
Document control
SOP preparation
Documentation management
Protocol preparation
Timeline
Documentation Specialist - Lifecraft Engineering (India) Private Limited
02.2026 - Current
Documentation Executive - Khator Technical Textiles Ltd.
05.2025 - 02.2026
Documentation Officer - Skypack Technology
02.2025 - 05.2025
Database Administrator - Cloudstrats
07.2021 - 12.2023
System Administrator - ICICI Prudential Life Insurance Company Limited
06.2020 - 11.2020
Terna Engineering - High School Diploma,
04.2001 -