Oct 2025 – Feb 2026 · 4 mos · Hybrid

Feb 2024 – Oct 2025 · 1 yr 8 mos · Hybrid

• Develop and execute validation plans for computerized systems to ensure they meet the requirements of regulatory bodies such as the FDA, EMA, and other applicable guidelines.
• Collaborate with IT and quality assurance teams to define and document system requirements and specifications for both new and existing systems.
• Design and perform qualification tests, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to verify that systems are installed and operating according to their intended use.
• Conduct risk assessments to identify potential risks associated with computerized systems and implement mitigation strategies to address these risks.
• Prepare and maintain validation documentation, including validation protocols, test scripts, and validation reports, ensuring traceability and compliance with Good Documentation Practices (GDP).
• Stay current with industry trends and regulatory updates related to computer system validation to ensure ongoing compliance and best practices.
• Work with cross-functional teams to troubleshoot and resolve any issues arising during the validation process or routine use of the systems.
• Facilitate change control processes for computerized systems, ensuring that any changes are appropriately validated and documented.

May 2022 – Feb 2024 · 1 yr 9 mos · Verna, Goa, India · On-site

• Develop and execute validation plans, test plans, test scripts, and traceability matrices for computerized systems to ensure they meet all required specifications and regulatory standards.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and operational departments, to define and document system requirements and specifications.
• Perform risk assessments to identify potential risks associated with the computer systems and implement appropriate risk mitigation strategies.
• Conduct validation activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing systems.
• Ensure that all aspects of the computer system lifecycle, from design and development to decommissioning, are in compliance with validation protocols and standard operating procedures (SOPs).
• Review and approve validation documentation, including validation protocols, test cases, deviation reports, and final validation reports.
• Provide training and support to system users on validation processes and SOPs to ensure ongoing compliance and proper system use.
• Maintain up-to-date knowledge of industry regulations and best practices related to computer system validation and data integrity.
• Lead continuous improvement efforts in the validation process to enhance efficiency, effectiveness, and compliance.
• Act as a liaison between the company and regulatory authorities during audits and inspections, addressing any CSV-related inquiries and findings.

Dec 2020 – May 2022 · 1 yr 5 mos · Dadra and Nagar Haveli, India · On-site

• Overseeing the validation of manufacturing processes, equipment, and cleaning procedures to ensure compliance with FDA regulations and industry standards.
• Developing and executing validation plans, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Collaborating with Quality Assurance (QA) and Quality Control (QC) teams to establish protocols and standard operating procedures (SOPs) for production and validation.
• Leading cross-functional teams to identify and mitigate risks, ensuring the robustness and reliability of manufacturing processes.
• Reviewing and analyzing validation test data to confirm that systems and processes operate as intended and meet regulatory requirements.
• Training production staff on validation concepts, procedures, and GMP to maintain a culture of quality and compliance.
• Managing the change control process for production equipment and processes, ensuring that all changes are assessed, validated, and documented properly.
• Conducting routine revalidation activities to ensure continuous compliance and performance of manufacturing systems.
• Investigating any deviations or non-conformances in the production process and implementing corrective and preventive actions (CAPAs).

Oct 2019 – Nov 2020 · 1 yr 1 mo · Vapi, Gujarat, India · On-site

• Develop strong leadership and management skills to effectively lead a team of production personnel.
• In-depth knowledge of pharmaceutical manufacturing processes and equipment.
• Familiarity with regulatory requirements and quality standards specific to the pharmaceutical industry.
• Excellent problem-solving abilities to quickly address and resolve production issues.
• Effective communication skills to interact with team members, management, and cross-functional departments.
• Attention to detail and a commitment to maintaining high-quality standards.
• Ability to work under pressure and adapt to changing production demands.
• Proficiency in production planning and inventory management.

May 2018 – Jun 2018 · 1 mo · Rajarhat, kolkata · On-site

• Gained hands-on experience with pharmaceutical manufacturing technologies and processes.
• Developed a strong understanding of industry regulations and the importance of compliance in pharmaceutical production.
• Enhanced problem-solving skills through troubleshooting production issues and participating in process optimization.
• Strengthened communication and teamwork abilities by working closely with professionals from various departments.
• Improved attention to detail through meticulous record-keeping and quality control practices.