Summary:

• Computer Systems Validation and Quality Compliance Specialist with over 9 years of
• Experience working in Pharmaceutical and Biotechnology industries with emphasis on
• Software Quality Assurance, Validation and Compliance of computer systems used in
• Pharmacovigilance, Drug Product Manufacturing, Clinical Trials Data Management, Clinical
• Trials Supply Chain, Process Control, and Laboratory Systems HPLC, FTIR and so on
• Provides expertise in FDA 21 CFR Part 11, Part 210, Part 211, Part 820 and GxP regulations
• applied to Computer Systems. Well-versed in providing guidance on performing Gap
• Analysis, Retrospective Validation, Validation Plan, Validation Protocol, Remediation Plan,
• And Standard Operating Procedures SOPs . Excellent understanding of the Software
• Development Lifecycle and Quality Assurance Methodologies.

Technical Skills:

• Validation: 21CFR Part 11, 21CFR Part 210 and 211, 21 CFR Part820 Quality System Regulations , cGxP cGMP, cGCP, cGLP , EMA Annex 11, GAMP 5, MHRA, SOX, ISO 9001
• Testing Tools: Win Runner, Load Runner, Quality Center, QTP Configuration Management Systems Sourceforge and CVS
• Tracking Tools: Test Director, Sourceforge
• RDBMS : Oracle, MS Access, SQL Server
• Languages : C/C , Java

Experience

Confidential

Validation Analyst and Quality Compliance Lead

Responsibilities:

• Worked with Quality, IT and business teams to determine and document the validation approach based on the scope and risk of the project in the Validation Plan.
• Prepared and managed validation lifecycle document i.e. Validation Plan, Requirements Specification, Test Plan, Test Scripts IQ/OQ/PQ , Test Results IQ/OQ/PQ , Test Summary Report, Validation Summary Report and SOPs.
• Developed and documented strategy corresponding to data changes, configuration changes and infrastructure upgrades.
• Completed Risk Profile to determine the applicable regulatory domains e.g. SOX, GxP, Payment Card Industry PCI . Generate regulatory requirements based on applicable regulatory domains.
• Determined and documented 21 CFR Part 11 applicability and document 21 CFR Part 11 requirements in Requirements Specification.
• Developed Part 11 test scripts and documented test results in the test scripts.
• Track compliance deviations in Compliance Regulatory Management System CMRS and provide associated CAPAs.
• Responsible for internal audit and external inspection preparations.
• Attended internal audits and external inspections and provide explanations and documentation to auditors and inspectors.
• Responsible for preparing audit response based on audit findings.
• Responsible for providing guidance on how to test and/or determining procedural controls to meet Information Protection Management Guidelines.
• Responsible for reviewing certain validation documents e.g. Project Plan, Requirements Specification.
• Responsible for document compliance status of computer systems and any gaps from Project Plan in System Specific Compliance Report.
• Responsible for providing guidance on System related SOPs e.g. System Disaster Recovery Plan, Account Management. System Usage, Configuration Management and so on.

Confidential

Computer Systems Validation Engineer

• Prepared Functional Area Validation Master Plans for Non-Sterile Drug Product Manufacturing, Sterile Drug Product Manufacturing, Active Pharmaceuticals Ingredients API , and Materials Management MM functional areas.
• Prepared Validation Plans for different functional areas that define the activities that will need to be completed in order to address the findings identified in the July/August 2003 CQA Audit. Performed necessary steps and closeout findings with respective Validation Reports.
• Responsible for the formalization of the 21 CFR Part11 Remediation process by mapping the entire process and creating necessary deliverables.
• Performed Gap Assessment, created Remediation Plan, prepared protocols IQ, OQ, PQ and documented the Remediation Summary Report for Remediation of Lab instruments.
• Performed the inventory of the systems in Non-Sterile and Sterile Drug Product Manufacturing, Active Pharmaceutical Ingredients API , Parental Device and Development PDD and Packaging and Labeling functional areas. Performed 21 CFR Part11 Applicabilities of around 400 systems in these departments. Performed 21 CFR Part11 Criticalities of the systems identified as Part11 Applicable and remediate the high and medium critical systems as per company SOPs.
• Maintain the Microsoft Access database of GMP systems.
• Develop SOP and other deliverables templates for validation of Spreadsheets
• Participate in the Corporate Computer Systems Audit team for auditing DeltaV and Wonderware Process Control Systems.
• Participated in various business meetings, training for cGMP/ Part11 refresher, DeltaV, SCADA, DOCUEMENTUM, CYBERLAB, BAS, REES and discussed process improvement issues.
• Scheduled meetings, wrote memos and weekly/Quarterly project status reports
• Produced Project plans using MS Project for project planning and management

Confidential

SOFTWARE DEVELOPER

• Requirements gathering from business and customer users, Integration Use Cases documentation
• Design of flows allowing for exchange of invoice and payment data between banks, broker dealers, vendors and Firmview. XML was used for exchanging all sorts of data.
• Design of error queues.
• Used Oracle 9i for backend database on Linux. Resin was used as the Web server.
• Data Exchange Services DES and XMG parser were used.
• Documentation of Database and Build file.
• Secure Sockets Layer SSL protocol was used for security.
• Accion, Inc. Non-profit loan providers. Integration of web-based application to EDS CUBE servers. Exchange of XML messages was according to OLI SPECIFICATION. dlls were installed provided by OLI.
• Requirements gathering, Integration Use Cases documentation.
• Design of flows allowing for exchange of different types of loans among different Cube servers. XML was used for exchanging all sorts of data.
• SQL Server was used for backend database. Resin was used as the Web server.
• Testing was performed with different EDS Cube servers.