Professional Summary

• Over six 6 years of experience in FDA-regulated Pharmaceutical, Biotech, and Medical device Industry.
• Excellent knowledge of FDA regulations, cGxP protocols cGMP, cGCP, cGLP , GAMP5 and 21 CFR Part 11, 210, 211, 820 and associated FDA regulations.
• Experienced in reviewing, modifying and re-writing Validation Strategy Document VSD , Validation Master Plan VMP , Standard operating procedures SOPs and Validation Protocols IQ, OQ and PQ documentation.
• In-depth knowledge of Process and Cleaning Validation of solid Dosage, equipment qualification, water system, CIP/SIP, Equipment Change Control, Deviations and CAPA.
• Experienced in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries.
• Proficient in reviewing all SDLC documents, protocols and SOP's to ensure they meet FDA regulations.
• Experienced in Developing and reviewing User Requirements Specifications URS , and Functional Requirements Specifications FRS and Requirements Traceability Matrix RTM documents.
• Well-experienced in Risk Assessment, Gap Analysis and documenting Remediation Plan.
• Enthusiastic and motivated communicator with excellent interpersonal and communication skills both written and oral .
• Quick learner, having effective time management skills and the ability to manage multiple projects and re-prioritize as necessary.

Technical Skills:

Operating Systems: Windows 2000, Windows 7, Windows 8, XP, Vista, Mac OS

Tools: HPQC, Minitab, MS Visio, MS Office, MS SharePoint, Adobe Illustrator CS5.1, Adobe Photoshop CS5.1

Validation: FAT, SAT, SOP, VMP, IQ, OQ, PQ, VSR, URS, SRS, SDS, RTM, FMEA

Regulatory: 21 CFR part 11, 210, 211, QSR 820, Annex 11, OSHA, EPA

Environment: LIMS, TRACKWISE, Clinical Trial

Scientific Skills: DNA extraction, RNA extraction, Gene Editing, PCR, Gene Cloning, In situ hybridization, Electrophoresis, Microscopy, Research Data Analysis, Science Communications technical writing and public speaking .

Project Experience

Confidential

Validation Scientist

Project: Commissioning, qualification and cleaning validation of Solid dosage pharmaceutical drug manufacturing equipment.

Responsibilities:

• Involved in commissioning, qualification and cleaning validation of Solid dosage pharmaceutical drug manufacturing equipment.
• Developed and implemented Cleaning Validation Master Plan VMP .
• Developed and executed cleaning validation protocols for manufacturing and process equipment like Rotary Mills, Bin Blenders, Tablet Presses, Filling Machine and Tablet Film Coaters.
• Identified appropriate cleaning methods/agents and developed acceptance criteria for residuals and degree of evaluation required to validate the process.
• Performed swab/rinse sampling for active ingredients detergents.
• Drafted and executed Cleaning-In-Place CIP verifications.
• Prepared and executed in execution of validation protocols IQs and OQs for process equipment to assure equipment is properly installed and operating as specified and designed.
• Prepared and maintained SOPs and the logbooks with accuracy.
• Investigated deviations and take corrective action to resolve the deviations
• Maintained and updated Requirement Traceability Matrix RTM to track requirements that correlated with the conducted tests.
• Generated final Validation Summary Report VSR to summarize testing results and conclusion.

Confidential

Validation Specialist

Responsibilities:

• Reviewed the Business Requirements Document and created Design Document.
• Worked as a team member of the Qualification Team, supporting the development and approval of validation deliverables and protocols.
• Responsible for preparing, reviewing and executing Commissioning documents, IQ/OQ's for equipment validation protocols.
• Assisted in development and approval of the equipment qualification Plan.
• Supported biotechnological process environment including writing IQ/OQ protocols, reports and assessments for a start up process facilities.
• Performed Document Review on executed Validation Protocols for GDP and Compliance.
• Developed and executed the validation protocols for GC Gas Chromatography and HPLC High Performance Liquid Chromatography .
• Maintained and updated Requirement Traceability Matrix RTM to track requirements that correlated with the conducted tests.
• Executed GAP Analysis and also developed the corresponding Remediation Plan.
• Contributed towards development of Validation Summary Report VSR

Confidential

Validation Analyst

Responsibilities:

• Performed GAP analysis and prepared Remediation Plans to fix the gaps identified in existing packaging validation.
• Planned and executed packaging validation and equipment qualification activities.
• Performed packaging equipment qualifications including IQ, OQ, PQ for existing and new products.
• Followed Standard Operating Procedures SOP for packaging equipment.
• Worked closely with suppliers and other engineers about packaging problems, identified root cause and took corrective action CAPA .
• Provided support to packaging validation activities, continuous improvement initiatives, operational readiness of packaging and the resolution of packaging business interruptions.
• Involved in Process validation phase to ensure that established limits of critical process parameters are valid.
• Reviewed and monitored batch records for packaging to ensure accuracy and compliance with QA specifications and GxP regulations.
• Generated and instrumental for the approval of final Validation Summary Report VSR .

Confidential

Validation Specialist

Responsibilities:

• Analyzed User and Functional Requirements.
• Authored Validation Master Plan and GxP GLP, GCP, GMP, c GMP FDA Assessment.
• Developed and instrumental in the approval of URS and FRS for microscope and Bioanalyzer instruments system.
• Co-ordinated with the vendors in commissioning of the instruments, system suitability tests, and resolving technical issues.
• Assisted in risk analysis of the requirements with the team.
• Developed and executed IQ, OQ and PQ protocols.
• Involved in server qualifications both application and the database servers.
• Initiated enhanced SOPs to help the business process in line with FDA regulations.
• Verified Audit Trails, logical security and user privileges.
• Developed deliverables during different phases of computer systems validation lifecycle SDLC .

Confidential

Validation Specialist

Responsibilities:

• Completed a prototype with Sample Manager Labware LIMS to demonstrate appropriate workflow functionality.
• Reviewed Master Validation Plan document and prepared Test Plan, User Requirements
• Specifications, Functional Requirements Specifications and Design Specifications.
• Completed and developed regulatory and business requirements updates.
• Developed Requirements Traceability Matrix.
• Acted as a liaison between the Management Team and the Information Systems Group.
• Drafted and reviewed Standard Operating Procedures SOP .
• Completed and submitted weekly status to the QA manager.
• Wrote Validation IQ, OQ, PQ protocols for the LIMS software.
• Used HPQC for test case generation, execution and follow up of the defects till closure.
• Assisted in creating Test scripts to check the Installation and Operational Qualification IQ/OQ for the application.
• Attended weekly review meetings to discuss open defects and its resolution.
• Handled the project documentation as per the Quality Assurance plan.
• Coordinated with systems personnel in order to complete the development of business projects including the Cost Benefit Analysis