SUMMARY:

• Over 7+ years of extensive experience in pharmaceutical industry with sound knowledge on FDA 21 CFR Part 11, 210, 211, 820, Electronic records, Electronic signatures and Audit Trails.
• Well versed in reviewing and approval of CAPA, laboratory investigations, protocols, forms and instructions to ensure compliance with cGMPs and regulatory filings.
• Experience in process optimization studies including Chemical Process Safety (CPS) and Design of Experiments (DOE).
• Experience writing systems requirements and Verification & Validation (V&V) test cases for medical devices.
• Advanced experience in conducting GAP Analysis and developing Remediation Plans.
• Good knowledge in writing Test Cases, executing and writing Test Summary Reports.
• Experience in conducting walkthroughs, Verification & Validation, system testing, GUI Testing, Unit Testing, Integration Testing, Regression Testing.
• Experience in VHP and Steam sterilization.
• Hands on Clean in Place (CIP), Steam in Place (SIP).
• Experience in Technical Writing, Report Generation and Software Documentation.
• Well versed with the development and maintenance of Requirements Traceability Matrix (RTM).
• Developed manufacturing procedures, document the procedures and provide training for the procedures.
• Hands on P&ID’s and Process Flow Diagrams.
• Experience in performing validation activities for the manufacturing of solid dose, tablet, or small molecule pharmaceutical products.
• Identified, justified, and implemented process improvement opportunities within a regulated manufacturing environment.
• Designed and coordinated the construction manufacturing fixtures.
• Excellent interpersonal, organizational and communicational skills.

TECHNICAL SKILLS

Validation: 21CFR Part11(210, 211, 50, 56, 58, 312, 314), cGXP (GLP, GMP, GCP), Validation, IQs, OQs, PQs, SOP, Remediation Plans, RTM, Gap Analysis, Audit Trails.

Operating System: Windows 95/98/2000/XP/Vista/NT

Testing and Tracking tools: QTP, Mercury Quality Center, Test director, DICOM

Analytical Software: Chemstations, LIMS, AERS

Laboratory Equipment: Spectrophotometer, HPLC, GCMS, Autoclaves, Flow cytometerQuality development skills: FMEA, CIP, SIP, Root Cause Effect Analysis, Commissioning, Swab sampling.

PROFESSIONAL EXPERIENCE

Confidential, NY

Validation Engineer

Responsibilities:

• Determined critical process parameters, equipment specifications, and technical support for development, validation, and manufacturing activities. Worked in the creation of process capability mapping, FMEA exercises and process flow diagrams for all existing products.
• Collaborated with new/existing bulk API manufacturing facilities start - up activities such as GMP reviews, safety and process interlocks definition, new product demonstration, new/existing product technology transfer, instrument classification review, SOP review and Process Description trainings.
• Document Development: Users Requirements, Functional Specifications, Validation Master Plans, Installation Qualification, Operational Qualification, Performance Qualification, Traceability Matrix, Gap Analysis and Summary Reports.
• Provided technical support to manufacturing for the utility and equipment validation of new and existing GMP equipment.
• Utilized Minitab/Excel for basic data analysis and graphs.
• Monitored, sampled and performed testing required for validating pharmaceutical equipment, systems, process and utilities.
• Organized validation projects and ensuring that all equipment and materials are available prior to commencement of projects.
• Well experienced in equipment qualification includes: centrifuges, tanks, compressors, reactors, pumps, heat exchangers, micronization equipment and facilities.

Confidential, NJ

Validation Analyst

Responsibilities:

• Managed the transfer of a lyophilized product from one third party manufacturer to a new manufacturer.
• Managed the validation of a new facility for the aseptic manufacture of a sterile Blow-Fill-Seal product.
• Assisted a manufacture in the design of a validation program for the manufacturer of a Modified Release Capsule.
• Strong knowledge of CAD modeling and drafting practices.
• Conducted an audit of the process development and process validation activities for the manufacture of an aseptically filled biological product.
• Provided Technical guidance for the transfer and scale up of compressed tablet from one facility to another.
• Responsible for formulation design, process development and scale-up of oral solid dosage forms.
• Responsible for hands on laboratory and pilot plant work.
• Trained on Environmental Monitoring such as Particulate Count, Pressure & Temperature differential changes & Sterile Room Release.

Confidential, NJ

Quality Engineer

Responsibilities:

• Generated protocols for various process developments.
• Prepared IQ/OQ/PPQ protocols for different process equipment like media preparation tanks, media hold tank, mixers and centrifuge.
• Developed qualification protocols for column purification processes, formulation tanks and buffer mix/hold tanks.
• Application of QbD, Six Sigma, PAT to decrease validation effort, which includes analysis of data by different statistical tools.
• Implemented Root Cause Analysis (RCA) tools- Fishbone diagram, Repetitive Y-analysis theory and brainstorming to identify the proper root cause of deviations.
• Based on the investigation reports, implemented CAPA (Corrective and Preventive Action) to prevent the future deviations of the same incident.
• Implementation of FDA regulated cGMP quality tools for Pharmaceutical/Biotech industry like Design of Experiment (DOE), Process capability, Gauge RXR linearity study for general cleaning validation.
• Developed the specification range of the parameters like temperature, conductivity, pH, flow rate and pressure to develop the proper cleaning processes.
• Applied and maintained quality standards for process and products in compliance by cGMP.

Confidential

Validation Engineer:

Responsibilities:

• Developed and Executed Equipment Qualification and Validation Protocol(IQ,OQ,PQ, Process Validation Protocol, Validation Reports), cleaning validation protocol by swab sampling method using TOC analyser, Created DOE, Process Development, FMEA, Developed and Validated Spreadsheet.
• Validation of Steam Sterilization of Process Equipment and Piping.
• Validation Plan for UV-Visible Spectrophotometer DU 800 involves validation Master Plan, Validation Protocols, Trace Matrix.
• Chemical API Facilities making Non-sterile products including types of chemical synthesis, Facility Location and Layout, Equipments used, Personnel and Equipment Flow and the areas of the API facility.
• Evaluation and selection of site to build a large scale pharmaceutical manufacturing facility choosing 3 sites.
• User Requirements Specification (URS) for a an Isolator for purchase.
• Blending of Dry Powders for direct compression or dry granulation including Blending Process, types of blenders and functional and operational requirements of V-Blender.
• Thin-Cake Filtration Technology for Removing Activated Carbon, Catalysts, and other Trace Solids from Active Pharmaceutical Ingredient (API) Slurries.