SUMMARY:

• I have maintained sufficient experience and knowledge in System Lifecycle, Business Analysis, Project Management, validation quality assurance and regulatory affairs to successfully collaborate, gather and evaluate information, interpret findings, and prepare validation documents.
• Well aware and Proficient in meeting various regulations like the 21 CFR Part 11, GXP s (GMP, GLP, GCP, and GMP), GAMP requirements.
• Understanding of various SDLC Models like Waterfall Model, V Model, Spiral Model, Agile Model etc.
• I am familiar with Laboratory instruments like HPLC, GC, PCR, RT - PCR, UV, KF, other Analytical Instruments and Medical Devices, Techniques related to Equipment / Instrument Validation.
• Hands on experience in the Pharmaceutical industry facilities like Production, Analysis Packaging, Quality Assurance thus possess a good knowledge of maintaining Cleaning Validation policies, guidelines, procedures and approved technical standards.
• Aware of Computer Systems like LIMS, HPQC, QTP, Argus, Trackwise, Sharepoint, Documentum etc.
• Efficiency to undergo risk assessments, Gap Analysis, Deviations, CAPA and creating templates for various deliverables, procedures (SOPS, Work Instructions etc
• Specialist in approving, reviewing and authoring deliverables in all phases of SDLC
• which includes documents like Requirement Specifications ( User Requirement Specifications, Functional Requirement Specifications, Design Specifications,), Validation Plan, Validation Summary Report, Remediation Plan etc
• Good knowledge in generating automated/manual test scripts, working on various test strategies and preparing Test Plans, Test Cases and analyzing test results, Qualification Protocols (IQ,OQ,PQ) as per principles of software validation.
• Superior skill in data collection, tracking, analysis, interpretation, graphical representation and presentation.

Technical Writing Tools: MS Word, MS Excel, MS PowerPoint.

Content Management: Documentum, eRoom, SharePoint, Trackwise, Argus

Testing Tools: Quick Test Professional, HPQC

PROFESSIONAL EXPERIENCE: 

Confidential

Business analyst

Responsibilities:

• Conducted user interviews, gathered requirements, and analyzed the requirements in Clinical research and pre-clinical development phases.
• Conducted JAD sessions with business unit owners, senior research management, and portfolio team to capture business requirements and system behavior.
• Documented test cases during requirements gathering, analysis and design phases.
• Maintained a proactive stance with business relationship(s) to ensure the business needs are always met within GxP Quality guidelines
• Worked on the Business requirement documents, User requirement specifications and functional requirement specifications documents.
• Used tools such as MS-Visio, Excel to define business use cases, activity diagrams, and sequence and state diagrams.
• Participated in full project life cycle, including gathering user requirements, screen and report design, in addition to implementation and roll out.
• Involved with implementation of laboratory and pre-clinical sample management softwares such as Waters NUGENESIS and BioBook to increase efficiency and reduce costs.
• Worked on Mercury tool such as Test Director to ensure that the test scripts are documented, reported and tracked in the Test Director.
• Migrated reports created using Crystal Reports version 9.0 to XI.
• Created SQL queries and views and used those objects to develop reports
• Assisted in Clinical Data Management and Clinical Trials Management.
• Assisted with user testing of systems (UAT), developing and maintaining quality procedures, and ensuring that appropriate documentation is in place
• Created client documentation, acceptance tests plan and user procedures. Served as a tester for systems and user acceptance as per 21 CFR Part 11.
• Facilitated meetings between Tier-3 development and Business owners. Developed Requirements and UAT test scripts for MARS.
• Involved in the preparation and execution of Test Plans, Test Cases, writing Test Scripts using Test Director.

Confidential, VA

Validation Analyst trainee

• Good knowledge of 21 CFR Part 11, CFR Part 58, CFR Part 210, CFR Part 211, GLP, GCP, GMP, GAMP and GDP, Regulatory forms ( 510 K ) and conducting Risk Assessments, Gap Analysis, CAPA etc
• Authored IQ/OQ/PQ and coordinated with System Expert to make sure the system gets qualified.
• Authored Validation Plan, Validation Summary Report and Requirement Traceability Matrix (RTM).
• Reviewed and authored the requirements for calibration and maintenance, developed as draft procedures and finally issued as Standard Operating Procedures (SOPs) / Work Instructions.
• Studied Quality Management systems like Trackwise, HPQC, Quick Test Professional and EDMS systems like Documentum, Sharepoint etc to understand the daily operations of validation group to generate test scripts, deviation forms, change controls, master plans, protocols, and approve them within predetermined timelines.
• Studied immediate solutions for the special situations during implementation of the various system models like Waterfall model, V model, Spiral Model etc.

Confidential

• Developed and supported effective solutions Windows Servers utilizing technologies as .NET and Microsoft SQL Server
• Worked with business teams to gather requirements and to aid in user testing
• Increased productivity and efficiency of comparable property search for property tax reduction clients
• Improved quality of data through development of better geocoding and cleansing of real - estate data
• Saved O'Connor from losing time in sending out legal documents to bad emails accounts
• Saved O'Connor many hours of manual data entry thru automating method of obtaining public data from county Web sites
• Worked to coordinate multiple projects at a time with remote development team in India
• Helped Compaq/HP to increase productivity and ship product directly from the back of the factory

Confidential

Regulatory Affairs

• Represented Analytical QC in CMC project teams, closely interacted various departments including Process Chemistry, Regulatory affairs and Quality Assurance to ensure phase appropriate quality controls needs across multiple programs.
• Timely preparation, compilation and sending of CMC documentation and dossiers for registration of products in various regulated and non - regulated countries like Australia, Honduras, Panama etc.
• Ensuring and Coordinating that the CMC documentation of the product comply with the regulations of the Medicines and Healthcare products and Regulatory Agencies of different countries.
• Maintaining Quality Standards of the product.
• Establishing Decision making Funnels and negotiating with various departments in response to the issues containing any complications.
• Preparing CMC documentation for New Product Licenses and License Renewals.
• Created, formatted and edited multiple Drug Master Files, FDA Product Approval applications, FDA, CVM (Centre of Veterinary Medicine), ICH, GCP, GMP, Regulations and guidelines.
• Managed stability testing, data trending, test methods and specifications for drug substance, drug product, components and raw materials.
• Utilized Documentum based EDMS (Electronic Document Management System) to manage the document work flow.
• Reviewed product promotional materials, packaging, labeling, batch records, specification sheets and test methods for compliance with applicable regulations and policies.
• Lead JAD discussions to solve queries by establishing Decision making Funnels and negotiating with various departments in response to the issues containing any complications.

Confidential / B.E.E Pharmacy

QC Analyst

• Experience in handling sophisticated instrumentation and chromatographic techniques like HPLC, GC, UV, PCR, RT - PCR, KF etc
• Conducted biological, chemical and physical analyses on the raw materials, stability, in- process samples and final products, and samples collected from systems monitoring programs, following controlled test procedures.
• Review of QC data for compliance to procedures and specifications.
• Detailed knowledge of c GMP, GLP and FDA regulations and compendial requirements
• for drugs, biological and biotechnological products, including documentation of activities.
• Analytical method validation and sterility testing of Raw materials, in process and finished products.
• Performed routine and non-routine sample handling, including labeling and packaging for shipment as assigned.
• Prepared standards and samples, calibrated instruments, test samples and reported accurate, on time data, in fast paced environment.