Risk analysis, Resume

TECHNICAL SKILLS

Regulatory: Expertise in Regulatory Standards like GxP, 21 CFR Part 11, 21 CFR Part 210, 211, cGMP, HIPPA, Good Documentation Practice, Good Automated Manufacturing Practice - GAMP 5 and ISO.

Compliance Audit: Experienced in conducting teh Quality Audit for teh software application wif respect to teh guidelines from teh USFDA, ICH, GDP and Internal Quality Systems.

Computer System Validation (V&V): Hands on experience in Verification and Validation of teh computer system starting from preparation of Validation Master Plan, Gap Analysis, Risk Assessment, Mitigation Plan document, Traceability Matrix, IQ & PQ Protocol, Unit and Integration Testing document and Validation Report as per teh classification of GAMP 5, USFDA guidelines and Good Documentation Practice.

Project Management: Experienced in End to End project management starting from Requirement Gathering, Knowledge Transfer, Project Plan Preparation, Identifying teh Deliverables, Project Documentation, Client Communication, Ramping teh Team, Team Building, Team Motivation, Project Execution, and Project Close Out.

Business Analysis: Experienced in Business Requirement Gathering, Requirement Analysis, Preparing User Requirement Specification (URS), Functional Specification (FS), Process Flow Diagram, D Flow Diagram and Business Use Cases for client requirements. Prepared functional specification and use cases for “ePedigree” application development, “eSubmissions” and “SAP Clinical Trial Supply Management”

Process & Facility Validation: Experienced in validation of Pharmaceutical Manufacturing Process, DCS, PLC, SCADA, BMS, HVAC Systems which include preparation of documents like Validation Master Plan, User Requirement, Design Specification, Process & Instrumentation Diagram verification, Master Batch Formulae, Batch Production Record, Validation Report, Deviation Analysis Reports, etc.

Equipment Qualification: Experienced in documenting User Requirement, Design Specification, Site Acceptance Test, Factory Acceptance Test, Preparation and Execution of DQ, IQ, OQ and PQ Protocols and Reports.

Given: Trained more than 200 IT Professionals in regulatory guidelines of 21 CFR Part 11, Drug Life Cycle, & GxP ( GMP, GLP and GCP).

PROFESSIONAL EXPERIENCE

Risk analysis,

Confidential,

Major responsibilities:

Manage Team of 10 Sr. Principal consultants of teh Validation,
Lead and drive teh team to achieve teh required business standards in terms of deliverables, quality, safety, and KPI’s,
Manage all validation related activities, including validation strategy and approval of validation master plans, protocols and reports,
Management of validation related deviations,
Handling Go-to person for day-to-day client communications,
Owning problem-solving leadership and guide multiple project teams,
Use of Quality Risk Management systems to ensure that risks are adequately controlled in accordance wif current requirements,
Identify self-development needs for further performance and teh development needs for teh team,
Understanding clients specific processes and teh business requirements,
Validating teh proposed designs required to complete teh project,
Assisting client during teh Implementation, integration and user acceptance testing phase of teh project,
Preparing for system cutover strategy and creating a cutover plan,
Providing support during teh go-live phase of teh project,
Carry out and Develop Validation package for Confidential products.
Completion of Product Quality reviews,
To lead continuous improvement initiatives for teh group,

Sr. Business Analyst

Confidential

Responsibilities:

Validation & Compliance Specialist for Verification & Validation of Baxter Logix Solution
Business Analyst for SAP Comprehensive Clinical Trial Solution
Business Analyst for ePedigree & eSubmission Solution

Team Lead - Validation & QA,

Confidential,

Responsibilities:

Computer System Validation Documents.
Standard Operating Procedures.
Facility Validation.
Review and Approval of Change Control of Equipment and Process.
Qualification of Equipments - DQ, IQ, OQ & PQ.
Internal GxP audit.
FDA audit preparation and review.

Project Assistant,

Confidential,

Responsibilities:

Preparation & Execution of Validation Protocols
Verification of Process and Instrumentation Diagrams
Gap Analysis & Risk Assessment
Project Planning and Managing teh team
Conducting GMP & GxP Audits
Preparation of Change Control Documents
Qualification of Equipments - DQ, IQ, OQ & PQ
FDA audit preparation and review
Preparing Marketing Presentations and worked in Proposals to Clients

Senior Executive,

Confidential,

Responsibilities:

Preparation of Site Master File
ISO related documents & Standard Operating Procedures
Drafting teh quality documents & Analysis of raw materials, intermediates, and finished products
Conducting quality audits and facility audits

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