SUMMARY:

• 11 years of combined experience in QARA (Quality Assurance and Regulatory Affairs) with wide exposure to cGMP Practices, Computer System Validations (CSV) and Regulatory Documentation in Healthcare, Medical Device and Pharmaceutical sector.
• Thorough working knowledge on Change control, Incident handling and CAPA (Corrective and Preventive actions).
• Wide exposure to FDA regulated quality control laboratory systems, lab electronic systems validations, manufacturing operations, end to end Drug Serialization implementation and regulatory inspections in cGMP environment.
• Proficient in creating Test Plans, Test Cases based on the Business Requirements and Functional Requirement Specifications.
• Actively involved in Internal Audits and External Supplier Audits.
• Knowledge of industry practices and regulatory expectations as they relate to commissioning, qualification and validation programs.
• Experienced in safety practices in production and laboratory environment.
• Ability to work well independently and as well in a team environment.

PROFESSIONAL EXPERIENCE:

Confidential, Johnson City, Tennessee

Computer Systems Validation Engineer

Responsibilities:

• Serving as an SME for all computer systems validation projects in the organization.
• Implemented cloud - based Quality Management System for Document Control Department.
• Validated Lab Instrument software for Quality Control laboratory.
• Lead role in full cycle validation of Drug Serialization Lines.
• Wide exposure to end to end Serialization Project implementation for Drug Products.
• Conducting periodic Internal Audits and Supplier Audits.
• Responsible for maintaining Validated status for all electronic systems.

Confidential, Miami, Florida

Computer Systems Validation Specialist

Responsibilities:

• Served as Validation Specialist for all computer systems validation projects in the organization.
• Served as a compliance analyst for various clinical trials projects within medical IT.
• Conducted Internal Audits for several research applications departments.
• Handled the responsibility for change control, CAPA and document control activities.
• Analyzing and documenting detailed program information by working and interacting with software developers and members of various other dependent departments.
• Involved in Data Migration End-to-End testing including executing the test procedure and writing the Test Analysis Report for Data Migration End-to-End System Test.

Confidential

Compliance Analyst - Regional Quality Assurance & Regulatory Affairs

Responsibilities:

• Maintained Change Control documentation in accordance with SOPs, Conformance standards and company methodology.
• Prepared deviation logs for the various errors occurred during the testing phase of systems validation.
• Reviewed Traceability Confidential in accordance with requirements and test scripts.
• Handled tracking of country performance on Health Authority submissions and approvals with respect to timelines.
• Supported the department in preparing QA RA Manuals and provided to QA RA personnel across the region.
• Prepared and controlled labeling and packaging components for medical devices.
• Trained as ISO Internal Auditor by an ISO Lead Auditor. Conducted several Internal Audits within the organization.
• Conducted distribution site audits for devices.

Confidential

Sr. Analyst - Quality Assurance

Responsibilities:

• Prepared Annual Product Reviews for all APIs. Participated in sterile and parenteral area in-process plant inspections.
• Involved in the Process Validation in compliance with FDA regulations particularly 21 CFR Part210 & Good Manufacturing Practices (cGMP).
• Wrote Standard Operating Procedures (SOPs) for all aspects of the validation life cycle, in accordance with FDA regulations.
• Conducted assessments of regulated systems to assure validation procedures have been followed in compliance with company policies and predicated rules.
• Involved in Gap Analysis, Risk Analysis and prepared Remediation plans.
• Experienced in handling deviations, change controls and procedural version changes with required .
• Actively participated in Process Validations and Cleaning validations.
• Responsible for follow-up of Regulatory requisitions including DMF deficiencies/regulatory queries.
• Involved in daily monitoring of plant, premises and systems implementation as per cGMP requirements.
• Took charge of vendor evaluation SOP implementation and updating Vendor selection / Evaluation data. Conducted supplier audits.