SUMMARY

• Achievement - oriented quality assurance engineer with more TEMPthan 20 years of affiliation in teh pharmaceutical environment implementing teh requirements of regulatory requirements such as cGMP’s, GCP, GLP, CFR Part II, GAMP5, SOX, HIPPA, Data Privacy, Electronic Signatures/Records and SDLC. Skilled in reviewing, approving, auditing and implementing policies, procedures, work instructions, validation, spreadsheet validation and validation deliverables for Computer Systems, Laboratory Systems, Packaging and Manufacturing Systems. Project lead in teh assessment of laboratory and manufacturing equipment
• Knowledgeable of Quality Systems such as Change Control Process, Corrective and Preventive Action (CAPA), Document Control Process, Quality Agreement, Complaint Handling Process, Investigations, Annual Product Review, Non-Conformance Report and Deviation, Validation.Knowledgeable of automated validation tool- HPALM (Application Lifecycle Management)
• Review laboratory data and deposition raw material, finished product for release against established specification, Review Manufacturing Batch Records, Packaging Records and Stability Records
• Reviewed and approved validation documents in alignment with regulatory requirements such as, cGMP’s, GCP, GLP, CFR Part II, GAMP5 requirements and company standards.
• Review and approve Validation Deliverables (Compliance Assessment, Compliance Plan, Validation Plan, Risk Assessment, User/Functional Requirement Specification, Traceability Matrix Qualification Protocols/Test Scripts (Pre/Post Executed, IQ, System Test, UAT, Production), Test Defects (Deviation), Change Management /Control, Summary Report, Release to Production (Use) Memo, CSV Systems such as TrackWise Quality Management System, LabWare LIMS, Electronic Laboratory Notebook, Chromatography Data Systems and Electronic Document Management System, Manufacturing and Packaging Systems and processes and Laboratory equipment and processes
• Review procedures (SOP’s, etc.) for quality and compliance issues
• Review and approve pre-and post-executed Equipment Protocols for Analytical and Microbiological systems
• Review and approve pre-and post-executed documentation for Computer Systems, Manufacturing Systems, Laboratory Systems
• Packaging, Labeling and Warehousing Systems (which include Packaging Vision Systems, Serialization Solutions Environmental Monitoring Buildings}
• Validated high speed packaging line (unscramble cartooned, inserter, shrink wrapper, automatic check weigher0
• Requalification of powder filling line, Evaluate and approve Change Control Request for qualified systems
• Review of executed manufacturing batch records for compliance of manufacturing processes/steps, ensuring dat all applicable documents, records and forms are completed and attached
• Prepared Annual Product Review Reports, Manufacturing Investigation of failure Reports, Periodic Review Reports
• Approval and release of reviewed executed batch records, as appropriate
• Development of controlled documents and procedures pertinent to Manufacturing and Quality Assurance (QA) activities and functions, as well as other procedures if deemed necessary
• Periodic monitoring and verification of operations to ensure compliance to written procedures and/or regulatory requirements
• Creation, issuance, tracking, review, approval and/or control of labeling materials
• Provide training, as needed, and keeps track of individual training needs, including follow-up with department heads or supervisors
• Conducts GMP, GLP, or GCP audits (internal and external), as applicable
• Provide Compliance guidance on qualification and validation activities

PROFESSIONAL EXPERIENCE

Confidential, Morris Plains, NJ

Computer System Validation Quality Assurance

Responsibilities:

• ClinApps SmartSupplies Suite application release: 5.4.0
• FUSION LIMS V6 Upgrade
• Enhanced Visual Reporting Spotfire Tool (EVIREST)
• Chemical Management System (CMS)
• Consumer Approval for Product Release Integration (Capri)
• ArteWork and Labeling Management System (COCOON)
• NA Consumer Response System (CRS)
• Remetrex Safety System/Device Malfunction System-Data Hub Integration
• Reviewed teh following documents: Compliance Analysis, Compliance Plan, User Requirement Specification, Functional Requirement Specification, Technical Design Specification, Master Test Plan, System Test protocol, User Acceptance Protocol, Pre- and Post-Executed System Test Scripts, Pre- and Post-Executed User Acceptance Test Script, System and UAT Test reports and Compliance Reports
• Review and Approve Validation documents in alignment with regulatory requirements such as, cGMP’s, GCP, GLP, CFR Part II, GAMP5 requirements and company standards which include Change Control and Operational Qualification Documents, related to teh Analytical Research Laboratory, Pharmaceutical Research Development Equipment, Processes, and Utilities
• Review Work Instructions, Standard Operating Procedures, related to teh Analytical Research Laboratory, Pharmaceutical Research Development Equipment, Processes, and Utilities
• Review Investigations and Quality Events related laboratory excursions related to qualification, calibration, performance verification and preventive maintenance.
• Review Periodic Review and Revalidation Reports of Qualified Systems

Confidential, New Brunswick, NJ

Pharmaceutical Validation/Quality Assurance Engineer

Responsibilities:

• Coordinated teh compliance activities for teh relocation teh laboratory operation, instrumentation and equipment of 3 Major Laboratories
• Quality Oversight for Analytical Research Development (ARD) at teh New Brunswick site
• Quality Oversight for Bioanalytical Sciences (BAS) at teh Hopewell site
• Quality Oversight for Clinical Supply Operations (CSO) Packaging, Labeling and Logistics at teh New Brunswick site
• Reviewed and approved validation documents in alignment with regulatory requirements such as, cGMP’s, GCP, GLP, CFR Part II, GAMP5 requirements and company standards, related to teh Analytical Research Laboratory, Bioanalytical Sciences, Pharmaceutical Research Development Equipment, Processes, and Utilities
• Reviewing Work Instructions, Standard Operating Procedures, related to teh Analytical Research Laboratory, Bioanalytical Sciences, Pharmaceutical Research Development Equipment, Processes, and Utilities
• Quality Oversight for teh relocation of teh microbiological and teh life cycle development laboratories
• Quality Oversight for Buildings 25 and 109 Containment Weigh Suites
• Preparing Compliance impact assessments
• Review Investigations and Quality Events related laboratory excursions related to qualification, calibration, performance verification and preventive maintenance
• Reviewing Installation/Operational Qualification Documents, Validation Deliverables, and SOP’s in alignment with regulatory
• Requirements such as, cGMP’s, GCP, GLP, CFR Part II, GAMP5 requirements and company standards .
• Preparing Compliance assessments and Gap Analysis
• Developing operational qualification test plan and test scripts for teh upgrade of Documentum Application
• Verifying application test cases in sandbox and QA environments.
• Writing operational qualification test scripts in Mercury Quality Center
• Reviewing operational qualification test scripts for teh upgrade of Documentum Application
• Prepare and review annual productreview documents
• Performed Quality Systems Assessment
• Performed computer systems related validation and quality activities.
• Reviewed laboratory data and QA data
• Write and reviewed test scripts for QMS Documentum

Confidential, Pearl River, NY

Pharmaceutical Validation/Quality Assurance Engineer

Responsibilities:

• Performed Quality Systems Assessment
• Performed computer systems related validation and quality activities in alignment with regulatory requirements such as, cGMP’s, GCP, GLP, CFR Part II, GAMP5 requirements and company standards
• Project Leader for qualification of Applications such as Changman ZMF, Xform, and Xptr. Authored teh SDLC deliverables, Migration document. Witness teh execution of IQOQ. Authored teh summary report
• Audited qualification documents for compliance. Review executed installation and operational documentation for infrastructure servers.
• Investigated Manufacturing Failures and addressed quality and validation issues, Investigated Laboratory Failures (OOS)
• Reviewed Validation Protocols (Process, Equipment, Product, Computerized Quality System) and Prepare Summary Report
• Reviewed Change Control, Corrective and Preventive Actions (CAPA) documents
• Reviewed analytical data generated by methodologies dat included High Pressure Liquid Chromatography (HPLC), Atomic Adsorption (AA), Gas Chromatography (GC), UV/VIS Spectrophotometry, Infrared Spectrophotometry (IR), Moisture Analyzer
• Developed, executed and summarized validation studies for manufacturing processes, automated computer systems and equipment
• Audited Computer System Validation Deliverables, SOP, WI for compliance against regulatory and company standards
• Reviewed Validation Deliverables (SDS, URS/FRS, Validation Strategy Documents, IQ/OQ, PQ/UAT, Traceability Matrix, and Validation Report) in alignment with regulatory requirements such as, cGMP’s, GCP, GLP, CFR Part II, GAMP5 requirements and company standards.

Confidential

Validation Specialist

Responsibilities:

• Reviewed Change Control, Corrective and Preventive Actions (CAPA) documents
• Prepare Annual Product Review for trade products
• Reviewed Standard Operating Procedures
• Executed and summarized validation studies for manufacturing processes, automated computer systems and equipment
• Developed, executed and summarized validation studies for processes, automated computer systems and equipment
• Reviewed and approved Validation Protocols (Process, Equipment, Product, Computerized Quality System) and Prepared Summary Report
• Reviewed analytical data generated by methodologies dat include High Pressure Liquid Chromatography (HPLC), Atomic Adsorption (AA), Gas Chromatography (GC), Automated Computerized Systems, UV/VIS Spectrophotometry, Infrared Spectrophotometry (IR), Moisture Analyzer
• Developed and implemented Validation Plans, Generated Installation / Operational Qualification (IQ/OQ), Performance Qualification (PQ) and Cleaning Validation protocols and summary reports for manufacturing/packaging processes, equipment (automated and non-computerized), systems, facilities and utilities in alignment with regulatory requirements such as, cGMP’s, GCP, GLP, CFR Part II, GAMP5 requirements and company standards
• Re-validated a powder fill weight process utilizing historical production data and statistical analysis
• Performed vendor audits for GMP compliance and validation issues
• Authored departmental Standard Operating Procedures (SOPs) and maintained teh department’s SOP database

Confidential, ELMWOOD, NJ

Quality Control and Assurance Manager

Responsibilities:

• Responsible for day-to-day QA/QC functions to include: monitoring of manufacturing operations, reviews of batch records, customer complaints, products, specifications and drug product labeling; GMP training, and assured compliance to OSHA Hazardous and Federal Regulations
• Reviewed and disposition analytical data generated by methodologies dat include High Pressure Liquid Chromatography (HPLC), Atomic Adsorption (AA), Gas Chromatography (GC), Automated Computerized Systems, UV/VIS Spectrophotometry, Infrared Spectrophotometry (IR), Moisture Analyzer
• Monitored manufacturing operation for teh products’ physical and chemical attributes