OBJECTIVE

• Seeking a Quality Management position where I can apply my 25 years of experience in Pharmaceuticals.
• Looking to help a company enhance their Quality Systems and in addition help improve and develop elements of teh Quality Systems that are needed.

SUMMARY

• Lead Quality Auditor wif 25 years of experience wif GXP regulations (GMP, GLP & GCP) for clinical and commercial manufacturing. Emphasis in Solid Dose, API, Consumer Healthcare, Liquid Suspension, Vaccines, Aseptic, Fermentation and Purification processes and Injectibles. As well as 10 years of experience auditing Medical Device operations and 4 years wif In Vitro Diagnostics.
• Direct Experience wif FDA and EMEA, ISO Certification, Consent Decrees, Recalls, FDA Field Alerts, writing 483 Responses and reviewing documents for IND, NDA, and 510K submissions.
• Extensive knowledge of CFR 210/211, 21 CFR Part 820 (Quality System Regulation), ISO 13485:2012, Canadian Medical Device Regulations (SOR/98 - 282) and teh IVD Directive (98/79/EC). ICH E6 Good Clinical Practice Consolidate Guidance. As well as ISO Standards: 9001, 14971:2012 and ISO/IEC 17025.
• Experience wif EU Regulations. Directive 2001/83/EC and Regulation (EC) No 726/2001. As well as Regulations (EC) 141/2001 (Orphan Medicines), (EC) No 1901/2006 (Medicinal products for children) and (EC) No 1394/2007 (Advanced therapy medicinal products)
• Experience wif WHO guidance for pharmaceuticals.
• Authored and edited procedures according to 21 CFR Part 11. Assisted in software validations. Reviewed and approved software validations. Ensured compliance through auditing systems and trending data.
• Development & Management of QA Systems including but not limited to; Training, CAPA, Deviations, Non Conformance, Internal/External Audit Programs, Recall Systems, and Complaints. Assisted wif teh management of Environmental controls, auditing data, reviewing data trends, investigating excursions along wif authoring and revising procedures.
• Experience in building CAPA systems. Included developing SOPs, utilizing Root Cause Analysis utilizing teh following techniques- Fishbone diagrams, 5-Why's, Ishikawa, and FMEA.
• Expert level experience wif Internal and External Auditing, managing regulatory audits and customer audits.
• Excellent computer skills - MS Office, Word, Excel, PowerPoint, Access, Project, SAP, LIMS, and Trackwise.

PROFESSIONAL EXPERIENCE

Pharmaceutical and Medical Device Consultant

Confidential

Responsibilities:

• Long term Quality Manager consulting positions wif up to 5 direct reports
• Developed annual audit schedules for company’s Quality Assurance Department
• Presented audit results to client and vendor senior management during closing meetings
• Wrote reports in accordance wif company SOPs and FDA Regulatory Requirements
• Conducted Clinical site audits
• Performed Mock FDA preparation inspections
• Created Supplier Quality programs and performed audits of critical suppliers
• Created Internal and External Audit programs and was lead auditor for both programs
• Maintain and improve Supplier Quality Program including supplier selection/qualification, compliance checks and audit scheduling
• Maintain teh external audit schedule and coordinate external audits
• Review and approve audit reports
• Maintain and improve product specification files and procedure
• Establish a regulatory surveillance process and standard operating procedure
• Assess Quality Agreements for remediation and assist wif implementation of Quality Agreements for new and existing suppliers
• Escalate any critical findings or compliance roadblocks to QA Management in routine review meetings or according to internal escalation procedures
• Support regulatory inspection management, serve as subject matter expert for supplier evaluation/QA related topics

Manager

Confidential

Responsibilities:

• Manage teh Quality Management Systems
• Managed CAPA, Non Conformance System, CAR, Complaints, Training, Internal Audit, Supplier Audits.
• Lead in Regulatory, ISO and Customer Audits
• Managed Supplier Qualification process.
• Auditing of Aseptic faculties manufacturing combination products
• Establish, manage and maintain a Quality Management System
• Supervise Department Employees
• Auditing of sterilization facilities
• Managing CAPA, Deviations and Non Conformance Systems
• Creating and managing annual Internal and External Audit schedules
• Provided Internal Auditor training to all employees. Cost savings of $5000 per year.
• Developed Regulatory Inspections procedure
• Assisted in teh development of Device Master Record.
• Management of Device History Files
• Assisting RA and Marketing wif teh development of labeling for each product, review and approval to ensure all labels meet regulatory requirements
• Maintained site FDA Establishment and Device Registration
• Perform preparation audits for Regulatory Inspections, including product Pre-Approval, ISO Certification, European Inspection
• Supplier Qualification and For Cause Audits, draft audit responses.
• Training: GMP, Good Documentation Practices, Deviation/Investigation Performance and Writing, Root Cause Analysis, Auditor Training and Certification, Batch Record Review, Regulatory Audits

QA Specialist III

Confidential

Responsibilities:

• Implemented and managed internal/external audit program. Developed yearly audit plans for both. Lead Auditor on assigned audits.
• Implemented and managed batch review schedule
• Managed Deviation and CAPA program.
• Project Manager for new commercial labeling operations wif contracted packaging and labeling facility.
• Successfully managed project to bring commercial labeling on site to reduce costs.
• Developed and performed all GXP training programs.
• Developed Recall and Complaint Management Systems.
• Reviewed/Approved SOPs, Change Controls, Test Methods, Validation Reports, and Protocols.
• Developed a pro-active weekly walkthrough audit plan for Manufacturing and QC Laboratory.
• QA Support for investigations of all phases of manufacturing operations including QC Laboratory.
• Final approval authority for release of raw materials to manufacturing.
• In process product disposition and problem resolution responsibilities.
• Review and approval of in-process and final QC testing for product release.
• Developed and implemented cGXP, ICH E6 and Q7A Guidance training.
• Reviewed and approved changes to controlled documents.
• Revised SOPs and Batch Records. Reviewed and approved final records related to product release.
• Assisted wif teh management of teh Exception and Non-Conformance (Deviation) reporting and CAPA systems.
• Developed a Batch Record Review Training program for manufacturing that reduced batch record errors into QA by 90%.

Compliance Consultant

Confidential, PA

Responsibilities:

• Responsible for maintaining teh stability study program for Rotavirus vaccine.
• Managed destruction of remaining Rotavirus Vaccine on site after FDA Recall. Coordinated wif FDA and DEA.
• Assisted wif writing and execution of special study validation protocols.
• Responsible for assisting wif internal audits; process, system and compliance.
• Responsible for cGMP training activities, developing and performing training.
• Member of ISO Certification Auditing Team.