Quality Engineer Injection Molding

PEGAH SHIRAZI GUSTOVICH

+1-512-***-**** *****.*********@*****.***

Experienced and energetic strategy leader with more than 10 years of experience in pharmaceutical and manufacturing environments. Demonstrated intuitive understanding of Good Manufacturing Practices, Quality compliance and Federal Drug Agency (FDA) code of regulation. Strong analysis skills that include insight into successfully applying technological solutions and best practices to resolve business issues, while improving overall efficiency. Inspiring a positive morale, dynamic team environment, and confidence in managing daily operations of a fast-paced organization. Master of Applied Science, Industrial Engineering Concordia University, Montreal, Canada Bachelor of Engineering, Industrial Engineering Azad University, Iran Project Management Professional (PMP) PMI, USA

Internal Quality Auditing Certificate for ISO 9001 TUV Academy, Germany HOSPIRA / PFIZER / ICUMEDICAL 2011 – Present

Senior Project Manager – Strategic Programs, 2017 – Present (ICU Medical)

• Leading a $7+ Million project on re-branding all active market product due to company acquisition.

• Managed budget, developed schedule, and planned activities to meet project deadline for releasing product to market.

• Developed validation and qualification strategies to release product with new labels and enclosures.

• Reported bi-weekly updates to management and periodically presented project progress to senior executives.

• Single point of contact with suppliers to coordinate supplier activities. Conducted supplier visits for quality reviews.

• Managed day to day activities of 4 direct reports and cross functional project resources.

• Coordinated and managed production and scheduling of products with new labels.

• Managed commercial activities to launch the product with the new labels and new NDC numbers including e-catalog updates, customer notifications and inventory control.

• Executed change control and risk assessment to create and revise new specifications, new batch records and SOPs.

• Created new specification and remediated existing specification including third party manufacturing specification.

• Coordinated product changes, labels, and NDC numbers with regulatory affairs and obtained FDA approval. Senior Project Manager – Manufacturing, 2016 – 2017 (ICU Medical)

• Led $5+Million third party injection molding tool transfer project across all of the organizations manufacturing plants, impacting over 180 SKUs across the site.

• Developed bracketing strategy for qualification activities. Coordinated the qualifications activities of 10 validation line trials over the course of 6 months

• Coordinated validation and qualification activities at the injection molding contract manufacturing site to ensure compliance with Austin specifications and FDA code of regulation.

• Remediated new specifications for the transferred commodities. Established new test methods and equipment for testing incoming commodities to improve the overall quality level of incoming materials.

• Conducted risk assessment on introducing new commodities and specifications.

• Lead change control and documentation change to implement the transferred commodities into the site.

• Executed 10 First Lot to Stock (FLTS) approvals to commercialize transferred commodities.

• Controlled inventory levels of old and new commodities to ensure continuous supply of commodities to prevent down time.

PROFESSIONAL EXPERIENCE

EDUCATION & CERTIFICATIONS

Pegah Shirazi Gustovich +1-512-***-**** *****.*********@*****.*** Compliance Investigation Specialist/Interim compliance Manager, 2014 – 2016 (Pfizer)

• Coordinated compliance activities for the entire Austin site, documented, tracked, and reported compliance investigations and CAPAs to the site on a daily basis.

• Managed number of open and approved Exception Reports (Investigations),CAPA records, and effectiveness checks.

• As the lead Compliance Investigation Specialist, reviewed and approved ERs, CAPAs, and Effectiveness checks.

• Represented Quality Assurance (QA) investigation team for FDA and Health Canada audit resulting in a successful audit.

• Trained compliance investigators on Root Cause Analysis, Corrective Actions and Human Error Analysis.

• Created a training and certification program for the QA approvers.

• Conducted daily triage of new exception reports driving up on time initial impact assessment approval from 46% in Jan 2014 to 97% by the end of 2014.

• Led the Quality Systems for deviations, CAPAs, CAPA and management review board.

• Reported weekly and monthly Key Performance Indicators (KPIs) for deviations.

• Managed daily activities of three direct reports (two Quality approvers, and one CAPA coordinator.)

• Managed transition activities from Hospira quality systems to align with Pfizer Quality systems and processes. Supervisor, Complaint/Compliance Investigations, 2012 – 2014 (Hospira)

• Reduced the backlog of the complaint investigations from 800+ aging open complaints to 50 open (under 30-days old) complaint investigations and maintained the level by implementing process improvements and trouble shooting.

• Reduced aging FDA Field Alert from 200+ to 30 (under 45-days old) and maintained an acceptable level by implementing process improvements.

• Created processes to ensure timely communication with FDA regarding FieldAlerts, recalls and Dear Health Care professional letters.

• Represented Complaint investigation team for FDA and Health Canada audit resulting in a successful audit.

• Approved final complaint investigations for released product and identify a final disposition for market product.

• Conducted more than 50 NtMs (Notification to board of Executives across the corporation), accessed and communicated the risk involved with the product in the market, leading to filed action decisions including recalls or safety alerts.

• Created process and procedures to assess risk and identify respective field action decisions for market product.

• Restructured organizational chart and job description for the Complaint department. Hired and on boarded 8 full time employees and 5 contractors and managed their daily activities. Senior Quality Engineer, 2011 – 2012 (Hospira)

• Created standard operation procedures and business process for post market complaint investigations, root cause analysis and defect recognitions.

• Technical writer for the major complaint investigations, FDA Field Alerts and health care professional letters.

• Assured all exception documentations adequately addressed root cause, corrective, and preventive actions and product impact.

• Lead and trained Quality Engineer Technicians on post market complaint investigations, defect recognitions and root cause analysis.

• Proactively reduced variation and eliminated manufacturing defects (for examples leaker and particulates) by implementing Engineering and manufacturing process improvement and controls. For example, replacement of filling robots and adding additional in process testing.

CONCORDIA UNIVERSITY 2009 – 2011

Research Assistant (Mechanical & Industrial Engineering) BAMRAH CONSTRUCTION COMPANY 2008 – 2009

Quality Engineer, Construction

SABALAN MANUFACTURING 2006 – 2008

Quality Engineer, HVAC Manufacturing

Pegah Shirazi Gustovich +1-512-***-**** *****.*********@*****.***

• Good Manuf. Practices (GMP) • FDA Audits • Project Management

• Quality Compliance • Root Cause Analysis • Change Control Management

• Quality Assurance • 21 CFR Part 11 and 820 • Manufacturing/Operation

• Corrective Action & Prevention

Action (CAPA)

“A mathematical model for production planning in hybrid manufacturing-remanufacturing Systems”, Chen, M. & Abrishami, P. Int J Adv Manuf Technol (2014) 71: 1187 AREAS OF EXPERTISE

PUBLICATIONS

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