Quality / Validation Engineer Manager (Chemical Engineering and MBA)

John R. Ahmuty

Jamestown, NC ***** 336-***-****

http://www.linkedin.com/in/john-ahmuty--quality-che-mba ********@*****.*** Quality Assurance / Validation Manager

Assures Robust Processes Using Continuous Improvement & Life Cycle Approach Methodologies Chemical engineer having diverse work experience with broad spectrum of FDA-regulated and ISO 9001 / 13485 certified industries. Process knowledge corresponds to range of products, including biotechnology, Rx and OTC pharmaceuticals, plasma fractionation bio-pharmaceuticals, medical devices, nutritionals, cosmetics, and traditional cigarettes (new to FDA regulations). Companies include new, modified, and small-scale to large manufacturers inclusive of late clinical phase and commercial production. Strengthened knowledge includes validation and change control leadership, technical product transfer, cleaning / sanitization program optimization, regulatory submission support, facility-wide GMP audits, risk assessment, product non-conformance dispositions and trend analyses, procedural optimizations, continuous improvement projects, and batch record approvals. Effective servant leader who provides guidance with justified decision-making based on cautious approach and logical business-mind. Loyal, detail-oriented, and passionately motivated.

Expertise in:

− Quality System Management

− GMP (CFR Part 11, ICH Q7) Compliance

− Continuous Improvement (Lean Manufacturing)

− Statistical Analysis (SPC, Cpk)

− MasterControl / Statgraphics

− Quality SME / GEP Design

− CAPA / FMEA / HACCP

− Technical Writing

− Data Interpretation / Presentation

− FDA Audit Host Support

Professional Experience

ITG BRANDS / LORILLARD, INC., Greensboro, NC 2008 - 2020 Senior Quality Engineer / Product Quality Supervisor Provided quality / compliance / audit oversight. Performed QA / QC management including training, job scheduling, and performance coaching for Quality Inspector direct reports (up to 12) while establishing GMP procedures and validation planning strategies for FDA-regulated cigarette manufacturer. Investigated consumer complaints and documented, inspected, examined risk, and determined raw material and product non-conformance dispositions.

• Analyzed / presented product non-conformance and consumer complaint KPI trends to reduce quality reject waste and increase market share, decreasing product non-conformance RCA, CAPA, and PDCA implementation measures and finished product rejection 75% ($422K annual savings), lowering completed product non- conformance count rates 30% and yearly count for top consumer complaint defect 15%.

• Implemented, verified, and performed facility-wide training for new Quality score metric system as lead indicator for determining operator behavior trends and machine malfunction issue trends.

• Planned and developed operator quality inspection procedure audit program, verifying compliance rates.

• Designed efficiently suitable sampling plan procedures and acceptance criteria for product quality inspections used during brand changes, equipment qualification start-ups after maintenance changes, and defective product frequency analysis.

• Improved machine OEE by reducing defective products (World-Class Operations Management Program leader).

• Presented “Lessons Learned” documentation as safety and quality awareness tools.

• Trained operators on statistical process control, corresponding adherence to SPC rules, and facility-wide good manufacturing / documentation practices, increasing process control (> Cpk), and enhancing product characteristic consistency.

• Planned and established validation and change control programs via policy, master plan, and procedures, following FDA regulations, ASTM E2500-07 life cycle approach, and ICH Q9 Quality management risk principles. John R. Ahmuty ********@*****.*** Page Two

ITG BRANDS / LORILLARD, INC. (Continued)

• Prepared and executed validation protocols for new and transferred equipment, ensuring GEP / product integrity ($75 million capital project).

o Hauni Cigarette Makers (Protos 90 and M5), GD Packers (H600), Filter Makers (KDF6). o Sorter programming suitability qualifications relating to leaf blends - detection level criteria design. o R&R analysis for new cigarette test stations - calibration procedure implementation. QUALICAPS, INC., Whitsett, NC 2005 - 2008

Department Head of Validation and Safety

Initiated, guided, and led Validation Department, which included change control program at international hard gelatin capsule manufacturer. Environmental health and safety leadership and administration responsibilities were added as promotional duties. Hired and managed permanent employees / contractors.

• Determined suitable level of testing corresponding to business and regulatory constraints, better aligning with ASTM E2500-07 industry guidelines, which streamlined validation process.

• Prepared and executed validation master plans (MP’s), installation qualifications (IQ’s), operational qualifications

(OQ’s), performance qualifications (PQ’s), cleaning validations (CV’s), process validations (PV’s), analytical test method validations, standard operating procedures (SOP’s), and change control study plans, providing documented evidence that equipment and processes consistently produce desired results.

• Facilitated teams to implement new and improved processes via lean six sigma manufacturing project leadership, including increasing gelatin mix efficiency, reducing product changeover times by more than half, and defining enhanced cleaning practices.

• Revamped cleaning program by optimizing procedures via cleaning agent rinse verifications and microbial analysis, consistently reducing product contamination / adulteration through means of scientific verification.

• Analyzed and communicated technical test data that drove continuous improvement opportunities.

• Collaborated with Engineering to ensure GEP design for reverse osmosis water system installation modifications, proactively confirming consistently high-quality ingredient water. BANNER PHARMACAPS, INC., High Point, NC 2001 - 2004 Validation Engineer

• Validation management of gel enrobed drug equipment / processes for support of FDA regulatory submissions.

• Prepared / executed validation MP’s, IQ’s, OQ’s, PQ’s, CV’s, PV’s, SOP’s, and change control plans.

• Led the technical transfer suitability of potent compounds and DEA regulated pharmaceuticals.

• Completely developed, launched, and managed validation cleaning program based on product / equipment matrix, worst-case active ingredient toxicity / minimum therapeutic dose ARL’s, campaign verifications, and dirty hold times. Additional Professional Experience

GILLETTE, Andover, MA, Senior Quality Engineer

KMI / PAREXEL, Waltham, MA, Senior Validation Engineer Consultant CARGILL FERTILIZER, Tampa, FL, Co-op Process Engineer Education & Certifications

− Master of Business Administration (MBA), University of North Carolina, Greensboro, NC

− Bachelor of Science (BS), Chemical Engineering, University of Florida, Gainesville, FL

− Certified Quality Auditor, American Society for Quality

− Certified Quality Engineer, American Society for Quality

− Helping Individuals Lead Successfully, Staub Leadership International

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