Manager Quality

Luma Shoumali

• **** Asheboro St. • Frisco, TX, *5035 • 469-***-**** • ac69sw@r.postjobfree.com

PROFILE: Self-starter, highly motivated, pharmaceutical professional with 10+ years of experience assuring organizational cGMP, CFR and ISO 9001:2000 compliance. Accomplished in quality compliance, deviations investigations, CAPA, auditing, training, timely delivery of products, resources re-allocation, cost reduction, project management and increased productivity.

Winner of different recognitions of excellence.

PROFESSIONAL March 2016 – January 2018

EXPERIENCE: Hikma Pharmaceuticals – Packaging Manager Increased productivity by initiating and ensuring implementation of lean projects, standardization and process optimization. Ensured quality compliance and plant readiness for any unannounced regulatory inspection. Ensured successful execution of plans, problem solving, and timely delivery of high quality products. Coached and trained staff, re-allocated resources to ensure cost-efficient compliant operations. Led a team of 40 members, including packers, operators, and supervisors. Initiated & Approved change controls. Developed and monitored division budgets.

Minimized quality complaints related to the packaging department.

Led 2D barcode implementation project.

Initiated and led the first online visual management project across the group.

Increased the overall speed of major machines by 15%.

Increased safety awareness among the staff.

Achieved 1st place across 6 sites implementing change and lean projects. September 2006 – February 2016

Hikma Pharmaceuticals – Quality Compliance & Training Manager Hosted regulatory inspections including US-FDA, European regulatory authorities, Middle Eastern and North African (MENA) authorities. Prepared comprehensive responses for inspections’ observations. Performed internal audits for the FDA six systems audits, and audits for ISO requirements. Conducted and approved investigation for deviations, and proposed appropriate CAPA. Created, reviewed and approved SOP’s. Approved annual product review reports (APR) for US and EU products. Provided customer support for quality related inquiries. Identified training needs and created a comprehensive training plan for employees per level. Performed cGMP, technical and hands-on training to advance the understanding of regulatory and internal quality requirements. Updated training materials to ensure personnel engagement. Performed cGMP gap analysis. Developed and followed up on the action plan / solutions to correct the gap findings. Performed new guidelines gap analysis, developed and followed up on the action plans to meet these new guidelines in a timely manner. Conducted quarterly and escalation to management meetings. Pre-approved quality agreements with sister companies and other international pharmaceutical companies (for under-licensed products).

Created new systems to ensure meeting and exceeding regulatory authorities’ expectations such as escalation to management of significant quality incidents, new guidelines’ review, and CAPA effectiveness. Ensured compliance with regulatory and internal quality policies and procedures. Ensured timely closure of deviations, audit responses, and APR’s. Met key milestones in the implementation of quality projects such as RIMS implementation.

EDUCATION: Masters of Science in Biological sciences July 2004 Major in Molecular Microbiology

Bachelor of Science in Biological sciences June 2002 ADDITIONAL

SKILLS:

Knowledge and experience in US FDA, European and MENA heath authorities, CFR, ISO 9001: 2000, GMP's & GLP's.

Languages: English & French; verbal and written communications.

Microsoft office applications.

RIMS & SAP.

Contact this candidate