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Quality Supervisor

Frisco, TX
January 10, 2020

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Romany Kozman


Mobile: 972-***-****

Dear Hiring Manager,

As a young, motivated, and experienced individual who's already had a strong experience in the Quality field at the pharmaceutical companies, I am extremely interested in submitting an application with your company.

In the past 10 years, I have worked in one of the biggest pharmaceutical companies in Egypt. I started as “Microbiology Specialist” for 2 years. Then I worked as “Senior Quality Documentation Specialist” for 3 years. After that, I got promoted as “Quality Documentation Supervisor” for 4 years. In December 2018, I started the process to become “Quality Documentation Section Head” but I relocated to USA in January 2019. While processing my legal documents here, I invested my time as an “Independent Biology Tutor”. In September 2019, I got my EAD card and I got a job as

“Assistant Manager” at “Pie Five Pizza” to cover my expenses till I return to my career path again. In September 2019, I got authorized to work in USA at any employer without any requirement for a sponsorship. I am looking for a new challenge that will provide me with the opportunity to invest my experience and my skills in enhancing the human life by research and development. I understand that you will receive a large number of applications for this role. I do, however, believe that my motivation, commitment, and pre-existing skills will allow me to fit into your work environment and immediately start supporting the needs of your organization. I would appreciate the opportunity to meet with you to discuss my application at an interview. I have enclosed a copy of my resume for your consideration. I can be contacted at all times on the details provided above.

Thank you for considering my application.


Romany Kozman


8655 Brookhollow BLV, Frisco, TX 75034


Quality Supervisor

Delivering Accountability, Compliance, and Excellence Total Dedication in Implementing Procedures in Challenging Environments Attention to details, innovative, and result-driven Quality Supervisor with extensive experience in the pharmaceutical S.O.P. (Standard Operating Procedures) and the pharmaceutical audits’ protocol. Seasoned professional in identifying, analyzing, and resolving problems to meet the pharmaceutical standards and control cost. Adept in data analysis, operational process enhancement, and skillfully utilizing S.O.P. (Standard Operation Procedures) to evaluate, manage, and accurately assure meeting the pharmacopia standards. Committed leader in outstanding verbal and written communication skills, new software and systems implementation, provision of analytical report to make complex decisions directed at improving performance and optimizing laboratory processes to yield a decrease in all audits’ major and minor points. Highly skilled in merging customer and user needs with business demands, budgetary restriction and considerations of logistics to meet business deliverables. Product/Process Lifecycle Management Auditing Experience Ethical Conduct and Compliance Decisiveness Cross-Functional Team Management Accuracy Budget Responsibilities Efficient Time Management Efficient Organisational Skills

Technical Acumen

cGMP Standards Validation Protocols Oracle

SOP Compliance Calibration Plans Microsoft Office

ISO Procedures Audit Procedures SQL

FDA Standards Safety Guidelines C#

Pharmacopeia Standards Business Writing

Career History

Assistant Manager Pie Five Pizza – Frisco, USA

September 2019 – Present

I got my EAD card in September 2019 and I got this job to cover my expenses till I return to my career path again. Ø Perform the essential job functions of the team member position. Ø Direct team members and delegate responsibilities. Ø Perform register closeouts and bank deposits.

Ø Address and resolve guest concerns.

Ø Open or close store, including the execution of related responsibilities. Ø Manage all aspects of development and performance management of subordinates. Ø Forecast sales, schedule associates, and manage payroll based on business patterns. Ø Manage product ordering and inventorying, maintaining proper level of stock. Ø Owning the financial and guest satisfaction performance of the restaurant, reviewing and reporting relevant documents and information in a timely manner.

Ø Performs other related duties, as assigned by company management. Independent Biology Tutor Freelancer – Frisco, USA Febuary 2019 – September 2019

Moved to USA and was waiting for my EAD card so, I invested my time as an Independent Biology Tutor. Quality Documentation Supervisor EVA Pharma for Pharmaceuticals – Cairo, Egypt May 2009 – December 2018

Ø Update, review and manage SOP documentation work flow for QC processes. Ø Review of required batch release testing.

Ø Review of manufacturing batches from contract manufacturing partners. Ø Supplier documentation management.

Ø Assist in preparing Quarantine Release documents. Ø Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

Ø Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

Ø Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

Ø Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

Ø Support Management during external/internal inspections and participate in the management of external/internal inspections.

Ø Assist with external/internal audit preparation and responses to external/internal audit observations. Ø Review records and documents, for completeness and compliance with Quality System Requirements and ISO requirements.

Ø Manage and maintain Quality System documents and records. Ø Manage master documents (paper and electronic scans). Ø Prepare Annual Quality Summary Report.

Ø Monitor compliance with the document control procedures and requirements, controls deviations, and follows up on corrections.

Ø May assist in training staff in the document control processes and resulting procedures. Ø Update logs and the Document Management System for the documents being processed. Ø Administer document lifecycle for quality system and other business policies and procedures. Selected Career Benchmarks

Ø Passed the Hungarian Audit with ZERO major points in 2018. Ø Supervised issuing all the required documents for our new research center “MARC” in 2018. Ø Passed the European Union Audits with ZERO major points in 2011, 2014, and 2017. Ø Implemented urgent corrective action within 3 hours to avoid a major point in the Supply Chain System through the Saudi Arabian Audit in 2010. Eventually, we passed the audit with ZERO major points. Ø Passed all MOH Audits with ZERO major points.

Ø Passed all internal audits with ZERO major points. Ø Created a microsoft access database to follow-up daily with all documents’ requirments. Ø Spearheaded a team of 3 Quality Documentation Specialists and 5 Associates to support a rapid and smooth documentation procedures for all departments.

Showroom Manager Al-Etehad For Kingdom – Cairo, Egypt October 2006 – May 2009

Ø Achieve the sales target through a team of Sales Representatives. Ø Monitor, control, and manage business operations to meet customer expectations and company goals. Ø Maintain high level customer service and support both internal and external partners. Ø Handle the depositing of checks and watch for incoming wires. Ø Optimize and control operation expenses.

Ø Build good rapport with the customers in the market. Ø Monitor the sales and the products stock regularly. Ø Prepare a monthly sales and stock status report. Selected Career Benchmarks

Ø Achieved 134% of 2009 sales plan.

Ø Achieved 119% of 2008 sales plan.

Ø Achieved 107% of 2007 sales plan.

Ø Moved to use the e-mails as a communication system with our clients instead of the regular slow faxes which saved the company money and time. Also, avoided missing correspondences. Ø Managed more than 1,500 phone calls and 750 e-mails from clients; assisted with online access, statements, account information, and product issues.

Ø Troubleshot problems by communicating effectively and promptly with different departments and branches. Ø Spearheaded a team of 2 Sales Representatives and 2 Associates to support all customers’ needs. Ø Indirectly supervised people on warehouses as needed, and assisted Managers in the daily coordination and management of business operational activities.

Data Entry and IT Helpdesk

Ø Implement the purchasing requisitions and purchasing orders on the company access system. Ø Verify and correct data which coming from all branches where necessary. Ø Scan, index, and assemble documents in accordance with company standards. Ø Provide technical support for queries and issues related to computer systems, software, and hardware. Ø Respond to queries either in person or over the phone. Ø Guide users through problem-solving process.

Ø Install, modify, and repair computer hardware and software issues. Ø Resolve problems by running diagnostic programs. Selected Career Benchmarks

Ø Revised more than 900 purchasing requisitions and purchasing orders from all the company branches. Ø Rapidly corrected errors in these P.R. and P.O. before implemented it on the company access system. Ø Disinfected the Cairo branch computers from a virus paralyzed the work flow in November 2006. Ø Found a solution to continuously backup the company access system. Ø Improved the scanning process to increase efficiency and help meet deadlines. Education

Helwan University

Bachelor of Science, Biology, 2006


Ø Addiction Counselling Diploma, September 2017 – June 2018 Ø Academic IELTS Certificate, April 2017

Ø Negotiation Skills, May 2016

Ø Academic IELTS Certificate, April 2015

Ø General Counselling Diploma, September 2013 – June 2015 Ø Marriage Counselling Diploma, September 2011 – March 2012 Ø Time Management, July 2010

Ø English Language at AMIDEAST, November 2009 - April 2010 Ø English Language at the American University in Cairo, September 2007 - February 2008 Ø Fluent in Arabic (verbal/written)

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