QA Leader/ISO,GMP Coordinator
Resume:
RESUME
HALYNA MYRONYUK
Winthrop Harbor, IL 60096,
*********@*****.***
Objective:
Seeking a challenging career that utilizes my skills in my area of competence, enriches my knowledge
and gives me a chance to be part of a team that contributes towards the growth of the organization,
thereby yielding the twin benefits of job satisfaction and convenient professional growth.
Education Qualification:
Achieved Master of Science Degree in Biology and Chemistry from the Yuriy Fedkovich National
University, Ukraine at Biochemistry as a major in the year of 1998.
Strengths:
Very flexible and adaptable to change.
Responsible, operate with integrity and team work.
Learning attitude and logical approach.
Computer literacy skills in programs that applicable to role.
Solid written and verbal communication skills.
Ability to independently define problems, collect data, establish facts and draw conclusions.
Professional skills:
- Working knowledge in quality system, GMP and Allergen training, records keeping and training validation;
- Working knowledge in implementing and maintaining of ISO 9001:2008 and GMP;
- Experience in implementing international and European GMP practices (DIN EN 15593, IPEC for Pharmaceutical excipients standards);
- Working knowledge of FDA 21CFR820; in particular 820.30 GMP;
- Experience with establishing of quality objectives following company policies and establishing procedures;
- Working knowledge of Molding Process (Injection, Extrusion, Stretch Blow), labeling, sleeving and screen printing processed;
- Working knowledge of design review, design verification, design validation, design transfer, design changes and history file;
- Working knowledge in preparing Product Control Plan, Product and Process FMEA and First Piece Article, Mold Qualification Process;
- Proficient using laboratory equipment (microscope, pH meter, spectrophotometer, moisture analyzer, refractometer, caliper, micrometer, wall thickness tester, force gauge, compression tester torque meter, height gauge), handling chemicals;
- Proficient in leading Internal and External quality and GMP audits including third party auditing;
- Proficient in Gap Analysis techniques, continual improvement, corrective and preventive actions;
- Proficient in inside and outside pharmaceutical sales;
- Proficient in Microsoft Office and use of Word, Excel and PowerPoint;
- Excellent organizational and communication skills;
- Excellent analytical and interpersonal skills;
- Good leadership skills;
- Excellent problem-solving skills;
- Dependable and reliable professional;
- Creative with an enthusiasm to learn;
- Pleasing personality that bonds well with clients and co-workers;
- Zeal for success with aptitude to establish goals and develop strategies to achieve them.
Work Experience (23 years) and achievements:
Quality Assurance Leader and ISO/GMP Coordinator at Monarch Group.
(December 2011- at present).
- Implemented new for company ISO 9001:2008 quality standard and completely implemented GMP system.
- Performed gap analysis (system and product) and implemented corrective action plan.
- Established training plan and matrix; trained all employees on ISO and GMP policies, procedures, work instructions and forms.
- Accurate collecting and keeping of quality, product and training records.
- Successfully passed all external quality and GMP audits including SGS third party audits.
- Performed internal quality and GMP internal audits.
- Championed customers and vendors CAPA implementation and validation.
- Conducted process, system and product audits.
- Developed Hazard Analysis of different product for GMP control.
- Championed Pest Control program.
- Coordinate organization of Management Review meetings, its agenda, leading the meetings, distributing the minutes, championed the responses and validation of corrective actions.
- Coordinated with customers on quality management system and GMP requirements.
- Planned improvement of product quality activities.
- Prepared the Product Control Plan, FMEA for customers.
- Implemented new laboratory software for mold qualification and start up analysis using all test equipment and gauges with complete saving of electronic files for product history.
- Active team member of End of Run analysis, design review, post product review and
continual improvement meetings.
- Improved products traceability in 35%.
- Performed annual Mock Recalls in less than 1 hour.
- Met deadlines consistently.
- Improved QA department efficiency and customer service by overhauling previously haphazard filing system.
- Participated in monthly safety meetings as a member of safety committee and validated corrective
actions.
Quality Assurance Auditor at Jelly Belly Candy Company (August 2005 - December 2011).
- Performed quality audits of all departments (including proof reading, verification of formula
parameters, ingredients, labels, ingredients statements, nutrition facts).
- Trained and supported new QA auditors.
- Successfully used and trained all QA auditors on new laboratory and inventory software.
- Performed daily, weekly GMP inspection, provided reports and validated corrective actions.
- Participated in monthly safety meetings as a member of safety committee and validated corrective
actions.
- Performed raw materials receiving and approval including testing.
- Analyzed product using laboratory equipment against product specification.
- Revised product formulas by calculating all ingredients, creating different batch sizes and converting to
metric system for international formulas.
- Developed new laboratory procedures, product operation procedures and sanitation procedures.
- Developed new glass verification program as a part of product Hazard Analysis.
- Participated in all new product/new formulas trials with R&D department.
- Worked on many special project supporting R&D department by performing testing, analyzing data and creating reports.
- Supported Inventory Control department in annual product inventory.
Sales Manager at Joint Russian-Ukrainian Pharmaceutical Company “Pharm Invest”, Ukraine.(May 1994 – September 2003).
Planned and launched distribution in 3,000 retail drugstores in 60 days and 15 largest whole sale corporations.
Interviewed, hired and trained all sales personnel
- Captured customer requirements in terms of forecasts and evolved the organisation’s sales budget as part
of the business planning process.
- Gathered customer requirements and transforming the requirements into actions.
- Utilized extensive knowledge and skill of transportation logistics to significantly improve efficiency of
deliveries by 40%, effectiveness of manpower by 35%.
- Grew new product sales 100% in 120 days and sustained 25%-45% annual sales growth for four
consecutive years by introducing new marketing initiatives, forging effective strategic alliances,
implementing innovative sales techniques.
- Profitably managed 40-65% growth in total business during six years.
- Evaluated Sales Department employees annual performance and achievements.
- Developed sales employees award program and other benefits plan.
- Attended medical conferences organized by Novartis, Sanofi, Yamanouchi, Merk, Berlin Chemie,
Pfizer, Boehringer Ingelheim, Nycomed, Galena, Polfa when launching a new product in Ukrainian
market.
- Developed a price list using Excel macros to calculate the final selling price and converting different
currency.
- Helped in preparing custom paperwork and supplying necessary custom approval documents to
customers and auditors.
- Supported customer external audits and audits from financial organizations.
Science Specialist at Medical-Ecological Research Institute. Ukraine. (January 1991- May 1994).
- Performed complex testing in defining of heavy metals in the atmosphere in a way that maintained high
quality of results.
- Traveled domestically to attend the medical and ecological conferences; to learn and purchase new
laboratory software.
- Trained all laboratory personnel in new laboratory software.
- Streamlined laboratory procedures 30% by managing a helpful inventory system for supplies and
equipment.
- Participated in a national ecological program dealing with 1986 Chernobyl atomic station explosion
issues.
- Supported testing in Immunology laboratory and Water laboratory.
- Worked in a special project with Immunology laboratory on testing a new medicine.
Laboratory Assistant at Ecological Center “UkrEcology”. Ukraine. (September 1989 – January
1991).
- Assisted in general laboratory and clerical duties which increased laboratory efficiency by 40%.
- Helped in revising laboratory procedures.
- Improved laboratory filing system by 45%.
- Developed electronic files for each customer with all supporting electronic documentation.
- Assisted in National Ecological program with developing of ecological passport for each city
manufacturer.
- Trained 5 entry level lab assistants.
- Assisted in monthly and annually inventory of supplies.
Languages Known: English, Ukrainian, Russian.
References available upon request.
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