Quality Assurance Control
Resume:
IRINA REPP
*******@*******.***
OBJECTIVE
Seeking a position in the pharmaceutical/biotech/medical devices industry
where my previous experience and education will be utilized to achieve
rewarding and long-term growing opportunities.
QUALIFICATIONS SUMMARY
Significant work experience in the GMP/GLP FDA regulated industry,
including over 12 years of experience in Quality Assurance and Quality
Control departments.
EXPERIENCE
American Peptide Company, Vista, CA 03/2008 -
03/2010
Quality Assurance Supervisor
Head of Quality Assurance Department, direct report to VP Quality. Daily QA
operations, QA staff and systems development and management to ensure
compliance with all quality, regulatory and GMP/GLP requirements.
. Auditing, evaluating and improving existing procedures / policies to
bring Quality System to GMP/GLP regulatory requirements
. Reviewing and disposition final product, creating and approving
Certificate of Analysis
. Training entire company on Quality System procedures / policies, QA
staff on-job training
. Leading QA meetings with Upper Management and Heads of all Departments
. Assigning and managing daily activities of QA staff, weekly department
meetings
. Managing and handling critical Quality Systems, review, approval and
disposition of Deviations, CAPAs, Change Controls, Non-Conforming
Materials, Product Complaints, Return/Recall, OOS, etc.
. Interacting and communicating quality related tasks and issues with
various company personnel and departments
. Review and approval various documents, such as Specifications, SOPs,
Protocols and Reports for Stability Studies, Qualifications,
Validations, other
. Performing Internal Quality Audits
. Performing External Audits, vendors/services evaluation and approval
. Managing and handling Client/Customer audits
. Communicating with customers and resolving all quality related
questions, questionnaires, providing all required information
Achievements:
Improved and revised 80% of existed Quality Systems procedures:
Deviation system, labeling of final product, Product Complaints, Return and
Recall, Out of Specification report, Document Creation and Change control
and other.
Created missing Quality Systems:
CAPA, Batch Records creation and control, Labels accountability and
traceability, Raw Material Specifications control, COA creation and control
and others.
Improvement of vendors/service qualification system:
Revised policy/procedure and completed critical vendors' evaluation and
approval (questionnaires, audits, quality agreements).
Quality Meetings:
Invented and leaded meetings with Upper Management to resolve current
quality issues
Improvement of clients/customers quality audits and visits:
Represented company's Quality Systems resulting in no observations of the
audit/visit, including European Qualified Person audits, Japanese and USA
customers.
Improvement of Master and Production Batch records:
MBR template, system for BR coding, lot number assignment system, review
and approval procedure for production records. Significant improvement on
customers comments on BR review.
Amylin Pharmaceuticals, Inc., San Diego, CA 09/2007 -
03/2008
Quality Analyst
Review GLP Batch Production Records, communication and resolving issues
with contract manufacturer, final approval of Production Batch Lot.
Supporting Clinical Trial activities on different stages.
Hisamitsu California, Carlsbad, CA 09/ 2005 -
09/2007
Senior Quality Assurance Specialist
Variety of activities in Quality Assurance Department for supporting and
implementing Quality Systems to ensure compliance with regulatory
requirements.
. Preparing / Transforming company from GLP to GMP activities/requirements
. Assisting QA Manager during pre-approval inspection by FDA and client
visits
. Reviewing variety of GLP/GMP related documents included but not limited
to Batch Records, Stability Studies, Validation Protocols and Reports,
Material Specifications, labels, testing and release data, etc.
. Writing and revising Quality System SOPs. Assisting/ reviewing SOPs for
other departments
. Training personnel for Quality Systems procedures
. Managing or assisting the key QA systems: Change Control, Deviations,
Investigations and CAPA, Document Creation / Change Control, Material
Specification, Personnel Training Files, External and Internal Audits
Files, QA Logbooks, Equipment Files and other.
. Performing Internal Audits
. Managing equipment calibration and maintenance system.
. Providing daily assistance to QA Manager and other departments as
necessary
Allermed Laboratories Inc., San Diego, CA 08/1998 -
09/2005
GLP Quality Control Lead (Quality Control Unit)
. Part of Quality Unit. Establishing and leading GLP QC Laboratory since
2000
. Establishing GLP systems, methods and other applicable policies for GLP
QC department during early stages of Clinical Trails of the product
. Participated in various company inspections by FDA
. Developing, optimizing and validating Test Methods for QC Laboratory
during different stages of Clinical Trail
. Writing, revising and training staff on SOPs for the Laboratory equipment
and methods
. Managing Stability Program: Writing Stability Protocols and Reports,
coordinating, testing, reviewing and processing data for Stability
Program
. Reviewing and signing QC part of Batch Records; and Environmental
Monitoring records
. Approving and releasing of Raw Materials, In-Process and other items
. Managing of Equipment and Method Validation Program: writing Validation
Protocols and Reports, training personnel, performing testing,
calculations, overseeing validation process
OTHER COMPANIES AND FIELDS
Industrial Chemist-Hygienist (Ukraine, DneproPower)
1989 - 1996
Medical Laboratory Technician (Ministry of Public Health)
1982 - 1989
CERTIFICATES
FDA's cGMP for Finished Pharmaceuticals - Certified by RWTUV, USA, March,
2006
TRAINING COURSES
(1) How to prepare for a system-based inspection. Understanding the FDA's
risk-based inspections approach and ensuring compliance - August, 2007
(CfPIE)
(2) Mastering Your Performance as a QA Professional - November, 2006 (PTi)
EDUCATION
M.S. Chemical Engineering - Zaporozhye Industrial Institute, Ukraine, 1983
- 1989, (Evaluation of Equivalence of Diploma in USA, 2005)
B. S. Medical Laboratory Technician - Zaporozhye Nursing School, Ukraine
1979-1982
Computer Programs: MS Word, MS Excel, MS Access, Photoshop, Acrobat Reader
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