IRINA REPP

abm0eg@r.postjobfree.com

858-***-****

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

Contact this candidate