Manufacturing System

Inga Talyansky

** ******** ****, *******, ** ****9

908-***-**** 917-***-****

*********@*****.***

EXPERIENCE

August 2005 – present

Actavis (Alpharma) Pharmaceuticals, LLC., Elizabeth, NJ

QA Investigator/CAPA Specialist/Product Complaints:

- Writing/Reviewing/Approving Manufacturing & Packaging Investigations (TrackWise);

- Initiating and Managing CAPA System (TrackWise);

- Creating Deviation/CAPA/Complaints Monthly Metrics;

- Initiating Change Controls (TrackWise/QUMAS);

- Performing Deviation Annual Product Review (APR’s);

- Managing Customer Product Complaints System (AERS);

- Managing Training System (CAP);

- Assisting in Validation of Global Electronic Training System (ComplianceWire)

- Performing Internal Audits;

- Performing Manufacturing & Packaging Batch Record Review;

- Reviewing proposed changes to existing SOPs;

- Providing Support for Manufacturing and QA Doc/QA FPR Group.

April 2003 – August 2005

Alpharma Pharmaceuticals, LLC., Elizabeth, NJ

QA Inspector/Production Support:

- All Manufacturing Departments/Packaging Clearances

- In-process/finished product testing;

- Labels/inserts/outserts sampling/proofreading;

- Annual sample review; bulk/stability sampling

- Manufacturing/Packing Equipment Cleaning Validation (CV);

- Manufacturing/Packaging Batch Review.

2001-2002

Shire & Richwood Pharmaceuticals, Co., Rockaway, NY.

QA inspector:

- In-process/finished product testing;

- Manufacturing/Packaging Batch Review

EDUCATION

9/1999-6/2002 College of Staten Island, SI, NY.

9/1996-6/1999 Brooklyn College, Brooklyn, NY.

Biology and Liberal Arts

Courses on GMP, CAPA, ASQ – Certificates of completion

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