PARNIA PADYAB

Phone: (***) *** - ****

acw73c@r.postjobfree.com

HIGHLIGHTS OF SKILLS AND QUALIFICATIONS

Master of Science in Organic Chemistry with over 5 years of experience in Pharmaceutical Industry

Extensive experience in QA and RA in pharmaceutical sector. Proficient in technical writing and reviewing

qualified documents such as Standard Operating Procedures (SOPs), Change Control, and Deviation

Proficient in the Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good

Documentation Practice (GDP) compliance

Proficient in Out of Specification Investigations and Implementation Corrective and Preventive Actions (CAPA)

Profound ability to troubleshoot, problem solving

Strong experience in HPLC, TLC, IR, and UV

Good communication and organizational skills

Self-motivated and flexible with ability to work in a fast paced environment

Good computer skills

CAREER HISTORY

Cosmetica Laboratories, Toronto-Canada (Co-op placement)

QA/QC Laboratory Technician September2015- November 2015

Performed variety of tests like viscosity, particle size, SG, Loss on Drying, Breaking Point, Dropping Point,

Hardness, IR, Bulk Density, for bulk and finished products.

Documented all test results

Biopharma Services, Toronto-Canada (Co-op placement)

Archiver, Compiler in Data Management and Medical Writing Department July2015-August 2015

Checked and Evaluated all parts of study such as Source Documents, Screening Files, Pharmacy and Regulatory

files

Prepared Report Tables, Study Reports for QC And QA deparetments

Hakim Pharmaceutical Company, Tehran- Iran (2009- 2014)

Quality Assurance Associate April 2012- July 2014

Supported QA Manager in achieving and maintaining compliance to CPL quality systems and GMP regulatory

requirements

Created and updated numerous SOPs, wrote QARs (Quality Assurance Reports)

Assisted clients with GMP compliance, quality systems management, and audit preparation

Documented SOPs and procedures as per ICH, GMP, and ISO

Ensured company adherence to cGMP, GLP, GDP, and internal procedures and protocols

Evaluated the manufacturing, packaging, in-process, raw material records and laboratory testing results to

determine compliance to Regulatory and GMP standards as well as internal procedures

Determined the release or rejection / recall of raw materials, in-process and finished products

Investigated of processes and production employees to solve current quality issues

Supported the determination and implementation of CAPA to drive continuous improvement within the production

environment

Fulfilled the requirements of the self-inspection program within operations ensuring procedures, processes and

records relating to Consumer Complaints and Annual Product Quality Reviews (APQRs) are reviewed for

compliance with cGMP and Quality Modules, as appropriate

Documented log books, caliberation records, temperature and humidity records, etc.

Mentored and Trained new QA employees

1of 3

Parnia Padyab 647-***-****

Regulatory Affairs Supervisor November 2010-April 2012

Reviewed current compendia, customer methods for changes in methods and specifications, Initiated change

control process for the necessary updates

Monitored changes in compendia and regulatory guidelines, emerging regulatory and industry trends related to

laboratory and analytical operations, instrumentation/computerized systems calibration, qualification or validation,

data reliability, specification development, and method development, transfer and validation Informed Management

of developments, and made recommendations on procedure / policy changes

Corrected and completed R&D and QC reports before sending to the Food and Drug Organization (Iran FDO)

Reviewed executed manufacturing batch records for completeness and to ensure performance of operations

according to batch records and applicable regulations and procedures, released acceptable batch records

Provided brochures and label statements in different packaging forms for new products

Performed GMP Audit/ Inspection of suppliers to ensure compliance with GMP regulations

Confirmed all regulatory documentations were collected, prepared, and stored appropriately

Reviewed and edited product labeling, package insert and summary of product characteristics to ensure compliance

with regulatory requirements

Collaborated with internal departments to discuss and provide solutions to regulatory issues and problems

Performed ingredient and label reviews, maintained site licenses and establishment licenses, collaborated with

product export and import department, offered regulatory opinions for new products

Collaborated with internal and external sources to request or provide data relevant to submissions

Verified active ingredients and finished products lab results were in compliance with related monographs

Trained new RA personnel

Regulatory Affairs Officer May 2009-November 2010

Reviewed and controlled batch production records

Reviewed and approved the R&D and QC documents and protocols related to method validations and Invitros

Assessed DMFs and CTDs of new formulated generic drugs

Prepared product stability protocols, Performed product release

Filled various drug registration and submission application forms for new formulated generic drugs

Reviewed all information included as part of regulatory submissions

Compiled DMFs for export

EDUCATION

Master of Science in Organic Chemistry, 2009

Azad University Central Branch, Tehran - Iran

Bachelor of Science in Applied Chemistry, 2003

Bu-Ali-Sina University, Hamedan Iran

CERTIFICATES

Basic, Structure and Documentation of Quality Management System(QMS) in accordance with ISO 9001, January

2013, TUV Academy Iran-Germany, QM611-IR11/0102

Hakim Pharmaceutical Company, Tehran- Iran:

Good Manufacturing Practice (GMP), 100 hours, 2009-2014 (annually)

General Validation, 10 hours, May 2011

Good Laboratory Practice (GLP), 30 hours, October 2010

Method Validation, 28 hours, March 2010

Gas Chromatography (GC), 8 hours, March 2010

Parnia Padyab 647-***-****

High Pressure Liquid Chromatography (HPLC), 20 hours, 2010

Common Technical Document (CTD), 60 hours, July 2009

Drug Master File (DMF), 40 hours, June 2009

COMPUTER PROFICIENCY

Chemistry Software Tools: Chem Office, Hyper Chem

MS Office suite: Excel, PowerPoint, Outlook

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