Project Manager Medical Device

shahida gul

Email: *********@********.***

Address: **** **** ***** ******

City: athens

State: GA

Zip: 30601

Country: USA

Phone: 408-***-****

Skill Level: Experienced

Salary Range: $80,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Shahida Gul, MSc, ASQ

1734 East Broad Street. Cell Phone: 408-***-****

Athens GA 30601 E-mail: ********@*****.***

SUMMARY:

* Extensive experience in pharmaceutical, medical device and chemical industry analytical laboratories

Established and implemented Statistical Process Control

* Laboratory management and analytical laboratory improvement, cGMP and GLP compliance and

problem resolution.

Document writing including SOPs, and validation protocol

* QA/QC functions for testing, batch record review, complaint handling, internal audits, supplier audits and

data analysis

* Ensure electronic documentation, software used in manufacturing and laboratory equipment meet 21

CFR part 11 requirements

* Training on cGMP and GLP compliance and problem resolution.

* Pharmaceutical process, cleaning and analytical methods validation.

EDUCATION

Clinical Laboratory Science Course Work:

(Adv. Medical Microbiology; Immunology; Pathophysiology)

Weber State University, UT

Graduate courses and research project-biochemistry-San Jose State, CA

M.Sc. - chemistry (biochemistry major)

B.Sc. - chemistry (minor statistics and zoology)

EXPERIENCE:

March 2007 to June 2010: RegenBiologics, Redwood City, CA

Senior Analyst, QA/QC

Responsibilities:

-Implement Q.C. efficiency program through audit, training and use of statistical Q.C. techniques, to improve and

to meet FDA, QSR and ISO 13485 requirements

-Manage all technical activities including technical review, supervision of laboratory staff, regulatory compliance,

safety, document preparation and review

June 2001 to October 2006: Allergan, Inc. Campbell, CA

Analyst, QA

Responsibilities:

-Increase facility efficiency with advanced computer technology (documentum) for the management of documents.

-Maintain electronic document control of manufacturing facility in compliance with

21CFR Part11 code

-Participate in regulatory audits (US and EU) and prepare responses to the agency

audit report

-Perform internal and supplier audits

-Write validation documents including process and analytical methods

-CAPA implementation and evaluation activities

November 1999 to May 2001: Tyco International, Fremont, CA

QA Engineer

Responsibilities:

- Oversee and improve document control activities

- Participate in the senior leadership team to manage and resolve product quality

issues.

- Manage RMA

- Deliver training on statistical process control to all employees.

-Perform a gap analysis to bring company QMS into compliance with the ISO-9001

standards

March 1993 to November 2000: Pycon, Inc., Santa Clara, CA

Chemist

Responsibilities:

- Participate in ISO-9000 certification activities

- Supervise quality control laboratory

- Perform complex chemical tests

- Evaluate test results, develop and modify procedures

- Establish and monitor programs to ensure the accuracy of tests

August 1986-September 1987: Cinna, Diagnostics, Abbotabad, Pakistan

Internship

Responsibilities:

- Examine microscopically blood and other body fluids

- Analyze samples for chemical content or a chemical reaction

- Determine concentrations of compounds such as blood glucose and cholesterol levels, etc.

Technical Experience:

Knowledge of most major chromatographic techniques including HPLC, GC. GCMS, and TLC

Familiarity with most pharmaceutical methodologies such as SDS-PAGE, Western Blot, as well

as traditional chemistry techniques (e.g. UV/Vis, pH meter, IR, NMR, etc),Documentum,

Paper port, Acrobat PageMaker, MS Office, Project Manager, ISO 9001, 13485,

cGMP/QSR, ICH guidelines, Mil-specs, UL specifications

Certifications:

ISO-9000 Internal Quality Auditing

Quality Auditing (CQA) by ASQ

Documentation Management and Control in the Pharmaceutical and Related Industries

Implementing an Effective Change Control System

cGMP for Biotech Drug Products

Hazardous Waste Training

Programming In C/C++

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