HIGHLIGHTS OF QUALIFICATIONS:

13+ years experience in coordinating all aspects of the Quality Program, such as
developing and administering the program, training, coaching employees, and fac
ilitating change throughout the organization. Quality Management Representative
and responsible for establishing policies, procedures at all levels to ensure t
he quality assurance program will meet or exceed internal and external client's
needs and expectations. Established procedures for a well documented CAPA progr
am to ensure timely implementation of CAPAs.
SUMMARY:
Project Management:
Administered projects on all aspects of Quality Control and Quality Assurance fo
r drugs and biologics API and final products in Pre-clinical, Phase I, Phase II,
Phase III Clinical trials and Commercial production. Administered multiple proj
ects within the organization. Excellent people skills. Strong knowledge of GMPs
. Quality Management Representative. Chaired Quality System and Management Rev
iew Meetings. Regulatory Support:
Facilitated and wrote various areas of the CMC sections for regulatory submissio
ns on new and existing drug products, Annual Product Reviews, Managed regulatory
compliance audits and responses to, European and US regulatory agencies. Superv
ised compliance to cGMP standards, due diligence and client audits on new and ex
isting drug manufacturing contracts. Re-organized Quality on a company wide basi
s to meet FDA's expectations for PAI.
Analytical and Microbiological Skills:
Trained technicians on various analytical assays using, UV-spectrophotometer, FC
A, HPLC, cIEF, IEF, SDS-PAGE, ELISA, LAL by Kinetic Turbidimetry, End Point LAL,
Bioburden, Cell Growth, Gram Stain, EM monitoring using MET-ONE particle Counte
r, RCS, RODAC plates, and managed the stability program.
Due Diligence:
Administered budget for the Quality group through Vice President of QS and RA.
Established a well documented training program for technicians and managers with
in the organization.
Established procedures for a well documented CAPA program to ensure timely imple
mentation of CAPAs.
Organized and Managed Due Diligence, Client and regulatory agency inspections.
Job History:
Senior Director, Quality Assurance
*Peregrine Pharmaceuticals, Inc. / *January 2006 to Prese
nt
Avid Bioservices Inc- Tustin, CA January 2002 to Prese
nt
(*Avid is a wholly owned subsidiary of Peregrine, previously known as Techniclon
e Corporation)
Peregrine Pharmaceuticals Inc is the parent company. My job responsibilities ar
e the same for both companies. Basic Job functions and responsibilities:
* Quality Management Representative:
* Ensure that processes needed for quality system are established, implemented a
nd maintained
* Report to Senior Management on the performance of the quality systems, and any
needs for improvement.
* Ensures the promotion of awareness of client requirements throughout the organ
ization.
* Serve as the liaison with external parties on matters relating to the quality
management system.
* Provide assistance throughout regulatory and client Quality audits.
* Organize and Chair Management Review Meetings and Quality Reports
* Manage Regulatory Agency Inspections
* Interact and manage Regulatory teams from various regulatory agencies such as
Health Department of Upper Bavaria, Paul Ehrlich Institute, EU, FDA, ISO, Client
's Regulatory contractors, Client due diligence teams.
* Communicate and provide response to regulatory agencies in a timely manner.
* Oversee and Manage Validation, QC Micro, Document Control, and QA Departments.
* Oversee IND updates, Annual Product Reviews and assist with submissions to the
FDA and other regulatory agencies.
* Review Batch History Records and disposition drug substance and drug product l
ots for Clinical and Commercial Use.
* Manage accurate, reliable, efficient, and timely product lot disposition to cl
ients and on time delivery of product.
* Oversee internal and external quality system audits/inspections of vendors, co
ntract lab services and component manufacturers to ensure compliance with applic
able regulations, CGMPs, ICHQ7 and other regulatory guidelines, ISO 13485, 21 CF
R210-211, 610, 820 regs to meet FDA,CBER, Team Biologics, EMEA, and other worldw
ide health authority expectations.
* Developed procedures to ensure compliance with applicable regulations/guidelin
es, ISO standards, PDA, USP/EP, and industry standards, as applicable.
* Developed and wrote the Quality Manual, Quality Policy and Site Master File.
* Prepared audit reports for Critical Suppliers, Vendors, and Contract Testing L
abs regarding observations and concerns and provided recommendations for correct
ive action(s).
* Developed DR, NCMR, OOS, CAPA program and implemented procedures for tracking
corrective action commitments until closure.
* Guide auditors to coordinate resolution of quality issues with suppliers and m
onitor quality metrics. Train auditors to perform internal quality system audit
s.
* Prepare coordinate and schedule tasks and set objectives for QCM, QA/ Document
Control personnel.
* Set policies and procedures in place to continuously improve the Quality Syste
ms.
* Revise and re-write documents such as Quality Manual, Site Master File, Qualit
y Policy, CMC Sections, company SOPs, Test Methods, Formulation Methods, Raw Mat
erial Specifications, Batch Production Records and related forms.
* Ensure the timely update of documents for GLP, GCP and cGMP compliance. Overse
e employee training program and secure archival of training records.
* Implement the importance of following cGMP and incorporated Total Quality Mana
gement on a company wide basis.
* Write and establish Project Authorizations, Quality Agreements, Contract Manuf
acturing Agreements, Communicate technical, and quality information to all clien
ts.
* Establish measures for product and process quality and provide upper managemen
t with status reports of all studies, projects, and department activities.
* Manage outside storage facility for Document Storage. Deal with vendors, inte
rnal and external clients and suppliers on quality related issues
* Prepare Annual Product Quality Reviews/ Quality Reports and submit
to Executive management including president/CEO.
* Establish a structured system of procedures ensuring that activities, products
, and services conform to requirements
* Plan systematic activities that are necessary to provide adequate confidence t
hat the product or service meets pre-determined requirements
* Participate in assessments of ongoing operations from QA perspective and provi
de input as needed to maintain and/ or improve upon compliance issues.
* Provide the oversight, direction and guidance needed to develop Total Quality
Management, for policies and procedures as required for products manufactured an
d services provided by Avid Bioservices Inc.
Manager, Quality Control
*Peregrine Pharmaceuticals Inc- Tustin, CA May 1997 to Dec 2001
(*Previously known as Techniclone Corporation.)
Basic job functions and responsibilities:
* Inspections, Internal and potential supplier audits.
* Initiation and revision of controlled documents (SOPs, Test Methods, Raw Mater
ial Specifications).
* Raw material, in-process, and final product testing.
* Contract testing and sample shipment.
* Training of QC technicians on test methods.
* Transfer and assist in the validation of new methods/procedures.
* Implementation of drug product/substance stability testing program.
* Continual improvement in quality and integrity of data reported by the QC Depa
rtment.
* Assisted with research and development projects.
* Budget and expansion planning.
* Client and regulatory audit preparations.
* Test record storage/archival.
* Generated C of A's for product disposition.
* Maintained lab supplies.
* Audited contract facilities.
* Investigation of Out Of Specification results.
* Ensured compliance with applicable regulations.
Previous Career History:
Chemist - The Hartley Company, Costa Mesa, CA
Science Teacher-Orange Crescent School, Garden Groove, CA
Chemistry Teacher - Torah High School, Dallas TX
Chemistry and Physics Substitute Teacher- Green Hill High School, Dallas TX
Chemistry Teacher - St. Joseph's Convent High School, Pakistan
Chemistry Teacher - Ed-Rec Center, Karachi Pakistan
Educational Background:
MS Physical Chemistry BS Chemistry / Microbiology / Zoolog
y
University of Karachi, Pakistan St. Joseph's College, Pakistan
Honors: GPA 4.0. Honors: First Division
1984 1982
Certificate of Mathematics
University of Karachi, Pakistan
Honors: GPA 4.0, merit student, graduated top of class
1985
Certifications and Seminars:
Certified Quality Manager Preparation Course (ASQ Series)
ASQ Orange Empire Section (0701)
2004
Irvine Valley College, California
1999 Process Based Auditing
ASQ Orange Empire Section (0701)
Mr. Dennis R Arter
2004
Introduction to Process Validation
ASQ Orange Empire Section (0701)
Ms. Linda Garetz
2004
 Corrective Actions/Preventive Actions
ASQ Orange Empire Section (0701)
Mr. Jack Dhuwalia
2003
Pre Approval Inspections
Southern California Chapter of PDA
Ms.Caryn McNabb
Mr. Jeff Huehn
2003
Regulatory Compliance- Biologics and Drugs
Avid Bioservices, Inc.
Mr. Ajit Simh
2003
US Regulations in Biologics
Quintiles
Elizebeth Gorden, Ph.D
1999 Hazardous Waste Handling and Disposal Certification
All-Chem. Waste Disposal Services
1999

Skills:
Managed Regulatory Compliance Inspections and Client audits
Directly interacted with regulators (EU, FDA, Department of Health, ISO auditors
, Due Diligence Audits, Client Regulatory Consultants)
Thorough knowledge of cGMP, GDP, GLP
Excellent training skills especially on various topics covered under GMP
Knowledge of applicable regulatory requirements e.g.: ICH Q7, EU, USP, 21 CFR Pa
rts 210 & 211, 600-610, 820, EU Annexes
Worked with Microsoft office applications e.g. Word, Excel, Power-Point, Access,
Project, other software such as Prism, Biolise, Soft-Max Pro, PACE MDQ 32Kt.
Highly organized, detailed, and motivated.
Teamwork, Management and supervisory skills
Dedicated to assuring a quality product
Excellent teaching and OJT (On the Job Training) skills
Memberships:
PDA
Seminars, Workshops
PDA News Letters & Technical Reports
Member Since 2002
American Society of Quality (ASQ)
Senior Member Biomedical Group
ASQ Orange Empire Clinics, Meetings, Workshops
Quality Digest, Quality Progress, Scope
Member Since July 1999
AOAC
ASSOCIATION OF ANALYTICAL COMMUNITIES
Seminars, and work shops.
Subscribe to News Letters
Member Since 2005
RAPS
Regulatory Affairs Professionals Society
Seminars
Member Since 2006
OCRA
Orange County Regulatory Affairs
Discussion Group
Meetings and Discussions
Member Since 2006