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Shahnawaz Sajid October 2009

Dr. Shahnawaz Sajid

PH: 00 92-300-******* Email: abnios@r.postjobfree.com

Suite B3/B5 Adeel Square Phase II Block 7 FB Area Karachi, Pakistan

EDUCATION

• PhD, (Pharmaceutical Chemistry)University of Karachi (Pakistan) 2009

MPhil, (Pharmaceutical Chemistry) From Karachi University 2006

EMPLOYMENT HISTORY

Consultant Pharmaceutical Operations Consultants Present

Manager QA Validation Getz Pharmaceutical Pvt. Ltd 2008

Senior Executive Validation Getz Pharmaceutical Pvt. Ltd 2006

Senior Validation Officer Hilton Pharma Pvt Ltd 2005-2006

Validation Officer Hilton Pharma Pvt Ltd 2004-2005

Quality Control Analyst Bristol- Myers Squibbs Pakistan Ltd 2002-2004

PROVIDED CONSULTANCY AT DIFFERENT SITES

• www.askabtvalidation.com

• www.ivthome.com

PROFESSIONAL EXPERIENCES

TECHNICAL

• Provided technical and validation support for pharmaceutical process.

• Followed aseptic processing guide lines and works with multiple functional groups to complete

media fill and any required investigations.

• Anticipated and assessed / prevented: technical problems from impacting product, project

management skills for several complex projects, adequacy of proposed corrective actions to

address root cause.

• Involved in IQ, OQ and PQ of manufacturing equipments.

OTHER EXPERTISE TECHNICAL SKILLS

Coordinated and monitored Different Pharma Projects like sterile area facility, Anti biotic area,

Cephalosporin area, Water system, HVAC system, Ware house etc, Developing and Coordinating the

Project Time Lines, Expertise in management of product quality systems, training and implementation of

GLP, cGMP, GXP, and other guidelines FDA, WHO, PICS, PDA, ISO and ICH (documentation and lab

facility review, analytical / method development, chemistry, microbiology. Additional experience and

specialization includes information systems, regulatory affairs, development of IQ, OQ, and PQ protocols

for qualification and / or validation of analytical instruments; composed protocols, test scripts, work

instructions, and SOP documents. Recommended new equipment and/or more advanced technologies to

improve work flow.

Other included expertise, Validation Master Plan, Site Master File, Quality Manual and Policy, Analytical

Method Development and Validation, Cleaning Validation, Process Validation, Equipment (Lab and

Production) Validation and Calibration, Media Fill Trials, Controlled Area Validation, Validation of

Qualification of Steam Sterilizer, tunnel, SIP unit and, Depyrogenator and its cycle development, Water

system Validation (Pre-treatment Water, Purified Water and Water For Injection),Qualification of HVAC.,

Qualification of utilities, Air balancing, HEPA Filters integrity test, Generating User Requirement

Specification (URS),Generating and Conducting Factory Acceptance Test (FAT), Generating and

Conducting Site Acceptance Test (SAT), Ware House Qualification, Pure Steam Generator Qualification,

Inspection.

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Shahnawaz Sajid October 2009

New product development

Pre formulation studies, process optimization, risk based Process Evaluation reviews, Planning for new

launches, Development protocols and Pharmaceutics write ups including AMV protocols, technical

stability reports and other pertinent documents.

MANAGEMENT

• Prepare, write and review validation protocols and documentations to ensure compliance and

adherence to cGMP and GLP.

• Coordinated numerous types of validation of pharmaceutical process, products and equipments.

• Developed, analyzed, reviewed, and summarized cGMP technical / validation documentation, test

method data, changes to specifications, methods and tests.

• Coordinated and executed experiments / tasks to timely completion.

• Analyzed and trended data from a variety of sources. Ensured completion of all media fill

activities in connection with the production of pharmaceuticals produced in aseptic conditions

• Written media fill batch records and relevant reports; trends and tracks media fill and other results,

ensuring compliance with cGMP.

• Mentors others on: data analysis/ management’s skills, technical problem preventive / resolution,

design control procedures, investigation process and application of quality investigation for root

cause analysis and its impact on products.

• Developed validation protocols and related SOPs.

• Responsible for effective written, verbal, and interpersonal interactions with external clients and

internal project teams.

• Assisted staff in developing solutions to complex technical and regulatory problems and

investigation of unexpected results. Participated in client and regulatory audits of facilities and

quality system.

• Administered validation department and assured all operations are conducted in accordance with

regulatory requirements and expectations.

• Supported with the implementation of Six Sigma and Lean methodologies to improve business

processes.

• Worked with designing of experiment.

• HACCP (Hazard Analysis and Critical Control Points)

TRAINING AND CERTIFICATION

• “Bullet Proof Manager”’ conducted by Crestcom USA. 2009

• Performance Managenet System & Balance Score Card by NHR 2009

• 360 degree Feedback assessment by NHR 2009

• Certified for Validation and Qualification : Risk Based Approach (Techno solutions Co) 2008

• Certified for Validation and Project designing. 2007

Organized by Technology transfer, Inc. NJ, USA

• Training of Six sigma approach 2007

Organized by WHO consultant, Karachi, Pakistan

• Training of Hazard Analysis and Critical Control (HACCP)

Islamabad, Pakistan 2007

• New Method Development and Trouble shooting of HPLC 2006

Pakistan Pharmaceutical Educational Foundation, Pakistan

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Shahnawaz Sajid October 2009

SEMINARS AND PRESENTATION

• “Technology Transfer of Insulin” Crown Plaza July 2009. (Speaker)

• “Overview of Validation”, Who will get the last word seminar arranged by Ministry Of Health

Pakistan, Pakistan Pharma Expo 2008. (Speaker).

• “Validation week” arranged by Pharmaceutical Institute of GMPs, Chandigarh India, July 2008

(Attended).

• “Product Development and Validation”, Getz Pharma Pvt Ltd on 18th September 2007, Karachi

Pakistan. (Speaker)

• “Significance of Total Organic Carbon In Water For Injection and Cleaning Validation” Hilton

Pharma Pvt Ltd on 15th November 2006, Karachi Pakistan. (Speaker)

• “Welcome to the World of Safety” Hilton Pharma Pvt Ltd on 11 May 2006, Karachi Pakistan.

(Speaker)

• “New Method Development and Optimization by LC” Chemistry Department Karachi University

on 22nd August 2007. (Speaker)

• “Pharmaceutical Process Improvement” Pharmacy Department Karachi University on 9th October

2007. (Speaker)

• “Process Development and validation” by PPEF (Pakistan Pharmaceutical Educational

Foundation). (Attended)

• The European Directorate for the quality Medicine "A step forward towards the quality and

standard of medicine" By Pakistan Pharmaceutical Educational Foundation (PPEF), on 26th to 27th

Jan 2006, Karachi Pakistan. (Attended)

• “Process Validation, Drug Development and Quality Compliance” by PPEF (Pakistan

Pharmaceutical Educational Foundation), on 22nd – 23rd August 2005, Karachi Pakistan.

(Attended)

MEMBERSHIP AND AFFILIATION WITH PROFESSIONAL SOCIETIES

• Member of Chemical Society of Pakistan 2008

PUBLICATIONS

ACCEPTED

• Shahnawaz Sajid, Syed Shahid Ali, Najma Sultana and M. Saeed Arayne; Preliminary Evaluation:

The contamination of levofloxacin on other follow up drug products and cleaning validation of

equipment, in South African Journal of Pharmacy 2009 (In Press).

• Shahnawaz Sajid, Syed Shahid Ali, Najma Sultana and M. Saeed Arayne; Cleaning Validation of

Residual Ofloxacin on Manufacturing Equipment Surfaces, in PDA journal of Pharmaceutical

Science and Technology 2008.

• Shahnawaz Sajid, Syed Shahid Ali, S.Fatima Lakha; Review Article Validation and its overview

globally, Institute of Biopharmaceutical IBPA, January 2008.

• Shahnawaz Sajid, Syed Shahid Ali, Najma Sultana and M. Saeed Arayne; Validated HPLC–UV

method for simultaneous determination of olmesartan, irbesartan, telmisartan and candesartan with

combination of hydrochlorothiazide in pharmaceutical formulations and human serum, in Chinese

Journal of Chromatography.

• Shahnawaz Sajid, Guidelines, equipments and supplies for sterile compounding and

manufacturing, in askaboutvalidation forum, May 2008.

• Shahnawaz Sajid,Syed Shahid Ali, Najma Sultana and M. Saeed Arayne. Validated HPLC–UV

method for simultaneous determination of pravastatin, rosuvastatin, atorvastatin, lovastatin and

simvastatin in pharmaceutical formulations and human serum, Journal of Chemical Society of

Pakistan (JCSP) In Press.

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Shahnawaz Sajid October 2009

IN SUBMISSION

• Shahnawaz Sajid, Sterile area operators’ core training skill under peer review in International

Society of Pharmaceutical Engineering (ISPE).

• Shahnawaz Sajid, Syed Shahid Ali, Najma Sultana and M. Saeed Arayne. Development and

validation of stability indicating HPLC-UV method for the determination of leflunomide and its

metabolite A77 1726 in bulk materials and pharmaceutical formulation, under peer review in

Pakistan Journal Of Pharmaceutical Society.

IN PREPARATION

• Shahnawaz Sajid. Importance of Hazard Analysis and Critical Control Points in Pharmaceutical

Process. Askaboutvalidation.

Recent Project Details:

Project Objective: Aseptic area (Sterile area)

1.

Ø Reviewed and technical recommendations on building lay out, man, material and air flows.

Ø Developed and Coordinate the Project Time Lines.

Ø Assistance in equipment selection (Powder and Liquid washing, tunnel, filling and sealing lines,

autoclave, SIP, Ampoule filling machine etc)

Ø Developed User Requirement Specification (URS), FAT, SAT, IQ, OQ & PQ protocols of

equipments, HVAC, area and utilities)

Ø conduct Process capabilities studies (Six sigma)

Ø Conducted Media fill trials

Achievement

Successfully developed and executed first pre fabricated panel plant, which has capability to

manufacturing insulin, PPIs and several other injectables products.

Successfully passed zero growth media fill trials on three different lines.

Successfully approved by regulatory inspections.

Project Objective: Cephalosporin, Oral solid dosage form area, Antibiotic granule filling

2.

area, New Quality Control lab

Achievement

Enhance the productivity and reduces the production losses by implementing six sigma approach.

Coordinated and executed experiments / tasks to timely completion of above projects.

Project Objective: Qualification of Water, HVAC, Compressed air and Pure steam

3.

Ø Reviewed and technical recommendations on systems designing.

Ø Advised in purchasing of state of art equipment

Achievement

Successfully qualify utilities systems meeting international standards

Project Objective: Process, Cleaning and Analytical Method Validation

4.

Ø Initiate process, cleaning and analytical method validation

Achievement

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Shahnawaz Sajid October 2009

Activities going successfully according to international recognized standards (WHO, EU and US

FDA)

Project Objective: Quality Risk management and process improvement

5.

Ø Introduced and executed the concept of ICH Q9 Quality Risk Management and six sigma

ap p r o ach

Achievement

By applying theses critical systems, Productivity level increased with reduced loses and achieved Cpk

and Ppk values on manufacturing processes. Evaluated risk severity concepts and prioritised activities

based on it.

Project Objective: Technology Transfer and Site Qualification from Eisai Pharmaceutical,

6.

Japan.

Ø Site qualification established for manufacturing process, analytical technique and stability of

under licence product from Eisai Pharmaceutical Japan.

Achievement

All operations and documentations were successfully inspected and audited by Eisai Pharmaceutical

Experts and granted the license for local manufacturing.

Project Objective: New Product Development - System designing

7.

Ø Implemented the System as per ICH Q8.

Achievement

Introduced Development protocol, Development Pharmaceutics and other pertinent documents to

satisfy the basic requirements of regulated and semi regulated markets.

References Available upon Request

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