Contact

ZOHAIB NAQVI

14, Brook Wood Drive, Richmond Hill, ON.

L4S1E8
(416) 371-9418
syedpost@gmail.com

Validation Specialist

Professional Summary
Over four years of experience in validation compliance of pharmaceutical manufacturing and research
facility.
Well- versed with software life-cycle methodologies with emphasis on quality assurance and testing
practices.
Managed validation / compliance of Cephalosporin drug manufacturing facility. (New Project).
Possess excellent communication, analytical, organizational and presentation skills.
Deeply involved in writing, prioritizing and executing Validation Master Plans and related activities.
Project-oriented skills, with the ability to work on more than one project at a time.
Deeply involved in writing, prioritizing and entertaining Change Control Requests.
Owned Impact Matrix and provided regular updates to Higher Management.
Experienced in Business Process Modeling, Process Improvement and Process Reengineering.
Involved in designing the Technical Design Document for the Workflow development process which
play a critical part in the success of the system.
Experienced in managing QA/QC resources, UAT testing, end user training and support.
Experience in planning, co-coordinating and performing Manual Testing, Functional Testing,
Validation, Testing, Migration Testing, User Acceptance Testing (UAT), End to End Testing, White Box
Testing and Black Box Testing of large-scale applications with multiple interfaces.
Have good knowledge and work experience on production support for new projects.
A good team player, a quick learner and an effective communicator.

Key Skills
Operating Systems

Linux, Unix, Windows9x, XP, Vista, Windows 7.

Languages

C, C++, VB.Net, C#.

Databases

MSSQL, DB2, Oracle.

Tools and Utilities

MS Office, Ms Project, Illustrator, Photoshop, Macromedia, MS Visio.

Work Experience
Brookes Pharma (Pvt.) Ltd-Karachi, Pakistan

June 2010 July 2013

Associate Manager Validation

Prepared / Revised Master Validation Plan.
Prepared / Revised Computer Validation Plan.
Performed and documented validation gap analysis.
Prepared, reviewed, executed and summarized validation protocols (IQ, OQ, PQ, PV and CV) for
following validation and qualification exercises.
Process Validation
Facilities and Utilities Qualification
Equipment Qualification
Computer Validation Sterilization Process Validation
Design Qualification.
Cleaning Validation
Executed and documented validation Plans and Protocols (Tests) to comply with applicable
regulations as per GAMP and cGMP.
Served as a technical resource and subject matter expert on FDA and GAMP regulations for
assessing validation requirements for solving test related problems and compliance.
Assured 21CFRPart 11 / EU annexure 11 compliance.
Collaborated and interacted with individuals from different disciples (IT, Engineering,
Manufacturing, Quality Assurance, Business and vendors) to plan, execute and complete validation
activities.

Intel Pakistan Corporation-Karachi, Pakistan

Channel Executive

Aug 2007 May 2010

Primarily responsible for Sales in Karachi.

Catering to over 200 Channel Partners.
Coordinating in Warranty Support and different channel related issues.
Executing plans for new sales promotions.
Key Role player in ICC (Intel Channel Conferences) South.
Managing some most potential Corporate Customers.
Coordinating with a team of retail executives.

H.E.J Research Institute-Karachi, Pakistan

Jun 2006 Jul 2007

Project Assistant
Worked as a Project assistant on the L.E.J. Digital Library & H.E.J. library web portal.
Developed standards and operational procedures for analytical equipments.
Validated the hardware lifecycle by Development and execution of Protocols and quality risk
assessments.
Prepared, reviewed, executed and summarized validation protocols (IQ, OQ, PQ, PV and CV) for
validation and qualification exercises for autoclaves and other analytical equipments.
Executed and planned yearly qualification exercises.
Assisted the QA & UAT testing teams to write test scripts and coordinate testing.
Responsible for Change Control and end user acceptance to change.
Initiated, executed, and tracked completion of Change Control requests related to processes and
equipments.
Worked on a project planning of First Incubator Research Park in Pakistan.

Technology Concepts, Pakistan

Nov 2005 May 2006

Technical Associate

Administered ERP (scala) and Intex (ERP for textile industries) marketing and technical support staff.

Worked on maintaining day-to-day selling charge sheet of sales representatives and maintaining their
monthly dividends.

Worked on requirement gathering and project documentation and implementing it according to the
SOPs.

Trained the individuals to get maximum throughput out of the software and hardware installed.

Ensured process software lifecycle is fully followed and documented.

Provided a liaison between different stakeholders and assisted the QA & UAT testing teams to write
test scripts and coordinate testing.

Education
Bachelors in Science
Majors Computer Science.
University Of Karachi, Pakistan.
References
Available upon request