The document is a curriculum vitae for Dr. Zakia Saeed, who has over 15 years of experience in pharmaceutical quality control, quality assurance, and regulatory affairs. She holds a PhD and MPhil in Pharmaceutical Chemistry from Karachi University. Her experience includes positions as Quality Control & Quality Assurance Manager at C.K.D Pharmaceuticals Pakistan and Senior Manager of Quality Assurance & Regulatory Affairs at Medisure Laboratories Pakistan, where she oversaw quality management, inspections, and regulatory compliance. She is skilled in methods validation, documentation, auditing, and ensuring compliance with cGMP standards.

1. 1
Curriculum Vitae
Accomplished Pharmaceutical Chemist hosted PhD & M.Phil in Pharmaceutical Chemistry from
Karachi University, diversified experience of QC, QA and Regulatory Affairs, cGMP, Method
Validation, have devised several novel methods on HPLC with multiple research publications in
international journals and Certificate Courses on different topics related to pharmaceutical with
strong scientific, analytical, statistical, planning, managerial and training skills.
I am confident, ambitious, have good initiative drive, self motivated, cooperative, polite, and
energetic and problem solving skills with excellent communication, managerial & presentation skills
and aimed at performing in an effective and efficient manner at each level in the organization.
1. Experience.
Quality Control & Quality Assurance Manager:
C.K.D Pharmaceuticals Pakistan (Pvt) Ltd:
Feb 2016 – Present.
 Draft quality assurance policies and procedures.
 Interpret and implement quality assurance standards.
 Evaluate adequacy of quality assurance standards.
 Devise sampling procedures and directions for recording and reporting quality data.
 Review the implementation and efficiency of quality and inspection systems.
 Plan, conduct and monitor testing and inspection of materials and products to ensure
finished product quality.
 Document internal audits and other quality assurance activities.
 Investigate customer complaints and non-conformance issues.
 Analyze data to identify areas for improvement in the quality system.
 Develop, recommend and monitor corrective and preventive actions.
 Prepare reports to communicate outcomes of quality activities.
 Identify training needs and organize training interventions to meet quality standards.
 Coordinate and support on-site audits conducted by external providers.
 Evaluate audit findings and implement appropriate corrective actions.
 Responsible for document management systems.
 Assure ongoing compliance with quality and industry regulatory requirements.
 Manage and oversee project quality to ensure compliance to codes, standards,
regulations, equipment specific specifications, and QMS requirements.
 Advancing quality achievement and performance improvement throughout the
organization.
 Manage all possible documents for regularity purpose.

2. 2
Senior Manager Quality Assurance & Regularity Affaires:
Medisure Laboratories Pakistan (Pvt) Ltd:
Oct 2013 to Nov 2015.
 To make arrangements for Raw material, packaging material and finish product testing.
 To assure the good manufacturing practice are observed during all manufacturing and
packing.
 To ascertain the schedule for product stability studies and testing of retention samples.
 To make and check art works of new and already existing products.
 To communicate problems to the suppliers and solve them.
 To check art works of marketing literature of all products.
 To assure that good lab practices are observed during all testing.
 To monitor and arrange training of sub-ordinates.
 Work on Quality Management System, Laboratory Information Management System,
Supplier Quality Management & development, Validations, Stability, Customer
Complaints/Change Control, Batch Release, Quality Systems Audits, a Certified Trainer/,
Operational and Regulatory compliance in Pharmaceutical Industry.
 Develop and analyze statistical data and product specifications to determine standards
and to establish quality and reliability expectancy of finished products.
 Provide, and oversee, inspection activity for product throughout production cycle.
 Apply total quality management tools and approaches to analytical and reporting
processes.
 To manage the regulatory department and develop processes so that new chemical
entities, new dosage forms and new indications are registered in a timely fashion.
 Ensuring that a company's products comply with the regulations of the MHRA.
 Keeping up to date with international legislation, guidelines and customer practices in all
countries that the company is exporting.
 Developing and writing clear arguments and explanations for new product licenses and license
renewals.
 Preparing submissions of license variations and renewals to strict deadlines.
 Writing clear, accessible product labels and patient information leaflets.
 Advising scientists and manufacturers on regulatory requirements.
 Project managing teams of colleagues involved with the development of new products.
 Undertaking and managing regulatory inspections.
 Prepared ACTD dossier for all dosage.

3. 3
Q.C/QA Executive:
Zafa Pharmaceutical Laboratories Pakistan (Pvt) Ltd:
Jan 2007 to Oct 2013.
 Testing of APIs, intermediates, finished products and stability samples on HPLC, FTIR,
UV/Visible Spectrophotometer & GC.
 Sampling of raw materials intermediates and finished products
In-process control of production.
 Preparation of SOP.
 Manage external audits.
 Work on product method validation.
Q.C/QA Executive:
Alina Combine Pharmaceutical (Pvt) Ltd:
July 2003 to Dec 2006.
 Testing of APIs, intermediates, finished products and stability samples on HPLC, FTIR &
UV/Visible Spectrophotometer GC.
 Sampling of raw materials intermediates and finished products
In-process control of production.
 Preparation of SOP.
 Manage workers training.
 Maintain Quality Control record.
 Discuss inspection results with those responsible for products, and recommend necessary
corrective actions.
 Discard or reject products, materials, and equipment not meeting specifications.
 Inspect, test,and sample materials or assembled parts or products for defects and deviations
from specifications.
 Observe and monitor production operations and equipment to ensure conformance to
specifications and make or order necessary process or assembly adjustments.
Personal Information:
Name: Dr. Zakia Saeed (PhD)
Father’s Name Abdul Samad Khan
Date of Birth 20.04.1977
Religion: Islam
Nationality: Pakistani
N.I.C. No: 42201-0381513-2
Contact No: 03310348203, 03012600627.
Address: Flat # D –18, 3rd
Floor Block 06 Street Momin Squire
Gulshan Iqbal Karachi East.
E-mail: zakiachemist@gmail.com