Quality Control Manager

CURICULUM VITAE

Name: Muhammad Yousuf Qureshi

Father’s name: Muhammad Anwar Qureshi

N.I.C. No.: 42301-7728625-9

Residential Address: House # No.3, Street No.18 River Garden Islamabad

Birth Place Khanewal Punjab

Contact No.: 031********

E-mail: ***********@*****.***

Qualification: MSc. (Analytical Chemistry)

Karachi University

Diploma: of 6 months in English Language from

National University of Modern Languages

Karachi.

JLC: 2 years Japanese Language Course from

Japan Cultural Centre Karachi (1981-1983)

in connection with taking scholarship from

AOTS Japan

Working Experience: Almost more than 27 years

OBJECTIVE

As being an innovative mind and keen to face challenges, I want a Management Position in an Organization, where I can express and utilize my innovative skills and maximum potential to maintain and improve the productivity and standards in the applied capacity. TECHNICAL EXPERIENCE

Worked as:

1-. In charge Analyst of Quality Control

At Macter International

Almost 4 years 2 months and 10 days

2-. Head of Quality Control Operations, Plant Manager & Management Representative At Semos Pharmaceuticals (Pvt.) Ltd.

Almost 9 years

3-. Quality Control Manager & Quality Operation Manager At Epoch Pharmaceuticals (Pvt.) Ltd

Almost 4 years

4. Quality Control Manager

At Regent Laboratories (Pvt.) Ltd

Almost 7 years 3 months and 16 days

5.Quality Assurance Manager & Quality Control Manager At Silver Surgical Complex

Almost 5 months

6.Quality Assurance Manager & Quality Control Manager At Nawan Laboratories (Pvt.) Ltd

Almost 7 months and 18 days

7. Plant Manager

At Zanctok Pharmaceutical Laboratories.

Almost 5 months

8. Quality Control /Assurance /Regulatory Manager

Mediate Pharmaceuticals

Almost 3 years

9. Quality Operation Manager

At Palpex Pharmaceuticals

Almost 3 years

10. Quality Control Manager

At Norwich Pharmaceuticals in Model town Humak Islamabad Almost 3 years & seven monhts

11.Quality Control Manager

At Norwich Pharmaceuticals in Model town Humak Islamabad Almost 3 years & seven monhts

12 Quality Control Manager

At a newly Established & Licensed Pharmaceuticals in Industrial Estate Rawat Islamabad Currently working from 15th June 2023

Job Description

Working of CTD Dossiers & Form 5 for Local & Export registration (36 dossiers have been submitted through e-Application of DRAP out of 36, 8 dossiers Approved & Registered Working as an Additional Care Taker Plant Manager or GM Operation To supervise, coordinate and direct quality control function of the company covering areas like QC conformance of incoming material and finished products through established processes. Lead a highly specialized position with a plethora of challenges. Main task is to develop and implement long-term quality strategy. Identifies quality gaps, implement reporting processes in order to track quality improvements, enhance current systems, define and prioritize high-value quality projects and manages projects to completion. Develop standardized testing methods, which facilitate the quality checking process. Put the results of quality analysis in reports to present them to senior management. MAIN JOB RESPONSIBILITIES

Quality Control

Incoming materials:

Approval & testing of all incoming components / packing material / raw materials in accordance to the quality standards & policy followed by the company. Rejections if any, to be finalized supporting valid reasons, after discussion with management.

Approval & testing of material consignments from vendors. Approval under Deviation On careful consideration of possible impacts on the business & analyzing the total situation on briefing & further discussion with management. To communicate effectively with suppliers in case of any discrepancies of incoming materials in consultation with the management. Convince and take agreement from the supplier for ownership of rejection /replacement and ensure future Quality supply. To pursue with the suppliers and ensure that credit notes/ replacements are received in timely manner for incoming material rejections.

To change & upgrade approved standard samples of materials (Once in six months). To maintain & update the list of compounds for category of testing. Functional support:

Distribution:

Preparation of technical certificates & material safety data sheets (MSDS) as per the requirement of customers from various countries to meet their local regulatory compliances. Providing answers on technical queries raised by individual customers. DRAP

Preparation of technical certificates as per the requirement of testing laboratory to comply initial registration requirement for DRAP.

To provide technical inputs and suggest on various options to enable registration of products DRAP in order to meet local regulatory compliance.

Procurement:

Evaluation & approval of pre-production samples of new samples as well raw /packaging material/ trading items from new sources. Ensure timely feedback on the same. R&D

Testing and sensory evaluation of new medicinal samples. Analysis of trend of deviation and initiating corrective action Preparation of product certificates

To compare new artworks with the checklists provided by R&D and confirm approval or provide feedback on the observations

Regulatory Dept.:

Product registration:

1. To select product, prepare the requisite documentation label assessment form, analytical certificate, prior communication to DM and handover the product for submission to authorities. Have an extensive knowledge of regulatory requirements, an understanding of current global, regional and national trends in Regulatory Affairs and ability to assess the impact of these requirements Capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities

Responsible for leading all regulatory activities for assigned projects and territories. Have a minimum of 29 years of relevant experience in regulatory affairs. Able to demonstrate previous experience of people management and direct experience working with Regulatory Authorities.

Excellent verbal, written, negotiation and interpersonal communication skills Team Management & People Development:

Following up on members QC tasks

Managing, Training and Developing the Team Members Conduct quality related training to all quality control staff to develop and monitor them. Track the performance of the team members / subordinates.

Development of Quality Champions in Production department Complaints & Quality Issues

solely responsible for setting quality standards, maintaining and improving them. Monitoring day-to-day quality issues and ensuring compensation (credit notes) from suppliers with respect to supply for any online damage / extra manpower utilized in consultation with the management.

Provide quick feedback to distribution & Retail on Quality issues. Handling market complaints for product returns from outlets & customers. Investigate the root cause in consultation with production and ensure measures of prevention. Documentation

Preparing & updating Quality policy manual covering all procedures and controls. Oversee record keeping documentation related to quality control information & customer complaints. Certification

Conduct audit for compliance to GMP standards.

Responsible for GMP certification / recertification and complying with GMP practices. Ensure SASO compliance

ISO certification / recertification

Samples & Testing Equipment:

Upkeep of testing equipment

Responsible for purchasing of modern equipment

Maintenance of library for samples

General:

Assure the calibration and maintaining the testing equipment, solutions and materials for tests, as per the Quality Manual Procedures and Frequency.

Cross-Checking and tracking the quality control processes Active participation in product valuation exercises. Participate in supplier meetings/ exhibitions.

Cooperate with the production line managers to plan an effective and achievable production schedule on daily wise.

Preparation of MIS reports for quality assurance department KEY JOB DELIVERABLES / ACCOUNTABILITY

Setting objectives for quality compliance to achieve targets Quality conformance of all incoming materials and Finished Product Effective vendor communication & ensure timely credit notes for rejections Support R&D for new product launches by issuing product certifications Finished products registration with govt. authorities for statutory compliances Setting quality standards, maintaining and improving them. ISO & GMP certification / recertification

Quality policy manual and procedures.

Process improvement

To supervise, coordinate and direct quality control function of the company covering areas like QC conformance of incoming material and finished products through established processes. Lead a highly specialized position with a plethora of challenges. Main task is to develop and implement long-term quality strategy. Identifies quality gaps, implement reporting processes in order to track quality improvements, enhance current systems, define and prioritize high-value quality projects and manages projects to completion. Develop standardized testing methods, which facilitate the quality checking process. Put the results of quality analysis in reports to present them to senior management. Knowledge:

Strong technical & analytical knowledge

QA systems implementation

Knowledge of product statutory requirements

Knowledge of preparation of technical documents

Excellent knowledge of the automated testing requirements techniques Excellent product domain knowledge

Thorough knowledge of departmental quality control policies Skills/ Abilities :

Resource Management

Leadership & People Management

Communication Verbal & written

Ability to interpret laws, rules and regulations

Ability to conduct investigative interviews

Ability to develop and implement policies and procedures for quality control review Experts of all types of CTD registration Dossiers for local and foreign countries Reports to : Director

Supervises : Assistant QC Manager & Team

Liaise with : Internally Production, R&D, Warehouse, Distribution & Procurement Externally - Suppliers, Govt. Authorities, Business associates References:

May be furnished on request

Languages: Punjabi, Sindhi, Urdu, English & Japanese Training & Certifications;

ISO 9001 & ISO 14000

DML Certifications:

Semos Pharmaceuticals

Epoch Pharmaceuticals

Regent Laboratories

Silver Surgical Complex

Nawan Laboratories

Mediates Pharmaceuticals

Palpex Pharmaceuticals

Norwich Pharmaceuticals

New Pharmaceuticals

Contact this candidate