Muhammad Yousuf Jamal Khan
Quality Assurance Specialist
Karachi
Summary
A dedicated and detail-oriented Quality Assurance specialist with 8 years of experience in ensuring the quality and compliance of products through sound skills on Quality management systems.
Overview
2025
2025
years of professional experience
18
18
years of post-secondary education
1
1
Certification
Work History
Assistant Manager OQ & Deviation Lead
GSK Glaxo Smith Kline
Karachi
07.2022 - Current
- Assess the unexpected condition, classify the deviation, describe the level of investigation required and perform investigation with relevant team for identification of root cause & CAPA and to ensure that all investigations are completed within 30 days. Completion of investigation within 30 days. Conduct periodic reviews of deviations for SQC meeting.
- Address quality and compliance issues and continuously improve operations by identifying, recording and implementing Corrective and Preventive Actions (CAPA). Define the CAPA Plan and track CAPA actions to ensure the compliance and to avoid any overdue.
- Determine the CAPA Effectiveness Requirements and verify the CAPAs for its effectiveness. Approve the final CAPA closure by checking the evidence provided to prove the CAPA is in place and confirming that the requirements for any independent CAPA effectiveness checks are complete.
- Periodic review of deviations for adverse trend and CAPA effectiveness.
- Review deviation metrics and trends and take action to address significant issues.
- Determine if the deviation meets any criteria for escalation to a Local Incident Committee (LIC) or Product Incident Review Committee (PIRC). If so, escalate.
- Providing weekly and monthly reports and compiling Site monthly report and Zero defects Quality metrics data.
- Management of Customer Complaints and KPIs of Customer complaints.
Quality Management System Lead & Assistant Manager Validation
GLAXOSMITHKLIEN PAKISTAN LIMITED
Karachi
3 2022 - 06.2022
- Escalation of significant QMS risk & issues related to QMS Implementation & any failures to meet
- Ensure that the GAP session has been conducted for each new & revised QMS release
- Make sure that the Annual review for effectiveness of QMS implementation must be done for action plans to Site Quality Council
- Prepare and ensure all facilities, equipment and operations at site are validated (URS, DQ, IQ, OQ, PQ) in line with the regulatory and corporate requirements
- Working in cross-functional teams responsible for process improvement and process compliance; bringing the regulatory and corporate perspective of validation and systems applications to the GMS
- Ensure and support the validation team party in achieving validation targets as per defined timelines
- Ensure the SVMPs and VMPs is in place in compliance with the GQPs, GQMPs and regulatory requirements
- Prepare and ensure to maintain SVMPs and VMPs as appropriate for new projects such as update of facilities, systems, and new product introduction at Site
- Prepare and ensure that the Validation Summary Reports must be prepared on time to meet customer and release deadlines
- Ensure and coordinate that cleaning validation & verification activities will be carried out timely with all related documents in place
- Ensure the periodically reviews of validated manufacturing and filling processes, equipment, utilities, facilities, cleaning processes in order to ensure that they remain in validated status
SITE Change Control & Data Integrity Lead
GLAXOSMITHKLIEN PAKISTAN LIMITED
04.2021 - 03.2022
- Governance of Data integrity guidelines in all value streams
- Governance of change management system in QWF
- Implementation of Data integrity assessments as per relevant procedures
- Conduction of DI and change control capability drives and learning sessions
- Governance of Actions of Change control through QWF
- Management of DI alerts
- Annual review for the effectiveness of system
- Management monitoring of DI and change control system
QA In-process Monitor
PFIZER PAKISTAN LIMITED
12.2015 - 04.2021
- Implementation of CGMP Guidelines as per PQS on Entire Primary and Secondary area of production
- Planning and organizing the product release activity to meet the market requirement
- Coordination and consulting with all the stakeholders for timely release of product
- Auditing and record keeping batch history records
- Batch release activity in EnterpriseOne system
- Facilitating in process validation and packaging validation activities
- On time Incident reporting (event and deviations) and conducting investigation using Method 1 and PHP tools for root cause analysis
- Work on CAPA tracking module
- Performing In-Process line Checks on Entire Production Area
- Sampling of Products on Bulk and Finished goods stage
- Documentation of daily In Process Checks
- Management of Reference samples and Record room
Technical Quality Assurance Officer
Dalda Foods Pvt Limited
08.2014 - 09.2015
- Performed Process lab work for Edible Performing Process Oil Process Services in Dalda Foods
- Testing of Bulk and finished samples as per relevant test procedures
- In-process of packing line and oversight the processing operation
- Worked in SAP for Production Posting and QA Clearance
- Worked as Production Officer for Dalda Cooking Oil Pouch Section
- Packing Line checked work for Entire Production
Education
Masters of Analytical Chemistry -
University Of Karachi
01.2014 - 12.2014
BSc Hons. Chemistry - undefined
University Of Karachi
01.2011 - 12.2013
Intermediate (Pre-Medical) - undefined
Government College for Men
03.2007 - 12.2009
Matriculation - undefined
Modern Public Sec. School
01.1999 - 03.2007
Hafiz-ul-Quran Degree - undefined
Wafaq-ul-Madaris
03.2000 - 09.2003
Skills
Management
Ability to deal with all levels of staff
Ability to work under pressure
Multidimensional thinking
Leadership skills
Good communicator
Quick learner
Personal Information
Date of Birth: 12/27/91
Certification
Orange belt certification
Timeline
Orange belt certification
03-2024
Assistant Manager OQ & Deviation Lead
GSK Glaxo Smith Kline
07.2022 - Current
SITE Change Control & Data Integrity Lead
GLAXOSMITHKLIEN PAKISTAN LIMITED
04.2021 - 03.2022
QA In-process Monitor
PFIZER PAKISTAN LIMITED
12.2015 - 04.2021
Technical Quality Assurance Officer
Dalda Foods Pvt Limited
08.2014 - 09.2015
Masters of Analytical Chemistry -
University Of Karachi
01.2014 - 12.2014
BSc Hons. Chemistry - undefined
University Of Karachi
01.2011 - 12.2013
Intermediate (Pre-Medical) - undefined
Government College for Men
03.2007 - 12.2009
Hafiz-ul-Quran Degree - undefined
Wafaq-ul-Madaris
03.2000 - 09.2003
Matriculation - undefined
Modern Public Sec. School
01.1999 - 03.2007
Quality Management System Lead & Assistant Manager Validation
GLAXOSMITHKLIEN PAKISTAN LIMITED
3 2022 - 06.2022
Similar Profiles
Corinne SchaliCorinne Schali
Respiratory Sales Specialist at GSK Glaxo Smith KlineRespiratory Sales Specialist at GSK Glaxo Smith Kline
Nicole GoedtelNicole Goedtel
Adult Immunization Specialist at GSK Glaxo Smith KlineAdult Immunization Specialist at GSK Glaxo Smith Kline
April KratkyApril Kratky
Senior Account Specialist USC Specialty at GSK Glaxo Smith KlineSenior Account Specialist USC Specialty at GSK Glaxo Smith Kline