SYED ANWAR KAMAL
**************@*******.*** +966-********* Jeddah, KSA
SUMMARY Quality Manager with over 27 years of diverse experience exclusively from the pharmaceutical industry covering both aspects of business, i.e. manufacturing site and commercial business. Expertise in leading and managing all the current Quality Management System, Internal / external (Distributors and 3PL) audits, Validation / Qualification of Warehouses and Vehicles, Distribution Risk Assessment (DRAs), Deviations, Change Controls, Product Complaints, Quality Agreement / Technical Terms of Supply Agreement (IQAs/TTs), Local Incident Committee and Recalls (LICs / PIRCs), CAPAs, (Quality Work Flow /ERP / SAP system - Track-wise and Veeva system), and other related activities for the manufactured and supplied Pharma and Vaccine products. Capable of working independently and creatively to execute high-pressure jobs timely and professionally while actively identifying issues and developing resolution plans. As a reliable, meticulous, hardworking and motivated person, I also have excellent organisational, communication and interpersonal skills, with a strong focus on execution. I align myself in accordance with organization’s vision and values and strategic priorities and expectations.
Currently working in GlaxoSmithKline Saudi Arabia as a LOC Quality Manager. KEY SKILLS
• Quality Management System implementation.
• Veeva System / CARISMA/QWF system
• SAP / One ERP system
• cDMS system handling of Technical Documents
• cGMP, HS&E requirements understanding.
• Leadership
• Project management
• Develop strategic plans.
• Interpersonal and Communication
• Critical thinking
EDUCATION
• Bachelor’s degree in science from Karachi University, Pakistan
• Professional degree, Bachelor of Laws (L.L.B) from Karachi University, Pakistan
• GSK Certified Pharmaceutical Lead Auditor since 2008, with recertification every three years. Trainings Completed:
• Leadership Skills Training Program
• Time & Performance Management
• Professional Supervisor Training Course
• QEHS Internal Auditing & Audit Disclosure
• OHSAS Awareness and Understanding
• Living the GSK Spirit.
These certifications reflect my dedication to maintaining the highest standards in quality assurance, process improvement, and compliance with international best practices and regulatory requirements. Page 2 of 6
My extensive career has been defined by a steadfast commitment to ensuring product integrity, patient safety, and adherence to global regulatory standards.
WORK EXPERIENCES LOC Quality Manager April 2014 – Present
GSK Saudi Arabia
Regional Quality PSM MEA Senior Director - Primary & Small Molecule Quality Quality Management System:
• Manage and perform all the current Quality related activities for the manufactured and supplied Pharma and Vaccine products received from different GSK sites and CMOs.
• Manage all current QMS events such as Deviations, Change Controls, Products Complaints, CAPA implementations, etc.
• Managing the Risk Management System (RMS / Veeva System ) for the identified Quality department risks, creation of mitigation plan that are SMART (Specific, Measurable, Aligned, Realistic and Time-bound).
• Conduct and Chair Local Incident Committee (LICs), participate in Group Product Incident Review Committee (PIRCs) and Recalls (In addition, participate as Recall Secretary in assigned PIRCs). Responsible as Recall coordinator and management of GSK PRS system for LICs & PIRCs.
• KPI and metrics reporting to Regional Quality periodically for QMS implementation as per specified schedule, to ensure all compliance processes are effective to monitor and review the performance measures that drives for improvement.
• Handing of Power BI process for KPI updates for different Quality related activities
• Convene and Chair Quality Council meeting for GSK Saudi Arabia.
• Participated and worked in GCC Quality Council and Quality related updates since 2017 May to 2023 June.
• Accountable for Quality Regulatory Intelligence (QRI) to ensure they are appropriately managed its applicability as per QRI and Veeva process requirements.
• Participate and review of Annual Management Review of QMS activities and deliverables for GSK Saudi Arabia level.
• Participated and review of Annual Management Review of QMS activities and deliverables for GSK Saudi Arabia and also worked with GCC (Gulf & Saudi) level during cluster process of GCC from 2017 May to 2023 June.
• Coordinate and manage Quality Plan for GSK Saudi Arabia and compile inputs from other Quality Team members. Accordingly create annual Quality Action Plan for implantation and closure of actions. Also participated as GCC region from 2017 May to 2023 June.
• Follow and manage of document retention as per GSK record retention Policy.
• Responsible and accountable for the release of batches for pharmaceutical and Vaccine products while ensuring to review and confirm that product’s integrity and patient safety is maintained through the shelf life of product and that it is suitable for release before distribution into the market. Audits & CAPAs / QWF (Track-Wise) currently in GSK Veeva QMS System
• Internal Management Audits (MM audits & IBM audits) / External audits for Distributors, Third-Party (3PL) warehouse and Third-party transporter for Pharma and cold chain (Audit plan, conduct, reporting and CAPA management for the identified gaps). Ensure that pharma and cold chain process is followed for storage, handling, and distribution as per GSK standard and Saudi regulatory requirement.
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• Manage and supervise all CAPAs / Actions items from MM (L1) / IBM (L2), External supply Quality (ESQ) audits, Deviations / RCA, Change Controls, Quality Alerts, QMS reviews (PGSOPs / GQSOPs / IATs) and long-term actions from LICs and PIRCs, etc, are tracked through current Veeva System and previously done for Quality Workflow (QWF) – Track- wise.
Internal Quality Agreements (IQA / TTS) / Quality Agreements & DRAs
• Manage and approve GSK products Internal Quality Agreements (IQA) / Technical Terms of Supply (TTS) and Quality Agreements for the supplied products from other GSK sites / CMOs and ensure that products are marketed with the registered specification and comply with the Saudi Arabia Regulatory Authority requirements.
• Review and approve Distribution Risk Assessment (DRAs) for Pharma and Vaccine products supplied to the market and received from different GSK sites / CMOs as finished products. Product Complaints
• Manage Product Complaints at Saudi Arabia level and ensure all complaints are recorded, investigated and appropriate CAPA is taken and communicate to complainant with the outcome of investigation. Currently Complaints are managing through Veeva System in Saudi Arabia. Worked at GCC (Gulf & Saudi) level during cluster process of GCC from 2017 May to 2023 June.
Third-party (Distributor and 3PL)
• Oversee and approve Third-Party (3PL) and distributors for warehousing, distribution / transportation to ensure products integrity is maintained through warehouse management process, qualifications, temperature mapping & monitoring process and calibration of devices.
• Supervise and manage Quality KPI review with Distributors and Third-party service provider.
• Manage and approve Quality Agreements with Distributors and Third-Party (3PL) including Audit process.
• Supervise to manage temperature excursions incidents during supply chain of GSK products and release / approve for further distribution to market and ensure that product quality, patient safety is to be maintained throughout the product shelf life.
• Manage Repacking activities at GSAL site Jeddah, and repacking stickering process at Distributor and Third-party (3PL) warehouse with all QA related process requirement.
• Train Distributors and 3PL on current QMS requirements such as handling of complaints, Pharma & Cold chain management, GMP/GDP, Deviations, Repacking, Aggregation and Handling of Temperature excursions. ACHIEVEMENTS:
• QMS Implementation : Developed robust Quality Management System, provided awareness, and build Quality Culture within the Site and Commercial Organization to ensure all the quality related activities are performed as per GSK current standard and local regulatory requirements.
• Trade Route Change : Involved in Trade Route Change Project (RTM) for the change of Saudi entity from Distributor to Glaxo Saudi Arabia and successfully completed. .
• One ERP / SAP System : Performed role as a super user in One ERP implementation project with respect to all Quality related activities and successfully implemented.
• PIRC & Recalls: Participate as Recall coordinator and Recall Secretary in assigned PIRCs .
• Veeva System : Involved in the project of implementation of Veeva System and implemented successfully (i.e., currently in-place and in-use)
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Risk and Compliance Supervisor (LOC) Jan 2012 – March 2014 GSK Saudi Arabia
• Managed and performed all the current Quality related activities for the manufactured and supplied Pharma and Vaccine products received from GSK sites.
• Manage and approve the GSK products for DRAs, TTS and Quality Agreements to ensure that registered products are comply as per MOH requirements.
• Lead and manage the Management Monitoring (MM and IBM) Audits within the organization.
• Manage commercial compliance, periodic reviews /backend monitoring of various LOC functions and Quality Audits.
• Lead and developed all Quality related procedures and audit process.
• Lead, manage and conduct audits of Distributors with the CAPA plan and its closures including QMS / GDP trainings.
• Chair and convene Quality Council meetings, presentations with all Quality related updates.
• Present in Risk Management and Compliance Board (RMCB) meeting for Quality updates, Risk Management Process, and organization Commercial compliance.
ACHIEVEMENTS
• Developed and lead audit process, SOPs, and all quality events such as deviations, change control, customer complaints, CAPA implementations.
• Built relationship, awareness, and Quality Culture within the Commercial Organization to ensure, understanding and improve implementation of QMS.
• Lead and managed the Risk Management Process / Register within the organization.
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Quality Compliance Section Supervisor Dec 2000 – Dec 2011 GSK Saudi Arabia Ltd.
The following Quality Compliance staff were my direct reports with different Quality Compliance responsibilities:
• Quality Compliance Officer, responsible for documentation and Document Management System for handling and update in the DMS system for all the GSAL site Standard Operating Procedures.
• Quality Compliance staff / Officer, responsible for the review of Batch dossiers before final review and approval.
• Quality Compliance staff / Officer, responsible for the Sampling of Raw materials and archiving of batch documents, retained samples of finished packs and raw materials. RESPONSIBILITIES
• Ensure Quality Compliance system on site complies with the GSK QMS requirements as per GSK group polices, CAPAs and all related regulatory guidelines.
• Review of manufactured batch dossier record of each product manufactured by Glaxo Saudi Arabia prior to release of the products to market.
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• Review and regulatory check of Batch Manufacturing Instruction and Batch Packing Instructions of all products pertaining to the production.
• Review and approve all Quality Critical / local standard Operating Procedures as management representative prior to final authorisation by Site Director.
• Involve and maintain the KPI data to ensure all the compliance processes are effective and drive for improvement to monitor and review the performance measures.
• Supervise and manage “Document Management System” archiving area to archive all Quality Technical documents, Manufactured Batch documents, retained samples for Raw materials and finished pack products.
• Supervise and manage record retention at GSAL site as per GSK record retention Policy.
• Supervise & manage “Not Right First Time” (NRFT) batch documents related to production and issuance of NRFT results/trends. Present the NRFT data in the monthly “Quality Review / Council Meeting” along with highlighting the anomalies pertaining to production to minimise the errors and to improve the RFT results of Manufacturing and Packing of products.
• Assisting other Senior Managers / Director of site with quality related expertise as and when required and for the inspection readiness at site. Escalate any issues which can impact the inspection readiness.
• Involve and support EHS to ensure Quality Compliance and EHS risks are identified and communicated to log in Risk register for mitigation accordingly.
Audits & CAPAs
• Conduct internal quality IBM (L2) audits of various departments and site manufacturing & packing process to evaluate the level of systems compliance against selected QMS policies and to assess the operations to meet GSK requirements.
• Lead and manage Management Monitoring (L1) audits within the department as well as to ensure MM audits are managed within the organization in various relevant department.
• Conduct Vendors audit to assess QMS in the Identification, prioritisation and monitoring of Quality Compliance and any technical risk, which may affect the product quality.
• Ensure all the quality related CAPAs are managed by following the tracking system and closure in timely manner. Technical Terms of Supply
• Review and approve Technical Terms of Supply as per MOH / SFDA registration requirement.
• Supervise for reviewing the Bill of Material for new products. In-process Checks and Sampling Management
• Supervision of the QA random in-process checks at various stages of the site manufacturing and packaging as and when required.
• Supervise the sampling of all incoming raw materials and intermediate products are carried out as per the SOP / QMS requirements and in an efficient way.
Deviations / Change Controls / Validation / Calibration Protocols
• Involve in the review and approval of the calibration of devices to ensure that the Calibration, control, testing equipment used in product manufacturing is appropriately calibrated and maintained according to the system of GSK.
• Review and approve change controls for impact of changes and on validation status, investigation of GMP deviations and ensure that appropriate CAPA is taken.
Periodic Product Review
• Perform / carried out periodic product reviews and any non-conformance resultant actions are performed, and the non- conformances are resolved.
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Product Complaints and Investigations
• Manage product complaints to ensure all complaints on products are recorded, investigated and appropriate CAPAs are taken and communicated to complainant.
ACHIEVEMENTS
• Site QMS Implementation: Managed robust Quality Management System at GSK manufacturing site as per GSK group standard policy and local regulatory requirements and sustainability maintained during my service at site.
• Lean Sigma Project: Completed the GSAL site Lean Sigma Project for Zinacef 750mg x 5 vials Injection pack change, which brought substantial savings and made the process more efficient.
• Site Operational Excellence (OE) Project: Participated in “Excellence Recognition Awards Programme” of GMS under Operational Excellence project at GSAL site for the reduction in Quality Assurance sample size, which gave savings in retained samples cost.
• Lighten up exercise was performed at site as per Record Retention policy to discarded tons of obsolete documents which created massive retention space for documents samples etc.
In-Process Control Inspector Dec 1996 – Nov 2000
GSK Saudi Arabia Ltd.
• Inspect all areas of production pertaining to manufacturing, dispensing / issue of raw material and packaging.
• Strictly review and ensure all production batch manufacturing instructions and relevant Production SOPs are followed during the production and packing process.
• Perform routine sampling of raw material and intermediate products according to Glaxo Saudi Arabia Ltd Standard Operating Procedure.
• Prepare and issue In-Process checks reports. Present in-process checks anomalies in the Quality Review / Council meetings.
• Involve checking the critical devices of the instruments, etc.
• Involve in the review to develop of relevant Quality local SOPs as per GSK standard requirements. LANGUAGES English – Full Professional Working Proficiency
Urdu – Native Proficiency
Arabic – Limited Working Proficiency