KHURRAM AHMED

• Responsible for the Manufacturing and Supply of Quality Products.
• Leading BF Biosciences site with key understanding of the site top priorities and business objectives and accomplishing the goals.
• Liaison between the Manufacturing and Commercial function to cater the demands by robust supply plan.
• Ensure both short and long-term capacity plans in-place and being timely adhered to ensure a robust Supply Chain.
• Engaging and leading the dynamic manufacturing Site Leadership Team for a lean approach of Continuous Improvement and Production Systems.
• Providing leadership and Direction to team for the accomplish Site Top priorities.
• Ensuring that all required Quality, safety and regulatory compliance are in place in use.
• Sponsoring the culture of Empowerment, Continuous Improvement, Engagement and Tiered Accountability and develop high performance team in the organization.
• Timely delivery of Projects and new product launch.
• Provide technical guidance and support to team in day to day activities.
• Setting Site KPIs with effective Monitoring and recalibration against the Target.
• To monitor and review performance of metrics against the targets and liaise periodically with CEO and Commercial heads to agree improvement areas.
• Leading the MHRA, WHO and PICS pre-assessment for Site.
• Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
• Cultivated a positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
• Improved project efficiency with strategic planning, resource allocation, and time management practices.
• Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
• Implemented innovative solutions to solve complex problems, resulting in increased productivity and streamlined operations.
• Facilitated cross-functional collaboration for improved decision-making processes within the organization.
• Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects or business operations.
• Evaluated employee performance objectively using established metrics, leading to fair compensation adjustments based on meritocracy principles.
• Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.

New product development and Registration:

• Successfully developed and launched local manufacture insulin into the market .
• Successful developed and launched pakistan first synthetic peptide Semaglutide with scientific studies on Bioassay Kit ,Pharmacokinetic ,Toxicology and structure elucidation.
• Successful development and initiation of 38 new molecules for newly installed line 02 BF biosciences .
• Successfully development of Terzipatide and its relevant studies for CTD dossier.
• Source optimization and alternate development for biopharmaceuticals .
• Successfully registration of Contrast media like Iohexol .
• Development of luerlock for Semaglutide to make it more patient complaint .

New Projects :

• Successfully commenced and started new Prefilled syring section .
• Successfully started State of art line 02 for the non biopharmceutical products .
• Layout ,designing and new injectable facility completion as per latest guidelines.
• Successful pre assessment of site by MHRA auditors for future exports.
• Technology transfer from gliead to pakistan BF biosciences for first HIV product lenacapavir injectable.
• Site readiness for FDA audit for the export of lenacapavir .

• Leading the Citi pharma API and Formulation operations as a chief operating officer with key understanding of the site top priorities and business objectives and accomplishing the goals.
• Ensuring the business operations is managed and governed to deliver Strategy Deployment targets for the Site, which links to the Manufacturing Strategy.
• Ensuring the Safe, Healthy and Productive Environment In the facility in order to meet business objectives by maintaining the quality of products.
• Ensure both short and long-term capacity plans in-place and being timely adhered to ensure a robust Supply Chain.
• Ensuring that all required Quality, safety and regulatory compliance are in place in use.
• Sponsoring the culture of Empowerment, Continuous Improvement, Engagement and Tiered Accountability and develop high performance team in the organization.
• Oversaw day-to-day operations across multiple departments, ensuring timely delivery of projects and streamlined workflows.
• Oversaw day-to-day operations to keep organization running smoothly while meeting business goals.
• Streamlined operations by implementing efficient processes and systems, leading to increased productivity and cost savings.
• Formulated strategic plans aligning with overall company vision; setting achievable short and long-term goals to drive growth and profitability.
• Ensured regulatory compliance by developing policies in line with industry best practices to mitigate risks associated with legal or ethical violations.
• Mentored team members by sharing knowledge, offering guidance, and providing constructive feedback; fostering a culture of continuous learning and development within the organization.
• Guided teams through periods of significant change by providing clear communication and decisive leadership during transitions.

• Leading the Largest Pharmaceutical Plant in the GSK regional Network as Head Of Quality/Director Quality.
• Have also led the site as an Acting site director on numerous occasions successfully with key understanding of the site top priorities and business objectives and accomplishing the goals.
• Ensuring the Site is managed and governed to deliver Strategy Deployment targets for the Site, which links to GSK’s Manufacturing Strategy.
• Engaging and leading the dynamic Quality leadership as well as Site Leadership Team for a lean approach of Continuous Improvement and GSK Production Systems.
• Ensuring the Safe, Healthy and Productive Environment In the facility in order to meet GSKs ambition of Zero Accident, Zero Waste and Zero Defects.
• Delivery against Safety, Quality, Service and Financial Targets for the Site to serve the market in the most optimal manner.
• Ensure both short and long-term capacity plans in-place and being timely adhered to ensure a robust Supply Chain through CCC process.
• Ensuring Regulatory Compliance and Alignment with the Government of Pakistan as well as GSK Policies.
• Sponsoring the culture of Empowerment, Continuous Improvement, Engagement and Tiered Accountability.
• Fostering Root Cause Analysis Approach for the Patient focused and safe production environment at factory floor.
• Facilitating a transformation plan at Quality and at Site, aligned with Global Manufacturing Strategy of GSK to make the supply chain more integrated and robust with Quality at the heart of everything.
• Also supported the site in preparing the Preparing Annual Budgeting & CAPEX Plan for the compliance of FMP. Ensure timely execution of budgeted resources to avoid variances & meet financial targets.

• Lead and ensure consistent implementation of sustainable GSK Quality Management Systems and GSK Standards / requirements for Pakistan.
• Lead and implement strategies and influence Country Commercial Leadership teams to continuously improve the performance of the Quality standards and requirements in their areas of responsibilities.
• As a member of Commercial Country Leadership Team leading quality management review for Commercial process performance and product quality in supply chain.
• Ensure implementation of GSK Quality Management System and /GDP requirements at country and upcountry level.
• To monitor and review performance of metrics against the targets and liaise periodically with General Managers and Commercial heads to agree improvement areas.
• Determine the responsibilities of LOC Quality Staff to ensure effective, overall quality management and continuous improvement of supply chain activities in LOCs.
• Create and identify opportunities to share information, documentation and knowledge between LOCs and driving simplification and improvements.
• Ensure timely and effective escalation of quality incidents and provide the necessary analysis to understand and escalate issues which have the potential to impact supply or GSK’s reputation as a manufacturer of quality products.
• Responsible and manage incidents via the PIRC process and take on the role of LIC Chair for incidents relating to LOC Quality in Area. Act as a coach/provide advice to the PIRC and other PIRC chairs.
• Actively manage the country quality team and set up their development and objective targets and develop a plan of support visits to LOCs based on people management needs and risk.
• Act as a quality contact for Supply chain and commercial teams as relevant in relation to quality and compliance issues.
• Coordinate LOC and Distribution Center site readiness for Health Authority inspections and proactively manage interactions and commitments to Health authorities.
• Ensure effective Quality Management of New Product Introduction, the distribution network in Area, complaint management, artwork management and Product release is conducted in line with local regulatory requirements.
• As a partner with Supply Chain including the Regional LOC Quality Lead and especially the LOC General Managers to ensure that their business requirements are understood and are in complied with latest Quality Management requirements and policies.
• As a Quality lead in LOC responsible to advice on how to manage Incidents/Complaints/potential recall situations for countries in their area, lead internal recall discussions and ensure the outcome is executed according to country regulations.
• Lead and advice on how to communicate with regulators within their geographic area and for key/priority markets will speak directly to regulators to negotiate preferred outcomes.
• Provide oversight and lead the Trainings of warehouse and commercial team on updated polices and Sops.
• Responsible to conduct Commercial Quality Council to update Commercial Leadership team about quality improvements, KPIs, Quality plan, Deviation, Customer complaint, LIC/PIRC, CAPAs, Risks and TTS.
• Responsible and leads effective Quality Critical Parameters are in place in use and are aligned with latest QUMS release.
• Lead the process of batch release and TTS (Technical Term of Supply) handling.
• Update Regional Team about the LOC performance on monthly basis in Regional Quality council.
• Lead and oversight Distributor Quality management by reviewing and approving Quality agreements and Conduct Quality Assessments of the Distributors.
• As a GSK Certified Auditor Responsible to Conduct Quality Audits of LOCs functions and Distributors.
• Managing the release of imported products into the market.
• Leading the management and handling of cold chain products of GSK in Pakistan.
• Reviewing and approving Technical term of supply for imported products.
• Responsible for the review and approval of Quality agreements with third parties.
• Leading the Quality area in Warehouse network optimization project.
• Leading the quality requirements for the reinstate of the GSK business at Iran.

• Involve in the manufacturing filling sterilization operations of sterile area.
• Broth fills operation of sterile area.
• Deep knowledge about sterile process validation.
• Involve in the validation & re-qualification of sterilizers.
• Involved and lead the validation of sterile area, Air flow studies and air balancing activities.
• Involved in the implementation of Current GQPs & GQMPs requirements for sterile area.
• Manage and lead Audits of sterile areas.
• Lead the Process of validation, installation of filling machines and their qualification in sterile areas.
• Developed method procedures for the sterile operations.
• Manage and lead Alignment of LSOP with CGMP requirements of sterile areas and training of staff on required procedure.
• Managed sterile operation and packaging operations.
• Involved in tablet manufacturing, compression, lozenges compression, film coating, sugar coating of tablets.
• Involve in different activities related to validation i.e. documentation, effective implementation of change, Design qualification, Installation Qualification and Performance Qualification and Cleaning Validation and Verification activities.
• To ensure compliance with GMP and working as a Quality Management System expert and ensuring implementation of Quality Management System within department by applying Global Quality Policies (GQPs), Global Quality Guidelines (GQGs) and Global Quality Management Procedures (GQMPs).
• Involved in manufacturing of ointment, drops, and aerosol manufacturing packaging and warehousing.
• Conducted different level of audits (Self inspection and monitoring audits along with the ministry and MIA audits).
• Involved in the Level 2 audits as an effective audit team member at site along with the departmental self inspections and compliance of regulatory and MIA (Manufacturing Internal Audit) audits CAPAs on timely basis.
• Member of risk management panel and involve in Risk Management of the site.
• Involve in the management of documentation of audits, implementation of SOPs, GMP and EHS in all areas.
• Participating and liaising with other departments in investigation and providing expertise in various areas of production.
• Involve in the checking of Periodic Product reviews and ensure that all the process are as per define standard and also for the identification of areas of improvement.
• Contribute and participate with OEE team in achieving site OEE targets and in implementing Vision Factory Future State Model.
• Conduct different training related Aseptic processing and manufacturing.
• Production planning & management to meet the monthly site production targets.
• Involved in the introduction of new product as well as product and technology transfer from one site to other site with effective implementation of process.
• Involved in the new sterile facility design as an effective team member.
• Evaluated new technologies and equipment upgrades to determine potential benefits for the company''s production capabilities.
• Led cost-saving initiatives by identifying areas of waste reduction and process improvements, contributing to increased profitability.
• Increased overall product quality by enhancing quality control measures and training staff in best practices.
• Analyzed production data to identify inefficiencies, recommending changes that led to improved output rates.
• Reduced downtime for equipment maintenance through effective scheduling and resource allocation.

• Worked as production lead for Disprin Value Stream.

• Involve in dispensing of drug information, purchasing, coding of drug in system involve in pharmacy setup for in and out patient, introduced unit dose system for in patient, Patient counseling & education about drug interaction.

• Worked as Production officer in Abbott laboratories in Tablet, liquid and Semisolid value streams.

• Involve in dispensing, dose adjustment, drug information.
• Purchase requisition and purchase order generation, also worked in cancer pharmacy of same hospital involve in drug dilution and information.