Omer Khawaja

Senior pharmaceutical & nutraceutical operations leader with over a decade of experience management, supply chain, manufacturing, regulatory affairs, nutraceutical consultation layout approvals ISO & GMP compliance and distribution. Successfully managed end-to-end logistics and customs compliance for international shipments, lead GMP/TQM-driven manufacturing and served as project manager of a nutraceutical consultancy advising on facility design and regulatory approvals. Currently directing nationwide and cross-border pharmaceutical distribution, negotiating supplier agreements and ensuring quality compliance across the network.

GMP ISO Compliance Manager Nutraceutical at Alfalah health care Pvt Ltd (2024-11 – Present)

• Audits & Inspections
• Conduct internal audits of manufacturing, warehousing, and QC areas
• Prepare for and host external/regulatory audits from DRAP notified bodies, customer audits
• Manage supplier/vendor qualification audits Maintain and improve QMS in line with GMP (DRAP GMP) and ISO standards (ISO 9001, ISO 13485, ISO 22000, etc.) Ensure documentation (SOPs, batch records, and work instructions)
• Manage supplier/vendor qualification audits
• Deliver GMP/ISO training to staff (new hires and refreshers)
• Build a "quality culture" across production, QC, QA, and warehouse teams

Project Manager — Distribution & storage at Briell pharmaceuticals Pvt Ltd (2022-02 – 2024-02)

• Led end-to-end distribution and logistics of pharmaceutical products to sole distributors nationwide and in neighboring countries
• Distribution project in neighbor country worth 15 million task done in 30 days
• Negotiated pricing and supply agreements with franchisers manufacturers, suppliers, and vendors to secure competitive terms
• Oversaw inventory management, including product delivery, loading/unloading, and stock inspections, to ensure safe and compliant transportation. Maintained regulatory compliance and quality standards across the distribution network
• Achieved distribution and sales target in time for company satisfaction and team

Project Manager Consultant (Nutraceuticals) at Goodman Health Pvt Ltd (2019-01 – 2021-12)

• Drafted clear and accurate regulatory correspondence in response to DRAP queries and inspection findings
• Researched product technical specifications and formulations in line with USP and BP standards
• Provided consultation on pharmaceutical construction and layout plans for full units and sections, including tablet, liquid, and powder, capsule and probiotic lines
• Prepared layout and site plans in accordance DRAP and environmental control bodies, soil reporting and industrial-area compliance requirements
• Secured layout plan design approvals from the drug regulatory authority prior to construction
• Acted as liaison between third parties for contract manufacturing and internal teams to design and develop new pharmaceutical products
• Drove business development activity, securing new contract & toll manufacturing

Production & Regulatory Management at Ace Biotics Pvt Ltd (2016-01 – 2018-12)

• Prepared and managed end-to-end submissions for new plant licensing and product registrations, ensuring compliance with DRAP requirements
• Trained staff in assembly and manufacturing processes for food supplements and nutraceutical products in line with relevant SOPs
• Managed operational standards and productivity targets in accordance with GMP and ISO requirements
• Achieving on-time shipment goals and production quality standards under Total Quality Management (TQM) approaches that increased output while maintaining quality
• Tracked submission timelines and followed up on approvals, maintaining accurate and up-to-date records of all regulatory activities
• Compiled, reviewed, and maintained regulatory documentation for new molecule Registrations, renewals, and variations

Senior Import Export Manager at Ace Biotics Pvt Ltd (2012-01 – 2015-12)

• Identified and cultivated a network of international suppliers and manufacturers for APIs, finished pharmaceutical products, excipients, and packaging materials
• Partnered with Regulatory Affairs and Quality departments to verify sourced products met DRAP and international regulatory standards
• Oversaw logistics, customs clearance and regulatory compliance for finished products to international standards, including SGS quality assurance, shipment tracking and coordination with customs brokers
• Prepared export/import documentation, including clearance documents, bills of lading and chamber documents
• Generated B2B leads and represented the company at pharmaceutical expo

Bachelor of Commerce in B.com – Punjab College Gujranwala (2008-01 – 2010-12)

ACCA in Accounting and Finance – CFE, Lahore, Pakistan (2010-01 – 2012-12)

Associate of Pre-Engineering High school in Mathematics, Physics, Chemistry, English – Govt College, Gujranwala, Pakistan (2002-01 – 2004-12)