Syed Danish Email & Phone Number

Jeddah, Makkah, Saudi Arabia

• Strategically lead company projects (New Site, Contract Manufacturing (CMO), Site Acquisitions, etc.) from Quality perspective.• Spearhead the Validation team to ensure that the site and its manufacturing processes are in a validated state.• Efficiently manage the change control system, thoroughly assessing and implementing all site changes.• Ensure regulatory compliance in 30+ export markets.• Review and negotiate Quality Agreements with third-party vendors to ensure adherence to quality standards.• Lead MSEP (mono source exit program) and vendor qualification/ supplier qualification initiatives.• Manage material and product Non-Conformances, initiate investigations, implement CAPA, and monitor effectiveness.

Jeddah, Makkah, Saudi Arabia

• Successfully led and managed 3 international projects (CMO, New Sites).• Established Quality Agreements with suppliers and CMO ensuring adherence to quality standards.• Spearheaded 5 RSO/Continuous improvement projects, driving significant SKU reductions of over 30%.• Ensured regulatory compliance for a portfolio of 1000+ SKUs in both local and export markets and implementing necessary measures to maintain market authorization.• Efficiently managed the Site Change Control system, overseeing the approval and implementation of variations to ensure compliance.

Jeddah, Saudi Arabia

• Effectively managed and provided leadership to a team of 7 in-process control inspectors, ensuring GMP/ compliance of site including aseptic manufacturing area.• Successfully enhanced the site's deviation handling and Corrective and Preventive Action (CAPA) management system to address issues effectively and minimize the likelihood of problem recurrence.• Conducted risk assessments to identify potential quality issues and implemented appropriate measures to mitigate risks, ensuring the delivery of high-quality products.

Jeddah, Saudi Arabia

• Performed Product Quality Reviews (PQR/ APQR) to assess and evaluate the overall quality of products and prospects of continuous improvement.• Handled Out of Specification (OOS) for raw materials, packaging materials, and finished products.

Karāchi, Sindh, Pakistan

• Led SAP implementation as Power User (Quality Management) resulting in successful implementation of SAP QM Module.• Accountable for managing all Quality Assurance functions, ensuring adherence to quality and regulatory requirements.• Successfully managed Change Request system, Market complaint, deviations, Audit programs and Product Quality Review processes to maintain compliance and drive continuous improvement.• Conducted review of batch documents/ batch records and executed batch releases, ensuring product quality compliance.

Karāchi, Sindh, Pakistan

• Conducted testing of raw materials, finished products, and stability samples utilizing advanced analytical instruments such as High-Performance Liquid Chromatography (HPLC), Atomic Absorption Spectrophotometer (AAS), Fourier Transform Infrared Spectroscopy (FTIR), Gas Chromatography (GC), and other cutting-edge technologies.• Performed Analytical Method Validation to validate the robustness and ruggedness of analytical methods.• Established specifications and test methods for raw materials and finished goods.• Executed equipment calibration activities to ensure accurate and reliable measurements.

Karāchi, Sindh, Pakistan

• Ensured quality compliance in both sterile and non-sterile areas across 10+ production lines.• Conducted area monitoring activities in sterile areas to ensure a controlled environment.• Collaborated closely with production staff to establish and meet quality standards.• Sampled products at various stages of production to perform inspections and tests.• Conducted testing and analysis of raw materials and finished goods.

Karāchi, Sindh, Pakistan

Testing of Raw Materials and Finished Products

Master'S Degree, Applied Chemistry

Bachelor'S Degree, Applied Chemistry