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.

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).
• 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