Mustakeem Shaikh

About Mustakeem Shaikh

I’m a Chemical Engineer with over 2 years of experience in the Active Pharmaceutical Ingredient (API) manufacturing industry. My expertise lies in enhancing Quality Management Systems (QMS) to ensure GMP compliance and consistent product quality, while also supporting operations analytics and execution to drive business performance. I analyze quality and operational data to generate actionable insights, improve process efficiency, and support data-informed decision-making. I\'ve led root cause analyses (RCA), implemented CAPAs, and contributed to successful regulatory audits. My cross-functional work has spanned quality, production, and business teams, giving me a broader view of how compliance, efficiency, and growth intersect. I\'m also developing my skills in business development, operations analytics, and strategic execution, with the goal of bridging technical excellence with commercial impact. I\'m passionate about continuous improvement and exploring opportunities at the intersection of pharma operations and data-driven business strategy.

Experience

1. Engineer

   Fleming Laboratories

   Dec 2022 — Present · Hyderabad, IN

   Enhance Quality Management Systems (QMS) to ensure GMP compliance.• Analyse quality and process data to generate actionable insights and support continuous improvement.• Conduct root cause analysis (RCA) and implement Corrective and Preventive Actions (CAPAs).• Collaborate with cross-functional teams to improve manufacturing efficiency and maintain product quality.• Prepare documentation and assist in regulatory audits (e.g, USFDA, WHO-GMP) to ensure audit readiness and compliance.• Drive operational efficiency by identifying bottlenecks and suggesting data-driven process improvements.• Engage in continuous learning and development in areas such as operations analytics, quality metrics, and strategic execution.

Education

• Sinhgad College of Engineering

  Bachelor of Engineering - BE

  2017 — 2022