Sreerag Sreekumar

As a Corporate Quality Assurance Executive, I manage strategic, multi-plant quality oversight. My focus is on ensuring compliance, driving continuous improvement, and harmonizing quality standards across the organization.


Strategic Audit & Compliance Management: I lead the full audit lifecycle, conducting risk-based internal audits across all company plants. I actively perform 483 Gap Assessments and pre-audit evaluations to identify potential non-compliance areas and ensure readiness against regulatory observations. I also select audit teams based on SME expertise and ensure timely compliance closure.

Global Quality Implementation & Review: I oversee the global implementation of decisions regarding CAPA and Deviations to ensure consistency across all sites. I conduct comprehensive reviews of Quality Technical Agreements and analyze audit trends to resolve recurring issues.


KPI Management & Continuous Improvement: I manage Key Performance Indicators (KPIs) for Management Review Meetings (MRM) to track quality health and drive data-backed decision-making. I actively organize training sessions on audit procedures, update internal processes to match regulatory changes, and recommend initiatives for process efficiency.

At Alkem, I was responsible for hands-on, shop-floor quality assurance in a high-stakes regulatory environment.

Shop-Floor cGMP Enforcement: I ensured strict adherence to cGMP and GDP compliance. This involved conducting rigorous in-process inspections for tablets, capsules, strips, and bottles, as well as verifying line clearance at every critical stage of manufacturing and packaging.

Quality Systems Management: I gained deep, hands-on experience with core pharmaceutical quality systems. I was responsible for managing Deviations, CAPA, and Change Control directly through Trackwise. I also handled Caliber LIMS activities and was responsible for reviewing and creating electronic batch records (E-BPCR) in HITPHAMS software.

Investigation & Resolution: I served as a key member of the investigation team for market complaints. My role was to help identify the root cause and, critically, to implement and check the effectiveness of the resulting CAPA directly on the shop floor

At Exemed, I built my foundational QA skills, learning to maintain compliance standards while serving as a primary quality contact for major external partners.

Front-Line Audit & Customer Facing: I served as a key QA representative on the shop floor during numerous high-stakes inspections. I successfully faced audits from regulatory bodies like the EU and WHO, as well as major customers including Cipla, Lupin, Sun Pharma, and Dr. Reddy Labs.


Foundational cGMP Compliance: I was responsible for the daily enforcement of cGMP and GDP compliance. This included performing all in-process inspections for manufacturing and packaging, verifying line clearances, and meticulously reviewing Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and logbooks.


Quality Process Support: I assisted in the investigation of market complaints to determine root causes and was responsible for executing validation and qualification protocols.