Aaditya Tyagi

Experienced Pharmaceutical Quality Control professional with 11+ years of expertise in QMS, AMV, Stability Studies, Investigations, and Regulatory Compliance, seeking a challenging position to drive quality excellence, strengthen compliance systems, and contribute to organizational success.

Assistant Manager – QMS & AMV - Biodeal Pharmaceuticals Pvt. Ltd.

(2025-07)

• Managing Quality Management System (QMS) activities within the Quality Control Laboratory.
• Review and approval of SOPs, STPs, GTPs, Specifications, Protocols, Reports, and Quality System documents.
• Leading investigations related to OOS, OOT, Deviations, Laboratory Incidents, and Market Complaints, including root cause analysis and CAPA effectiveness review.
• Performing trend analysis of laboratory investigations and identifying opportunities for continuous improvement.
• Handling Change Control, Risk Assessment, CAPA, and effectiveness verification activities.
• Coordinating and supporting internal audits, self-inspections, and regulatory audit preparedness activities.
• Participating in customer, regulatory, and corporate audits and ensuring timely closure of audit observations.
• Conducting gap assessments against GMP, GLP, Data Integrity, 21 CFR Part 11, and EU Annex 11 requirements.
• Reviewing audit trails, electronic records, and analytical data to ensure Data Integrity compliance.
• Monitoring QMS metrics and preparing monthly quality review reports for management.
• Supporting Analytical Method Validation (AMV), Method Transfer, and Stability Study programs.
• Providing training to QC personnel on QMS procedures, investigation practices, GMP, GLP, and Data Integrity requirements.
• Driving continuous improvement initiatives to strengthen laboratory compliance and inspection readiness.

Senior Executive – Quality Control - Akums Drugs & Pharmaceuticals Ltd.

(2023-07 - 2025-06)

• Reviewing analytical data generated through HPLC, UPLC, GC, UV, and Dissolution systems.
• Managing stability studies and ensuring timely completion of testing activities.
• Reviewing laboratory documentation and ensuring GMP compliance.
• Investigating laboratory deviations, OOS, and OOT results.
• Supporting regulatory and customer audits.
• Training laboratory personnel on GMP, GLP, and Data Integrity practices.

Executive – Quality Control - Abryl Laboratories, Derabassi - Derabassi

(2022-09 - 2023-06)

• Performing analysis of finished products, raw materials, and stability samples.
• Operating HPLC, Dissolution Apparatus, UV Spectrophotometer, and FTIR.
• Preparing analytical reports and maintaining laboratory records.
• Ensuring compliance with approved procedures and specifications.
• Participating in investigation and troubleshooting activities.

Executive – Quality Control - Jubilant Generics Ltd., Roorkee - Roorkee

(2018-02 - 2022-08)

• Conducting analysis of tablets, capsules, oral liquids, and stability samples.
• Performing method execution and routine quality control testing.
• Reviewing analytical results and laboratory documentation.
• Supporting validation and qualification activities.
• Ensuring compliance with GMP, GLP, and Data Integrity requirements.
• Assisting during regulatory inspections and internal audits.

Assistant Executive – Quality Control - Akums Drugs & Pharmaceuticals Ltd.

(2017-04 - 2018-02)

• Analysis of finished products and raw materials.
• Routine operation and maintenance of HPLC, UV, and Dissolution instruments.
• Documentation of analytical activities as per GMP requirements.
• Preparation of laboratory records and test reports.

Officer – Quality Control - Wockhardt Life Sciences Ltd., Baddi - Baddi

(2015-07 - 2017-03)

• Analysis of raw materials, in-process samples, and finished products.
• Execution of wet chemistry and instrumental analysis.
• Calibration and routine verification of laboratory instruments.
• Preparation and maintenance of analytical records.
• Compliance with GMP, GLP, and laboratory safety requirements.

Bachelor of Pharmacy - SD Management