QA

Familiarity with high-performance organizational tools and a strong understanding of digital manufacturing processes, computer system validation requirements, and quality management within biologics production and quality.

Master’s Degree in Chemistry or Pharmaceutical Chemistry or Pharmaceutical Analysis, Quality Assurance from a recognized University or equivalent. Working expertise in HPTLC, HPLC, ICP- OES and Plant based Drug Standardization, Analysis of Aflatoxin & Pesticide residue. Skills of drafting and editing of scientific documents, technical reports

Handling and Execution and investigation of QMS documents in change controls, deviations, and CAPA. Review of Analytical Method Validations, Method Transfers, Protocols & Reports. Experience in review of HPLC, GC, LCMS calibration data & Analytical Data review. 

Responsible to handle the team to achieve the set targets & maintain qualitative, quantitative as well as cGMP aspects.

After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times.

Collecting and submitting in-process samples, finished product samples, stability samples, control samples, cleaning samples, and other samples as per the respective procedures, batch manufacturing records and packing records, protocols. Conducting AQL inspections and periodic inspections of control samples

Responsible for implementation of quality systems within the site. Review of Change controls, Deviations, Investigations, CAPA, OOS and OOT reports. Responsible for review of validation protocols and reports.

Review of environment monitoring records. Sterility testing of the finished products and sterile API. Should have good knowledge in QMS activities.