22 Job openings found

1. Raw Material, Packing Material, Intermediate and Finished API analysis2. Analysis related Documentation3. Operation & Calibration of Polarimeter, FTIR, HPLC, GC4. Document preparation & management as per GLP & GDP5. Stability sample handling and analysis6. SOP preparation-revision, Analytical Method Validation and related documents preparation Should be proficient in wet chemical ...

Ensuring compliance to cGMP, GDP for plant operations Review and compare global quality policies, procedures and directives and regulatory guidelines with site procedures. Identify gaps and ensure updation of site procedures. Successfully managed Regulated and Semi-regulated market audits Drive team to productivity and reduce attrition rate; capable of sourcing candidates for own team in minimum timeline Tracking and investigations of OOS / OOT from manufacturing site on timely manner Checking compliance of response given to regulatory observation and queries Review and approve standard operating procedures, specification, master plans, standard testing procedure, protocols and reports Coordination with manufacturing, purchase, regulatory and R&D for smooth and timely execution of exhibit and commercial batches and new product launches. Review and completion of change controls of products, process, test method, equipment and facilities. Respond to inspection observation and business affiliate queries. Provide updates to regulatory agencies on compliance to response. Drive internal audit, ensure compliance to schedule and timely CAPA implementation.  Approve risk management protocols and reports pertaining to various quality systems Organize and lead team to execute timely batch processing through validation and checks Manage and respond to market complaints adequately Perform Risk analysis and management at regular intervals Have proven ...