1 Opening(s)
14.0 Year(s) To 25.0 Year(s)
10.00 LPA TO 18.00 LPA
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 ...