Urgent Opening for General Manager-Quality

Job Description:

• 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 multi department and multi-tasking operation