• Responsible for Regulatory, Pharmacovigilance, Quality assurance, Quality control, Production, Packing, Warehouse, Engineering to implement and convert Quality Policy into routine practices & systems.• Responsible for overall co-ordination to build up and maintain Quality system in the Plant.• Responsible for the smooth operations of the plant and ensuring the compliance. • Responsible for the collecting, detecting and preventing adverse effects (AEs) in patients who take new drugs and other pharmaceutical products.• Ensuring that all safety-related activities are conducted in compliance with regulatory guidelines and internal company policies. • Reviewing and evaluating adverse event reports (AERs) to determine if they meet regulatory reporting requirements.• Entering and maintaining adverse event information in safety databases• Reviewing and assessing the safety profile of new and existing products.• Designing and conducting safety studies to evaluate the safety of a drug.• Ensuring that drugs are safe and effective for use by patients, minimising the risk of harm associated with their use.• Reviewing safety data for pharmaceutical products and assessing any potential risks associated with their use.• Reporting any adverse events associated with the use of a drug to regulatory agencies, ensuring that this information is documented and communicated to healthcare providers. • Responsibility & Authority to assuring quality of the products and systems through technical expertise and training. • Developing and implementing risk management plans to minimise the potential for harm associated with the use of a drug.• Responsible for overall co-ordination to build up and maintain Quality system in the Plant.• Responsible for the smooth operations of the plant and ensuring the compliance. • To co-ordinate during quality audits by various Customer & Regulatory Agencies and implement compliance to audit observations.