QMS Specialist - Pharmaceuticals Manufacturing

We are seeking a highly motivated and detail-oriented Quality Management System (QMS) professional to join our Quality Assurance team at Mendine Pharmaceuticals Pvt Ltd. As a part of our team, you will play a crucial role in ensuring compliance with regulatory requirements and company standards by implementing and maintaining effective quality management systems. Your responsibilities will include managing various quality-related activities such as quality risk management, batch manufacturing record preparation, process validation, deviation management, and more. In your role, you will be expected to identify, assess, and mitigate quality risks associated with products and processes. You will also be responsible for implementing and maintaining a quality risk management system in alignment with regulatory guidelines. Additionally, you will prepare and review Batch Manufacturing Records (BMRs) to ensure accuracy and compliance with regulatory requirements, as well as coordinate and execute process validation activities while ensuring compliance with regulatory standards. Furthermore, you will develop and maintain packaging material specifications, prepare and review Annual Product Quality Reviews (APQRs), coordinate cleaning validation activities, manage deviations from established processes and procedures, oversee change control activities, prepare batch cards, and coordinate technology transfer activities. Collaboration with Regulatory Affairs (RA) and Research & Development (R&D) teams on quality-related matters will be essential to ensure effective communication and coordination on quality-related activities. To be successful in this role, you should possess a Master's degree in Pharmacy along with a minimum of 3-7 years of experience in a QA/QMS role within the pharmaceutical industry. Strong knowledge of regulatory requirements such as cGMP, ICH, and ISO 9001 is necessary, along with excellent analytical, problem-solving, and communication skills. The ability to work independently and lead cross-functional teams will also be vital for this position. As part of our team, you will receive a competitive salary based on your present package and industry norms, along with opportunities for professional growth and development in a collaborative and dynamic work environment. If you are an eligible, motivated, and detail-oriented professional with a passion for quality management, we invite you to submit your application for consideration.,