Assistant Manager-Manufacturing

You will be responsible for line clearance activities before commencing operations, following the preventive maintenance schedule of machines, cleaning and sanitizing the visual inspection and packing area, operating the machines, and filling the log of the general area according to SOP and work execution. Additionally, you must adhere to cGMP, GDP, and maintain discipline in the department, ensuring all employees follow the same standards. Your duties will also include ensuring that all equipment and lines are in a validated and calibrated status, preparing daily production reports, and creating production planning on a monthly and daily basis based on requirements and material availability. You will handle tasks such as change control, deviations, CAPA, investigations, as well as document management including BMRs, BPRs, and master SOPs. Moreover, you will be responsible for preparing and reviewing protocols and reports as needed, overseeing the preparation, review, revision, control, and implementation of standard operating procedures in the sterile manufacturing department. Line clearance activities before commencing operations like manufacturing, sterilization, and filling are also part of your responsibilities, as well as checking records and logbooks related to various manufacturing processes. In addition to your defined job responsibilities, you may be required to perform other activities as instructed by the Head of Department (HOD) and provide training to subordinates, technicians, and operators. You must attend training sessions as per the schedule and ensure training aligns with the Training Needs Identification (TNI) process. Key Skills required for this role include adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO), accurately completing BMRs/BPRs, understanding deviations, change control, and CAPA, as well as the ability to inspire and guide others towards common goals while fostering a positive team environment. Qualifications: M.Sc. / B. Pharm / M.Pharm.,