Job
Description
As a Sterile Manufacturing Supervisor at Amneal, you will be responsible for various key functions within the sterile manufacturing department. Your role will involve the following responsibilities: - Preparation, review, revision, control, and implementation of standard operating procedures for the sterile manufacturing department. - Preparation and review of protocols and reports as per requirements. - Management of documents such as BMRs, BPRs, and Master SOPs. - Handling of Change Control, Deviations, CAPA, and Investigations. - Generating general purchase indents for departmental items. - Preparation of production planning on a monthly and daily basis according to material availability. - Daily production reporting based on achieved production. - Ensuring validation and calibration of all equipment and lines. - Compliance with cGMP, GDP, and maintaining discipline in the department. - Providing training to subordinates, technicians, and operators. - Additional activities as per the requirement of HOD. - Attendance and facilitation of training sessions as per schedule and TNI. - Preparation and review of all master production documents. - Ensuring cleaning, sanitization, and operation of machines as per SOPs. - Control and operation of aseptic areas like sterilization, manufacturing, filling, and sealing. - Line clearance activities before commencing operations. Qualifications required for this role include: - Bachelor's Degree in B. Pharm (Required) - Master's Degree in M. Pharm (Preferred) - Master's Degree in M. Sc. (Preferred) You should have at least 10 years of experience in sterile manufacturing. Your skills should include proficiency in various operations such as depyrogenation, filling, stoppering, CIP & SIP, dispensing, sterilization, mixing, decartoning, washing, GMP compliance & documentation, filtration, accurate record-keeping, equipment calibration, issue resolution, cleaning, sanitization, and packing. Amneal is an equal opportunity employer that values diversity and inclusion, fostering a workplace free from discrimination based on caste, religion, gender, disability, or any other legally protected status. As a Sterile Manufacturing Supervisor at Amneal, you will be responsible for various key functions within the sterile manufacturing department. Your role will involve the following responsibilities: - Preparation, review, revision, control, and implementation of standard operating procedures for the sterile manufacturing department. - Preparation and review of protocols and reports as per requirements. - Management of documents such as BMRs, BPRs, and Master SOPs. - Handling of Change Control, Deviations, CAPA, and Investigations. - Generating general purchase indents for departmental items. - Preparation of production planning on a monthly and daily basis according to material availability. - Daily production reporting based on achieved production. - Ensuring validation and calibration of all equipment and lines. - Compliance with cGMP, GDP, and maintaining discipline in the department. - Providing training to subordinates, technicians, and operators. - Additional activities as per the requirement of HOD. - Attendance and facilitation of training sessions as per schedule and TNI. - Preparation and review of all master production documents. - Ensuring cleaning, sanitization, and operation of machines as per SOPs. - Control and operation of aseptic areas like sterilization, manufacturing, filling, and sealing. - Line clearance activities before commencing operations. Qualifications required for this role include: - Bachelor's Degree in B. Pharm (Required) - Master's Degree in M. Pharm (Preferred) - Master's Degree in M. Sc. (Preferred) You should have at least 10 years of experience in sterile manufacturing. Your skills should include proficiency in various operations such as depyrogenation, filling, stoppering, CIP & SIP, dispensing, sterilization, mixing, decartoning, washing, GMP compliance & documentation, filtration, accurate record-keeping, equipment calibration, issue resolution, cleaning, sanitization, and packing. Amneal is an equal opportunity employer that values diversity and inclusion, fostering a workplace free from discrimination based on caste, religion, gender, disability, or any other legally protected status.
