Senior Executive- Filling Inj Manufacturing

5 - 9 years

0 Lacs

Posted:1 day ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Document Management Specialist, your role involves handling various responsibilities related to document management, production processes, and quality compliance. Your key responsibilities include: - Managing documents such as BMRs, BPRs, and master SOPs to ensure accuracy and completeness. - Preparing and reviewing master production documents to maintain quality standards. - Ensuring the proper functioning of the UAF in your designated area. - Handling change control, deviations, investigations, and CAPA processes efficiently. - Providing training to subordinates, technicians, and operators to enhance their skills and knowledge. - Conducting line clearance activities before starting production operations. - Checking and maintaining records and logbooks related to aseptic manufacturing processes. - Developing, reviewing, and implementing standard operating procedures for the sterile manufacturing department. - Overseeing cleaning and sanitization activities in General, Controlled, and Aseptic areas. - Promptly reporting any observations or issues with documents or machines to the department head. - Monitoring activities in General, Control, and Aseptic areas to ensure compliance with standards. - Verifying the qualification and calibration status of equipment and instruments to prevent delays. - Ensuring timely completion of scheduled activities in designated areas. - Participating in training sessions as per the schedule and adhering to the training needs identified. - Upholding cGMP, Good Document Practice, and discipline within the company premises. In addition to your responsibilities, your skills should include expertise in filling, stoppering, sealing, and decartoning, as well as proficiency in equipment operation, cleaning, dispensing, sterilization, mixing, washing, and batch documentation review. You should also have a basic understanding of cleaning, line clearance, people management, and team leadership. This role requires meticulous attention to detail, strong communication skills, and a commitment to upholding quality and compliance standards in document management and production processes.,

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