Senior Executive- Filling Inj Manufacturing

3 - 7 years

0 Lacs

Posted:2 weeks ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Document Management Specialist in the sterile manufacturing department, you will be responsible for various crucial tasks. Your primary duties will include managing documents such as BMRs, BPRs, and master SOPs. You will be in charge of preparing and reviewing master production documents and ensuring the Unit Area File (UAF) is functioning correctly in the designated area. Additionally, you will handle change control processes, deviations, investigations, and CAPA activities. Providing training to subordinates, technicians, and operators within the department will also be a key aspect of your role. It is essential to perform any activities assigned by the Head of Department (HOD) beyond the defined job responsibilities, following the HOD's instructions and guidance. Ensuring line clearance before commencing operations and checking records and logbooks related to aseptic manufacturing equipment are vital tasks within your scope of responsibilities. You will be accountable for the preparation, review, revision, control, and implementation of standard operating procedures in the sterile manufacturing department. Maintaining cleanliness and sanitization in the General, Controlled, and Aseptic areas is crucial. Promptly reporting any issues related to documents or machines to the department head is required. Monitoring activities in the General, Control, and Aseptic areas, as well as ensuring equipment qualification and calibration status, are also part of your responsibilities. Attending scheduled training sessions, following the cGMP guidelines, practicing Good Document Practices, and maintaining discipline within the company premises are essential aspects of this role. Qualifications: - M.Pharm./ B.Pharm./ M.Sc. Experience: - 3-7 years of experience in manufacturing Injectable Products.,

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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