6 Gmp Documents Jobs

In this role as a Quality Assurance professional, you will be responsible for the review and approval of Supplier Qualification documents, such as NSQR, VQ Documents, etc., from Raw material / Packing material manufacturers and external service providers. Your key responsibilities will include: - Preparing and distributing corporate approved supplier lists, New product tentative approved supplier lists, and Tentative approved supplier lists to all SQAs. - Providing support to site QA for regulatory audits and Customer audits. - Reviewing vendor notifications and coordinating with RA & SCM for further requirements. - Reviewing delist declarations from SCM and coordinating with RA & Site QA te...

As an experienced Maintenance Department professional, your role will involve: - Ensuring optimum machine availability, workforce, and shift schedules in the maintenance department, including the creation and execution of a Preventive Maintenance Plan (PPM). - Adhering to CGMP instructions, resolving technical issues, performing machine maintenance, and prioritizing safety and environmental considerations to minimize pollution and hazards, while also addressing breakdown maintenance promptly. - Taking charge of all engineering-related activities within the production plant, overseeing the preparation, verification, and review of GMP documents. - Managing the installation and commissioning of...

As a Sr. Manager - Micro Lead at Sun Pharmaceutical Industries Ltd in Ahmednagar, your role is crucial in overseeing the activities in Microbiology department. **Key Responsibilities:** - Planning, reviewing, and monitoring overall activities in Microbiology department - Coordinating with other departments to prioritize tasks and provide timely support/testing to avoid delays - Reviewing all departmental documents and results in LIMS system, ensuring completeness on time - Reviewing lysate sensitivity test, Bacterial endotoxin test of WFI and API products - Checking method validation of bacterial endotoxin test and microbial quality of products - Procuring, receiving, storing, maintaining, a...

As a Section Head - API Production in the Manufacturing department, your main responsibility will be to control manufacturing activities within your section. Your goal is to ensure that all activities are performed in compliance with cGMP and safety standards to achieve quality and manufacturing targets within the specified time frame. Your key accountabilities will include monitoring and controlling planned production on a daily basis to meet targets and quality standards, overseeing maintenance activities to optimize the use of manufacturing consumables, preparing and updating GMP documents to ensure regulatory compliance and product quality, managing manpower availability across shifts fo...

As a Micro Lead API at our Ahmednagar location in the grade of G9B- Sr. Manager 2, your primary responsibility will be to plan, review, and monitor all activities within the Microbiology department. You will lead the department, ensuring smooth coordination with other departments to prioritize tasks and provide timely support and testing to prevent delays in analysis. Your role will involve reviewing all departmental documents and results in the LIMS system specifically in the microbiology section. You will oversee the lysate sensitivity test, Bacterial endotoxin test of WFI and API products, as well as validate the bacterial endotoxin test and microbial quality of products. Additionally, yo...

Role & responsibilities The individual should be documenting Annual Product Quality Review (APQR): Collection of process and quality data for all products. The individual is capable for management of Retain Samples: Storage, maintain, visual inspection & destruction of Retain samples of all FG samples. Management of central document room/Documents: Issuance, Retrieval, Destruction & Control of all the GMP documents (eg: facility documents, Batch records, Protocols, Reports, etc.) Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The in...