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8.0 - 12.0 years

0 Lacs

gujarat

On-site

As an IPQA Specialist in an API manufacturing environment, your primary responsibility will be to monitor production activities and ensure cGMP compliance on the shop floor. You will be required to review and approve Batch Manufacturing Records (BMR), Batch Cleaning Records (BCR), and related analytical records before releasing API. Preparation and revision of SOPs, BMRs, BCRs, and other QA-related documents will also be part of your duties, aligning them with regulatory and internal requirements. Sampling of APIs, maintaining related records, overseeing proper cleaning and maintenance of sampling tools, and managing storage of control samples of API will be crucial tasks to uphold quality s...

Posted 2 months ago

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11.0 - 14.0 years

11 - 14 Lacs

Hyderabad

Work from Office

Job Objective : 1. Excellent team player/leader can efficiently motivate the subordinates to achieve the set targets within stipulated time. 2. Proficiency in written and oral communication skills. 3. Ensuring best in class quality and timely project execution 4. Strong initiative in decision making and owing up of responsibilities. 5. Strongly believe in turnaround of Business, systems and procedures with an integration of internal skill set along with outstanding team building. Job Role: 1. All activities related to production and monitoring the process as per SOPs. 2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons. 3. Check and implement the...

Posted 3 months ago

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6 - 8 years

6 - 8 Lacs

Shamirpet, Hyderabad

Work from Office

Role & responsibilities Checking of SOP Compliance. Preparation and Updation of the Site Master File . Preparation and Updation of Validation Master Plan QA SOPs preparation/Revision. Execution of product Disposition/dispatch activity. Tracking of SOP revision due of all departments. Issuance, retrieval and destruction of SOP controlled copies. BMR, BCR issuance, retrieval and review. Line clearance after change over in production areas. Monitoring of routine manufacturing activities. Handling of Change Control. Handling of Deviations. Assist HOD QA for any technical information needed, documents requirement so as to carryout smooth and consistent day-to-day QA activities. Filling customer q...

Posted 5 months ago

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