Officer, Quality Assurance Amneal Pharmaceuticals

0.0 years

0 Lacs

hyderabad, telangana, india

On-site

Job Description Responsible for routine monitoring of Manufacturing Areas. Responsible for the routine GMP Inspection & review of Quality Records of other departments. To monitor and ensure compliance level of organization is as per current GMP requirement Good Documentation recording and updation. Responsible for review of URS, DQ and vendor / suppliers documents related to qualification. Responsible for preparation of Validation / Qualification protocol and report. Responsible for execution and review of qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant Utilities. Responsible for adequacy of execution of validations being carried out at pre...

Posted 2 days ago

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Manager Sterile Micro EM Compliance Immacule Life Sciences

10.0 - 15.0 years

15 - 18 Lacs

nalagarh

Work from Office

Role & responsibilities - Ensure and assist the Head Sterile Quality Compliance for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at the microbiology laboratory. - Participate in the sterile quality management review periodically - Ensure the microbial monitoring program in the site is adequate Environmental Monitoring (EM) Personnel Monitoring Media Fill Simulations (Process Simulations) - Periodic review and routine check of classified areas in microbiology lab areas - Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product - Participate in the...

Posted 3 weeks ago

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Executive - Quality Control Micro Amneal Pharmaceuticals

2.0 - 6.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a responsible team member in the pharmaceutical manufacturing process, your role involves the following key responsibilities: - Conduct line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. - Perform process validation, cleaning validation/verification, hold time study, media fill, and routine batch sampling according to protocol/SOP. - Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs). - Perform in-process tests at different stages as per batch documents/SOP. - Review environmental monitoring and water trends. - Review different types of calibration certifica...

Posted 1 month ago

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Senior Officer, QA Environment Monitoring Amneal Pharmaceuticals

2.0 - 6.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be responsible for conducting line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. Additionally, you will perform environment monitoring activities and ensure compliance with cGMP at the shop floor. Your role will involve process validation, cleaning validation/verification, hold time study, media fill, routine batch sampling, and in-process testing at different stages according to batch documents and SOPs. You will review executed BMRs, BPRs, environment monitoring data, water trends, printouts (CIP, SIP, autoclave, filter integrity), and different types of planner and calibration certif...

Posted 2 months ago

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