Executive, Filling Amneal Pharmaceuticals

0.0 years

0 Lacs

hyderabad, telangana, india

On-site

Job Description To follow safety rules in the premises according to the company norms. To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP. Preparation and periodic revision of SOPs related to aseptic processing area. Monitoring of DP, RH and temperature in aseptic processing area. Responsible to perform the in process checks during filling. To ensure aseptic area cleaning and fogging to coordinating with engineering department as per the schedule. Operation and Cleaning of heating cooling skid, CIP & SIP skid. Responsible for environmental monitoring of (Viable) aseptic processing area. Timely completion of SOPs training and on the job trainings relat...

Posted 2 weeks ago

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Junior Officer, Filling & Sealing Amneal Pharmaceuticals

4.0 - 6.0 years

0 Lacs

hyderabad, telangana, india

On-site

Job Description To follow safety rules in the premises according to the company norms Monitoring of DP, RH and temperature in aseptic processing area To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP Responsible for operation and cleaning of area equipment present in the filling area like filling machine, Rubber stoppering, sealing machines, Isolators, Pass boxes, Glove cleaning and integrity testers including VHP. Responsible to carry out the filling, stoppering, lyophilization and sealing operations as per the SOP and BMR Responsible to perform the in process checks during filling. To perform aseptic area cleaning and fogging to coordinating with e...

Posted 3 weeks ago

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Executive, QA Validation Amneal Pharmaceuticals

2.0 - 6.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Validation Specialist, your role involves reviewing URS, DQ, and vendor/suppliers documents related to qualification. You will be responsible for preparing and reviewing Validation/Qualification protocols and reports. Your duties also include executing and reviewing Qualification/Re-Qualification and Validation activities of Equipment/System/Facility and Plant utilities. Coordinating with manufacturing, Engineering, and QC personnel for timely completion of Qualification/Validation/Re-qualification activities is a key aspect of your role. Additionally, you will be preparing and reviewing media fill and hold time protocols and reports. Your responsibilities extend to preparing Standard O...

Posted 3 weeks ago

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Senior Executive - QA Amneal Pharmaceuticals

5.0 - 9.0 years

0 Lacs

ahmedabad, gujarat

On-site

The role involves handling document issuance, distribution, and retrieval, including verification of various documents such as Batch Manufacturing records, Protocols, layouts, specifications, etc. Issuing approved Standard Formats and Logbooks to User Departments, as well as managing line-clearance checklists, interventions checklist, and BMR/BPR pages. Additionally, handling proposed changes per the change control procedure, assessing associated risks/impacts, and ensuring the implementation of action plans. Conducting investigations using root cause analysis tools, performing additional studies, and deriving appropriate CAPA. Managing recommended CAPA and evaluating the implementation of r...

Posted 3 months ago

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