Senior Officer, Analytical R&D Compliance

Amneal Pharmaceuticals

2 - 7 years

7 - 11 Lacs

Ahmedabad

Posted:15 hours ago| Platform:

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Skills Required

Manager Quality Assurance Compliance Analytical Standard operating procedures GLP Management Troubleshooting HPLC Monitoring Preventive maintenance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Below is the JD for GLP Position :

To perform / review daily calibration of laboratory equipment, lamp energy check, time synchronization check, temperature monitoring and any compliance related activities.
To maintain laboratory equipment in proper operating condition and perform calibration as required, after completion allied training of sophisticated instruments i.e. UPLC, HPLC, GC, ICP-OES, ICP-MS, Dissolution Apparatus etc.
To deliver consistent and precise results by following safety and GXP protocols/ SOPs/ regulatory guidance.
To associate service/instrument engineer during routine preventive maintenance and troubleshooting/repair services on all laboratory equipment.
To establish, execute and evaluate laboratory instrument calibration procedures and policies.
To prepare qualification protocol / report and compliance documents.
To prepare and execute the Computer Systems Validation protocols and to make sure that all GxP computer-based systems are operating as intended and meet regulatory requirements.
To interact with Quality Assurance and service providers, other cross functional department related to CSV, Qualification and PM activity.
To prepare / revise Standard Operating Procedures, through change control procedure in accordance to regulatory guidance / reference documents.
To update lab compliance documentation system to exceed good laboratory practice, nearly meeting site GXP quality standard expectations.
To create, update, review and manage of Calibration, Preventive maintenance, and validation schedule.
To review Third-Party Documents / Certificate of Analysis.
To receive and manage controlled issued documents from QA Department.
Issuance of Laboratory notebook, Equipment logbook and Column usage registers.
To qualify in-house Working / Reference standard and impurities.

Interested candidate can share cv on chandanid@amneal.com

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