Executive / Senior Executive, Analytical R&D OSD (GLP Compliance)
Amneal Pharmaceuticals
Description:
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To perform / review daily calibration of laboratory equipment, lamp energy check, time synchronization check, temperature monitoring and any compliance related activities.
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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.
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To deliver consistent and precise results by following safety and GXP protocols/ SOPs/ regulatory guidance.
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To associate service/instrument engineer during routine preventive maintenance and troubleshooting/repair services on all laboratory equipment.
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To establish, execute and evaluate laboratory instrument calibration procedures and policies.
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To prepare qualification protocol / report and compliance documents.
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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.
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To interact with Quality Assurance and service providers, other cross functional department related to CSV, Qualification and PM activity.
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To prepare / revise Standard Operating Procedures, through change control procedure in accordance to regulatory guidance / reference documents.
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To update lab compliance documentation system to exceed good laboratory practice, nearly meeting site GXP quality standard expectations.
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To create, update, review and manage of Calibration, Preventive maintenance, and validation schedule.
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To review Third-Party Documents / Certificate of Analysis.
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To receive and manage controlled issued documents from QA Department.
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Issuance of Laboratory notebook, Equipment logbook and Column usage registers.
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To qualify in-house Working / Reference standard and impurities.
Essential Functions:
- Calibration and Qualification of various instruments.
Additional Responsibilities: To assist for CSV activity with senior scientist
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
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