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Senior Executive, Validation Engineering, Technical Writing
Actively Reviewing
Amneal Pharmaceuticals
Job Description
Job Description
To prepare validation documents such as Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and other Qualification documents for equipment /utilities/facilities and generate reports which summarize results, specification and its acceptance criteria.
To track for SOPs due for review, circulating for comments, updating of comments, initiate change control, initiate ERA workflow and follow-up for execution, approval and closure.
To prepare Monthly Calibration Schedule and Preventive Maintenance Schedule as per US FO requirements.
To upload/review calibration reports in BMRAM and other BMRAM related activities.
To work in Caliber QAMS, Epiq DMS and Vaisala Viewlinc system.
To arrange Quotes for new equipment as and when requires.
Additional Responsibilities
QUALIFICATIONS
Education
To prepare validation documents such as Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and other Qualification documents for equipment /utilities/facilities and generate reports which summarize results, specification and its acceptance criteria.
To track for SOPs due for review, circulating for comments, updating of comments, initiate change control, initiate ERA workflow and follow-up for execution, approval and closure.
To prepare Monthly Calibration Schedule and Preventive Maintenance Schedule as per US FO requirements.
To upload/review calibration reports in BMRAM and other BMRAM related activities.
To work in Caliber QAMS, Epiq DMS and Vaisala Viewlinc system.
To arrange Quotes for new equipment as and when requires.
Additional Responsibilities
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years
Required Skills
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