| Validation Analyst North Carolina at North, Virginia, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=446467&uid= From: madhavi sharma, siriinfo [email protected] Reply to: [email protected] + years of experience in Instrument Validation in Pharmaceutical Excellent knowledge of Instrument Validation for Pharmaceutical devices Good Communication skills Available Onsite 5 days a week (not a remote job) Create and develop a Validation plan for various types of instruments used in pharmaceutical manufacturing, such as spectrophotometers, chromatography systems, dissolution testers, and particle size analyzers. Perform Instrument qualification such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities to demonstrate that instruments are properly installed, calibrated, and capable of producing accurate results within predefined specifications. Perform Calibration to ensure that instruments maintain accuracy and precision, in accordance with regulatory requirements and internal standards. Collaborating with scientists and analytical chemists to validate analytical methods used for testing pharmaceutical products, ensuring that the instruments used in these methods are validated and suitable for the intended purposes. Compliance with regulatory guidelines and adhere to relevant regulations and guidelines, such as those from regulatory bodies like the FDA (Food and Drug Administration) and ICH (International Council for Harmonisation), and ensuring that instrument validation activities meet the necessary regulatory requirements. Perform Data analysis by collecting, analyzing, and interpreting validation data, performing statistical analysis when required, and documenting all validation activities and results in compliance with Good Documentation Practices (GDP). Follow the Change control process and manage any deviations or non-conformities identified during instrument validation activities, including investigation, root cause analysis, and implementation of corrective actions. Collaboration with cross-functional teams, including quality assurance, manufacturing, and research and development, to understand their validation needs, provide technical support, and communicate validation status and results effectively. Participating in internal and external audits or regulatory inspections related to instrument validation, providing necessary documentation, and addressing any findings or observations. Requirement Management Excellent knowledge of Instrument Validation for Pharmaceutical devices Good Communication skills Keywords: http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=446467&uid= |
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| 11:47 PM 25-Jul-23 |