Pharma QA Validation Specialist

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesnt just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

• Initiate and execute Validation/Qualification projects throughout the facility.
• Interact with all levels of management and staff to manage and facilitate the Validation/Qualification process.
• Plan schedule and organize Validation/Qualification projects for new and existing areas including manufacturing processes utilities facility cleaning equipment computer system and hold time study.
• Manage Site Qualification Master Plan including all related Validation/Qualification Master Plans
• Identify necessary internal and external resources for completion of Validation or Qualification projects and secure the necessary support (Production QC QA outside contractors).
• Interface extensively with the QC Production PDL and Maintenance departments to identify projects and problems requiring validation support.
• Collaborate with maintenance to ensure that all supplier qualification documents are reviewed and approved.
• Collaborate internally and with other related departments to execute Validation/Qualification in accordance to established approved protocols.
• Write validation final reports that present summarize data and formulate conclusions on the validity of the process based on the results of the analysis.
• Collaborate with the process owner to ensure that the output of the Validation/Qualification is implemented into the appropriate procedure.
• Lead root cause investigations process and apply corrective actions when required related to finding from validation projects.

We are an Equal Opportunity Employer. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates collaboration.

Required Experience:

IC