- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products ... Specifications. If completed by an external company, the computer systems validation (CSV) specialist will be responsible for obtaining these documents… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**... validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing,… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior Validation Specialist , assists with the validation activities ... validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation ) + Expert in cGMP documentation practices Physical… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... in Kansas City, MO (KCM) is hiring a Senior Validation Specialist I, BioAnalytics CSV & Compliance.... is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and Data Integrity… more
- Belcan (Indianapolis, IN)
- …* Assists in the development of cGMP operating procedures that relate to process, computer systems , and equipment validation . * Assures compliance with SOPs ... Quality Validation Specialist Job Number: 360132 Category:... ensures current Good Manufacturing Practices (cGMP) and FDA/Quality Systems are adhered to throughout the evaluation, review and… more
- Astellas Pharma (Sanford, NC)
- …activities including but not limited to equipment, instruments, utilities, clean rooms, computer systems , and manufacturing process. + Evaluate and approve ... ** Specialist , QA Validation (Onsite in Sanford,...oversight periodic review and lifecycle management activities for validated systems and computerized systems .Support revalidation as required… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key role in supporting ... test plans, and regulatory guidelines. + Proficiency in troubleshooting equipment and systems during validation activities. + Ability to manage multiple… more
- PACIV (Indianapolis, IN)
- …of all departmental computer systems . + Create, revise, and manage Computer Validation System (CSV) documentation to support validation execution and ... tailored to regulated environments. We are seeking a detail-oriented and proactive Validation Specialist for our Indianapolis, IN office to support compliance… more
- Bausch + Lomb (Tampa, FL)
- …elements: manufacturing/ packaging equipment, facilities, utilities, computerized systems , temperature-controlled areas/equipment, Media Fills, and sterilization ... and ethylene oxide; Media Fills, temperature-controlled area/equipment and Computerized systems . + Organizational, analytical, computer , writing and… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …+ Assists in the development of cGMP operating procedures that relate to process, computer systems , and equipment validation . + Assures compliance with SOPs ... NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and approval of … more
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