- Lilly (Pleasant Prairie, WI)
- …make life better for people around the world. **Responsibilities:** The Associate Director , Validation is responsible for staffing, training, and leadership of ... to implement TS/MS validation objectives and deliver on business plan and quality objectives. + Network and collaborate with global and other parenteral sites to… more
- Fujifilm (Holly Springs, NC)
- …cleaning validation sections of CTDs and NDAs * Experience of Electronic Validation systems such as KNEAT or similar * Experience of Lives Temperature ... **Position Overview** The Associate Director , Cleaning Validation is responsible for...(Warehouse) areas * Leads the development of risk-based cleaning validation approaches incorporating Quality by Design (QbD)… more
- Gilead Sciences, Inc. (La Verne, CA)
- …standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Systems . **Basic Qualifications:** + Bachelor's degree in ... complex sterile product qualification activities. + Expertise in contamination control, cleaning validation and isolator systems . + Adopt best practices for… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are?...more than 280 employees. Your role Reporting to the Quality Director , JOB SUMMARY: This is a ... and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews and aids in developing… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams. +… more
- Stantec (Vestal, NY)
- …stored in GMP conditions and distributed, including computerized and automated systems which require qualification and validation for compliance. The ... commissioning and validation of equipment, facilities, utility systems and computerized systems are intended to verify that they are designed, installed,… more
- PCI Pharma Services (Rockford, IL)
- …Validation Engineer - Medical Device Assembly (CDMO)** **Location:** [Rockford] **Department:** Quality **Reports To:** Director of Quality **Position ... welding, and other medical device assembly technologies. + Familiarity with software validation and PLC-based control systems . + Six Sigma certification or… more
- Abeona (Cleveland, OH)
- … (eg, LIMS, ELN) . Clinical trial management systems (eg, CTMS, EDC) . Quality systems (eg, QMS, Document Management Systems ) . Manufacturing systems ... Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System … more
- Mount Sinai Health System (New York, NY)
- … and compliance with regulatory requirements. The CRM works in conjunction with the Associate Director and Director of DRG Validation to help develop coding ... methodology. ? Good working knowledge of electronic health records, registration and data systems . Non-Bargaining Unit, 618 - HSO Drg Validation - MSH, Mount… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- QA Director - Site Investigations & Quality systems Department: Quality Plant Head Location: Monroe, NC START YOUR APPLICATION ... with respect to investigation related observations. Serve as site representative for Quality Systems during regulatory inspections and corporate audits + To… more