- PCI Pharma Services (Rockford, IL)
- …resolution of corrective action to complete the project. Primary contact for quality validation activities and managing expectations. Reviews and interprets ... configuration, and fundamentals of heating, air conditioning, and refrigeration systems. ** Computer Validation Focus:** _Associate's Degree in a related field… more
- Jabil (Hunt Valley, MD)
- …of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process ... and adherence to the established procedures and schedulesin alignment with corporate quality and operational goals. + Assess process validation capabilities… 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 ... Validation Specialist is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and Data Integrity Programs (DI),… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …much or all of the time. ORGANIZATIONAL RELATIONSHIP/SCOPE: Reports to the Manager Quality Validation . Must be self-directed to manage validation activities ... product quality and site compliance to regulatory requirements. The Lead Validation Engineer interfaces with Manufacturing, Quality Assurance, Quality … more
- Lilly (Lebanon, IN)
- …performance; commit to meeting targets. * Develop and implement the Process Control Validation Plan, Quality Documents, SOP's and Audit Readiness * Develop the ... metrics and visualization * Provide subject matter expertise for computer system validation and data integrity for...CFR Part 11, Data Integrity etc) and corporate Lilly quality policies and procedures * Maintain validation … more
- Biomat USA, Inc. (Research Triangle Park, NC)
- … Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance/control documentation. + Assists in the development of ... cGMP operating procedures that relate to process, computer systems, and equipment validation . + Assures...as needed. + Interacts with Donor Center and Field Quality /Operations personnel to facilitate validation testing to… more
- Novo Nordisk (Petersburg, VA)
- … areas (equipment, sterilization, cleaning, process clean & black utilities or computer validation ) preferred + Experience in cGMP documentation practices & ... validation activities + Create, review & approve validation procedures, specifications & quality documents for...regulations required + Basic computer skills including experience in the use of Microsoft… more
- Curia (Albuquerque, NM)
- …system validation activities, collaborating closely with production and quality teams. Key responsibilities include conducting computer system validations ... Validation Specialist II. Responsible for developing, reviewing, and executing validation protocols to support manufacturing and quality operations while… more
- Curia (Albuquerque, NM)
- …to ensure validation work is efficiently integrated into production and quality timelines. This role may also support investigations related to validation ... compliant with regulatory expectations. + Coordinate with cross-functional teams (eg, Quality , Manufacturing, Engineering) to ensure validation efforts align… more
- BioLife Plasma Services (Social Circle, GA)
- …regulatory requirements affecting that discipline or activity. + Experience writing/approving validation plans preferred. + Familiarity with quality assurance ... Every day, our BioLife Testing Laboratories' mission is to ensure the highest quality testing standards for the plasma we collect. The plasma our centers collect… more