- DivIHN Integration Inc (Medina, NY)
- …employment prerequisites and job responsibilities for the position of Principal Engineer, Quality Validation . II. ESSENTIAL FUNCTIONS: The person in this role ... Prefer experience with TQM methods (eg six sigma). Internal Quality System auditing experience (ISO 13485 and FDA.../ DAY TO DAY LIFE: Strong experience in process validation and quality validation is… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in the implementation and validation of IT systems using best quality practices in compliance with FDA regulations, including cloud technologies and ... is seeking an experienced and dynamic Senior Manager, IS Quality to build and lead our IS Quality...ensure compliance with GxP regulations and industry best practices.System Validation Oversight: Oversee all aspects of computerized system … more
- Merck & Co. (Rahway, NJ)
- …to: Supporting the preparation, review, and approval of documentation related to validation and quality operation of above requirements including core ... required. Ability to understand business needs and map to IT technical solutions. As part of this Quality...comprehension of the current pharmaceutical industry and applicable regulations ( FDA /EU/ICH), with emphasis in 21 CFR Part 11, 210,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance. Essential Functions Reviews all manufacturing and support records to… more
- Sunrise Systems Inc (Warren, NJ)
- …for ensuring quality , integrity, and compliance of site Information Technology ( IT ) systems, review of validation and qualification documents for all ... and compliance. Previous experience as a computer system validation / quality assurance for life sciences...software (eg Veeva). Drives use of best practices during IT systems design, validation , and use. Must… more
- DivIHN Integration Inc (Research Triangle Park, NC)
- …laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation , Facilities and Engineering, and IT . Contacts and obtains technical ... and thermal mapping activities comply with relevant industry regulations (eg, USP, NIST, FDA , GLP, GMP). Minimum Requirements High School Diploma and 9 years of… more
- Novo Nordisk (Clayton, NC)
- …all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT , which globally employ approx. 20,000 of Novo Nordisk's 50,000 ... provide/lead validation services required for the successful delivery of IT & Automation projects. Relationships Senior Project Manager, Site Capacity & Upfit.… more
- Kelly Services (Anasco, PR)
- …the medical device and/or pharmaceutical manufacturing environment in manufacturing process, quality or validation engineering position and preferably with ... for you. How about this one?** We're seeking **Project Validation Specialist** to work with one of out top...Medical Device Directive 2007/47/EC and ISO13485:2016 Medical Devices - Quality Management Systems + Knowledge of FDA ,… more
- Teva Pharmaceuticals (West Chester, PA)
- … validation experience in pharmaceutical industry; knowledge in validation and quality compliance (cGMP/cGLP/ICH/ FDA /USP/EU policies/guidelines) ... and/or with subject matter experts to implement process improvements and optimize key validation and quality initiatives * Support internal and external audits… more
- Bristol Myers Squibb (Bothell, WA)
- …and Engineering, IT , Manufacturing, Quality Control, Supply Chain, Quality Assurance, and Quality Engineering Validation ) to manage workload ... be responsible for the preparation, review, and approval of quality and validation related documentation and ensuring...team. + Stay abreast of all relevant GMP regulations, FDA guidelines, and international standards to ensure lab operations… more
- System One (Somerset, NJ)
- …supplements and OTC products. + Collaborate with cross-functional teams, including Quality Assurance, Production, and Engineering, to support validation ... Title: Validation Engineer Hours: Mon- Fri 8:30-5:00pm Location: Somerset,...actions. System One, and its subsidiaries including Joule, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are… more
- Medtronic (Lafayette, CO)
- …lead a team of Test Engineers to develop and perform verification & validation activities for software and systems to ensure Medtronic's cutting edge medical ... products meet our user's needs and our quality and reliability standards. This position requires technical expertise and provides team leadership to solve complex… more
- ThermoFisher Scientific (Middleton, WI)
- …digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities ... departments and the client to initiate and complete performance qualification (PQ) validation . Facilitates the validation process and implementation of system… more
- Bristol Myers Squibb (Devens, MA)
- …. **PURPOSE AND SCOPE OF POSITION:** The Associate Director, CTF Digital Plant IT Quality at Devens Cell Therapy Facility (CTF) will direct the ... Skills, and Abilities** + Thorough knowledge of regulatory computer system validation requirements including FDA , EMA, and Worldwide Regulatory requirements… more
- IQVIA (Raleigh, NC)
- …of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems, and Technology in general. ... functions on validation of new systems and improvement of existing IT Quality processes/practices. + Provide consistent interpretation and implementation of… more
- Bristol Myers Squibb (Devens, MA)
- …systems (DeltaV, Syncade, PI, Benchtop IT Systems, etc.) at Devens CTF. + Provides IT quality support to Devens CTF Digital Plant team through quality ... implications or cause significant delays in schedules. + Coordinates with higher level IT Quality personnel on decisions and applies appropriate notification to… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Become a **maker of possible** with us. **Our vision for the Director, Quality Assurance at BD** Lead the development, establishment and maintenance of Quality ... and controls during design, development, and transfer; ensuring that performance and quality of new products in Infusion business conform to product requirements,… more
- Medtronic (San Diego, CA)
- … operating methods, processes, and procedures (such as ISO13485/IEC62304/HIPAA/ FDA /Security Standards/Data Privacy)** + Define appropriate metrics to measure ... and validation . + Defines appropriate measures to ensure product quality . + Develops overall operating criteria to ensure implementation of the software… more
- Medtronic (Los Angeles, CA)
- …transitioning development projects to manufacturing across multiple Medtronic sites and quality systems. + Generating master validation plans/reports and design ... validation and reliability demonstration activities. + Assisting Supplier Quality engineering and purchasing teams in vendor development, supplier agreements and… more
- Abbott (Sylmar, CA)
- …certificates, Software validation / Life Cycle management (eg, GAMP 5), IT Service Management certified (eg, ITIL) and Cloud Foundations certified (eg, AWS, ... industry. + ** IT compliance & governance experience.** + Experience with **GxP validation ** and large-scale IT implementations (eg, SAP, ERP, CRM, QSM, Model… more
