- Daiichi Sankyo, Inc. (Bernards, NJ)
- … system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such as ... Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global...More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification … more
- Merck & Co. (Durham, NC)
- …development and/or maintenance of training programs in the principles of computerized systems validation , computer software assurance, and regulatory ... scope of work. Provide the independent quality approval of key qualification / validation documentation such as policies, procedures, acceptance criteria, plans,… more
- BioAgilytix (Durham, NC)
- …QualificationsCertifications: PMP certification or equivalent project management qualification .Technical Skills: Familiarity with laboratory automation systems ... and ensure seamless integration with laboratory instruments and existing systems .User Acceptance Testing: Coordinate and oversee user acceptance testing (UAT)… more
- Eastman (Kingsport, TN)
- … systems . Responsibilities + Develop 21 CFR Part 11 compliant computer systems validation plans, IQ/OQ qualification test protocols, reports, and all ... Systems across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and Data Integrity requirements.… more
- Catalent Pharma Solutions (Greenville, NC)
- ** Computer Systems Validation Lead** **Position Summary** Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical ... capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Computer Systems Validation Lead provides direct computer … more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the ... , assessing risks involved in processing steps related to equipment, facility/utility and computer systems validation . This role will help develop and/or… more
- Carrier (Beverly, MA)
- …day. Join us and we can make a difference together. **About this role** As a Computer Systems Validation Lead, you will lead and manage the Validation ... Program for Sensitech systems and products. The Validation Lead will work with the Sales, Product, Engineering, and Professional Services teams in the… more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... will work with lab & process automation, large corporate systems , small biotech systems , across all functions...corporate policies and procedures related to all aspects of computer system validation and applicable local processes… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …for process, cleaning, shipping, computer system, equipment and instrument qualification and validation activities + Participate on interdepartmental project ... of validation standards as they apply to facilities, utilities, equipment, computer systems , cleaning and processes. Additionally, person in this role is… more
- Fujifilm (College Station, TX)
- … cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design fundamentals, ... of experience in Pharmaceutical or other regulated Industry. + Experience with qualification / computer validation experience. + Experience with … more
