- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Unither Pharmaceuticals (Rochester, NY)
- …high level of confidence with product results. Provide access management for each computer system, while ensuring data handling and data integrity meet internal SOP ... and FDA requirements. This position is partnered with the laboratory...the QC group Verify and sign vendor qualification protocols, validation reports and metrological reports Write requalification paperwork Follow… more
- Curia (Rensselaer, NY)
- …FLP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation , including a minimum of 2 years supervisory experience + ... team resources + Expert in cGMP, USP, EP and FDA regulations Knowledge, skills and abilities + Ability to...interpretation of all lab techniques + Proficient use of computer software, including Microsoft Office Suite (excel, word) and… more
- Curia (Albany, NY)
- …the operational excellence; * Establish and maintain an efficient and compliant validation program including computer software validation and instrument ... well as the review of SOPs, investigations, specifications, methods, validation reports, and analytical reports; * Along with the...instruments, such as UV-VIS, UPLC, and HPLC; and * FDA and Good Manufacturing Practice (GMP) regulations. OR A… more
- Contract Pharmacal Corp (Hauppauge, NY)
- …include, but are not limited to: + Knowledge of USP and FDA requirements. + Develop stability-indicating methods for Active Pharmaceutical Ingredients (API) and ... Dietary Supplement products. + Generate method validation protocols. + Execute methods validation and methods transfer. + Generate method validation reports… more
- University of Rochester (Rochester, NY)
- …of current Good Manufacturing Practices (cGMP) as defined in 21 CFR FDA regulations and apply those to the procurement, handling, inspection, storage and ... in existing systems and procedures. + Execution of I/O/PQ and Production Validation Protocols for packaging equipment. + Provide quality, timely, consistent clinical… more
- Jabil (Elmira, NY)
- …equipment associated with product launches. + Coordinate and support equipment and process validation lifecycle elements such as computer system validation , ... trending. + Gain exposure to concepts of GMP/GXP as well as introduction to FDA , ISO, Safety, and Environmental regulations. + Act as team member supporting capital… more
- Contract Pharmacal Corp (Hauppauge, NY)
- …best practice standards. + Collaborate with Facilities Maintenance, Engineering, Validation , and other cross-functional teams to coordinate activities related to ... manufacturing environment. + Experience with equipment installation and relevant engineering/ validation tasks. + Familiarity with financial aspects of project… more
- Sumitomo Pharma (Albany, NY)
- …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
- Adecco US, Inc. (Buffalo, NY)
- …and the general public. **Skills/Technical Skills** + Communication Skills + Computer skills required, including Microsoft Office Applications, Lotus Notes, Graphic ... E-mail, and other related task-specific software. + Product design and validation , Solid Works, 6 sigma, Minitab/Excel, Project Management Professional, Root Cause… more
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