- Insmed Incorporated (San Diego, CA)
- …11, GAMP 5, Good Clinical Practices, GMPs, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing ... Preferred Skills, Experience and Education): 7+ years' hands-on experience in a validation role with responsibility for computer systems specifically LIMS,… more
- Syner-G BioPharma Group (Boston, MA)
- …the biotech, pharmaceutical, or medical device industry.Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in ... information, visit www.Synergbiopharma.com (Syner-G is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : Syner-G is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, ... assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification,… more
- Cipla (Hauppauge, NY)
- …orders, protocols, reports. Perform gap assessments and remediation as required on legacy validation packages. Interface with the FDA and customers during site ... Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location :...pharmacy) or a related field. Must be proficient in computer skills and software applications such as Microsoft Office… more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... leads. + Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. +… more
- Curia (Albuquerque, NM)
- …and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), environmental ... mapping and use of Kaye Validator + Experience with FDA and EU regulations for pharmaceuticals and validation...form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong… more
- ValSource, Inc. (Rahway, NJ)
- …regulated projects. Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering ... Regulatory Compliance: Ensure compliance with all relevant regulatory standards, including FDA , GMP, and ICH guidelines, during on-site validation . Prepare… more
- Insmed Incorporated (NJ)
- …Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing ... process) Who You Are:5+ years' experience in a management validation role with responsibility for computer systems...a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and… more
- Caris Life Sciences (Irving, TX)
- …Supports the authoring and reviewing of pre-defined deliverables as identified in the Computer System Validation Process and applicable Software Validation ... internal SOPs, Quality System Requirements which include ISO 13485, FDA QSR, IVDR, SOX, SOC2, and IEC 62304 +...lead auditor to ensure the supplier's software development and validation practices comply with Caris's Computer System… more
- Insmed Incorporated (NJ)
- …an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage ... and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech,… more
- Insmed Incorporated (NJ)
- …with Veeva QualityDocs /QMS is preferred.Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.Basic understanding of ... Who You Are:3+ years' hands on experience in a validation role with responsibility for computer systems...processes is preferred.Solid working knowledge of CSV guidelines and FDA /EU regulations: 21 CFR Part 11, Annex 11, GAMP… more
- Merck & Co. (Rahway, NJ)
- …of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness:Lead the cross-functional Device Working Groups… more
- Integra LifeSciences (Princeton, NJ)
- …environment monitoring + Water system monitoring + Bacterial endotoxin test method validation and monitoring + Bioburden test method validation and monitoring ... validation and dose audit management + Ethylene oxide sterilization validation and requalification + Reprocessible device cleaning and sterilization validation… more
- Endo International (Rochester, MI)
- …of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and ... for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Senior...of information required for the job_ _e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Has… more
- Novo Nordisk Inc. (Boulder, CO)
- …production. Routine interactions with analytical development for implementation and validation of analytical methods. Essential Functions Requires full-time, on-site ... TOC, endotoxin, and FTIR Work closely with Analytical Development on method validation protocols and execution relevant to product methods Routine analysis of raw… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strongly preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System ... manufacturing and protocol-driven activities such as tech transfer and process validation .Assist in the development of process, operational, and quality improvements… more
- Cipla (Fall River, MA)
- …controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management ... approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents,… more
- Cipla (Central Islip, NY)
- …Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, Validation protocols/reports. Conduct focused time-studies to support packaging ... investigations, Corrective Action Preventive Actions (CAPAs), change controls and validation activities as required. Apply complete knowledge of process improvement… more
- Curia (Albuquerque, NM)
- …and collaborate closely with cross-functional teams including Production, Maintenance, Quality, Validation , and Supply Chain. In addition, the candidate will provide ... performance. + Collaborate with cross-functional teams (Production, Maintenance, Engineering, Validation , and Quality) to ensure smooth operation and compliance with… more
- Teleflex (Olive Branch, MS)
- …on trends. - Process Validations - guide and review protocol development, validation implementation and report review an acceptance; - Quality & Cost Improvement ... compliance with Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus. - Documentation Control… more
