- Legend Biotech USA, Inc. (Raritan, NJ)
- …, and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation , process validation , equipment, ... technical studies, and any associated documentation in support of computer systems validation , equipment, utilities,...instruments, and equipment used at the site.Develops and evaluates quality processes and system standards to ensure… more
- Cipla (Fall River, MA)
- …documents. Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & e-Log ... Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work...with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive,… more
- Syner-G BioPharma Group (Boston, MA)
- …We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems , and ensure regulatory compliance, empowering our clients ... cGMP Manufacturing within an FDA-regulated manufacturing company.Knowledge of cGxP Quality Systems within an FDA-regulated manufacturing company.Knowledge of… more
- Cipla (Hauppauge, NY)
- …(DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the ... to departmental SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation Master Plan and… 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 ... Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. + Need… more
- Curia (Albuquerque, NM)
- …equipment and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), ... validation protocols for processes, equipment, utilities, and test systems . The role also supports new product introductions, equipment...the review of changes made under the Change Control System from a validation perspective + Provide… more
- International (Elmendorf, TX)
- … systems . Your expertise will directly contribute to the delivery of high- quality , high-performance systems for our next-generation vehicles. This is an ... plans and create innovative test procedures tailored to HVAC and cooling system evaluations + Execute validation activities according to engineering standards… more
- Curia (Albany, NY)
- …Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and ... stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation...Minimum 3 years' experience in quality and computer systems validation and/or information… more
- Curia (Albuquerque, NM)
- …utilities, materials, products, computer systems , quality systems , regulatory submissions, calibration, and validation + Oversee the site's ... Manager, Quality Systems in Albuquerque, NM Build...Manager, Quality Systems in Albuquerque, NM Build your future at...and approval of related records. + Chair the site's Quality System Review Boards and host cross-functional… 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 ... quality strategy for software medical products and computerized systems products. + Able to provide technical leadership and...development and validation practices comply with Caris's Computer System Validation Process. +… more
- Formation Bio (New York, NY)
- …Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for ... enabled development organization, there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy… more
- ValSource, Inc. (Rahway, NJ)
- …and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... projects directly at client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves… more
- Novo Nordisk Inc. (Boulder, CO)
- …QC laboratory Assist with implementation and integration LIMS and other Novo software systems as they relate to Quality Control Create and refine process ... within Quality Control laboratory Demonstrated knowledge of pharmaceutical industry validation requirements as it relates to GMP Quality Control laboratory… more
- Terumo Medical Corporation (Elkton, MD)
- …and effective coordination and/or execution of assigned project activities. + Lead quality system development and implementation throughout product life cycle + ... determine root cause. + Provide training and support for quality system processes and quality ...key medical device related standards including 21 CFR 820 ( Quality Systems Medical Devices), Design Controls, ISO… more
- SanDisk (Milpitas, CA)
- …of NAND operation/test modes to boost performance, endurance, and power. + System /component level testing & validation on test platforms including drive-level ... portfolio of products that are recognized globally for innovation, performance and quality . Sandisk has two facilities recognized by the World Economic Forum as… more
- Infinity Systems Engineering (Colorado Springs, CO)
- …documentation, operating procedures, and system design specifications related to radar systems and subsystems. + Testing & Validation : + Plan, develop, and ... standards, security protocols, and regulatory requirements for radar and defense-related systems . + Support quality assurance efforts and contribute to… more
- SanDisk (Milpitas, CA)
- …HBAs, retimers/redrivers). ** Preferred:** + Strong desire to learn about complex system interoperability, PCIe technology, and enterprise storage validation . + ... portfolio of products that are recognized globally for innovation, performance and quality . Sandisk has two facilities recognized by the World Economic Forum as… more
- Teleflex (Mansfield, MA)
- …standards, procedures and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes. Adhere safety, manufacturing and ... medical device industry preferred - Experience with cGMP, FDA regulations, and ISO Quality Systems , strongly desired - Experience in Lean/Six Sigma techniques… more
- Prysmian (Bridgewater, NJ)
- …improvements wherever necessary. + Directs the implementation and maintenance of the Quality System + Supports the Safety and Environmental Management ... Prysmian is the world leader in the energy and telecom cable systems industry. Each year Prysmian manufacturers **thousands of miles of underground and submarine… more
- AeroVironment (Simi Valley, CA)
- …**Other Qualifications & Desired Competencies** + 2 year technical degree desired; Quality system courses and/or equivalent experience preferred + Aerospace ... and documented system . + Develops and maintains process instructions for quality -related activities + Works on assignments that are semi-routine in nature +… more
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