806 Job openings in Cgxpserve
Job Description: What are the top 3-5 skills experience or education required for this position. Process and Cleaning Validation Experience. Equipment Qualification (IOQ/PQ). Quality System Experience (Veeva Track wise Compliance Wire). Medical Device or Pharmaceutical Experience Req More...
Job Description: The Packaging Operator is responsible for performing packaging functions such as filling labeling packing and wrapping containers while ensuring compliance with cGMP guidelines. The role involves executing batch record instructions maintaining accurate documentation s More...
Responsibilities: Provide leadership strategic planning direction and implementation of clinical systems for data collection which may include vendor selection budgeting resource planning vendor oversight EDC build and study timelines etc. Perform or provide oversight to staff for al More...
Responsibilities: The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS) Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products including regulatory responsibilities in associated change control an More...
Responsibilities: Provides Quality Assurance support to Customer and internal functions including Manufacturing Assembly and Test. Work cross-functionally with Engineering Operations Customer and Suppliers. Support internal non-conforming material control process including Material R More...
Responsibilities: 6 to 8 years of SAS programming experience preferably in UNIX environment supporting clinical trials data analysis. Enterprise Guide experience is a plus. Solid CDISC Standards knowledge 8 years of ADaM and TLF programming experience supporting safety and efficacy a More...
Responsibilities: Prepare review and submit regulatory documents to FDA. Manage and oversee the regulatory submission process ensuring timely and successful clearances/approvals. Ensure that all products comply with applicable regulatory requirements including FDA regulations and ISO More...
Responsibilities: Lead the data quality evaluation by investigating all clinical and operational data evaluating trends deviations using visual analytics tools and ad hoc reports. Manage high complex studies and support specific activities of studies managed by other data managers or More...
Responsibilities: Ensure design control compliance and maintain Design History Files (DHF) for new product development. Review and approve design documentation risk analyses (dFMEA uFMEA pFMEA) and verification/validation protocols. Support change control impact assessments and DHF u More...
Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation review completion and delivery of statistical programming activities and deliverable More...
Job Description: Our client a leading medical device manufacturer is seeking a Product Development Engineer to join their dynamic R&D team. This individual will play a critical role in the design development and validation of innovative medical devices that improve patient outcomes. More...
Responsibilities: Authoring editing and executing technical commissioning qualification and validation documentation for standard equipment/systems/ software and processes as part of team as directed by the project leader. Running test scripts and documenting results. Adherence with More...
Responsibilities: Collect enter and manage clinical trial data using electronic data capture (EDC) systems. Perform data validation and query management to ensure data quality and compliance with study protocols. Assist in the development of case report forms (CRFs) and data manageme More...
Responsibilities: Provide comprehensive quality support for operations and NPI activities ensuring compliance with ISO 13485 (or AS9100/IATF 16949) and FDA CFR820 standards. Lead and document root cause analyses CAPA and nonconformance investigations for customer complaints supplier More...
Job Description: We are seeking a talented and detail-oriented Scientific Content Developer to spearhead a critical R&D initiative. The successful candidate will be responsible for creating a internal playbooks a comprehensive guide that documents our cutting-edge scientific methodo More...
Job Description: Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer Activities. Also participate in quality testing for customer in-process final pr More...
Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation review completion and delivery of statistical programming activities and deliverable More...
Responsibilities: As a Senior Statistical Programmer you will leverage your advanced SAS. programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. Performing data manipulation analysis and reporting of clinical tri More...
Responsibilities: The Senior Manager Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring compiling and management of CMC sections for global regulatory filings. This role requires a strong understanding of the drug developm More...
Job Description: We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems combined with technical writing/documentation skills. This role is critical in ensuring compliance validation and accurate documentation of enterprise applications part More...
