cGxPServe

Job Description: This position assists in the establishment implementation and maintenance of programs crafted to assure control of processes and products toward established standards of quality. The position uses problem solving techniques to increase quality and efficiency within th المزيد...

Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11 EU Annex 11 and ISO 13485. This role ensu المزيد...

Responsibilities: Develop implement and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software. Support audits a المزيد...

Job Description: We are seeking a Cleaning Validation Engineer with hands-on experience in the startup and validation of clean utility systems such as Water Generation Systems (WFI/RO/DI) Clean Steam Systems Process Gas/Air Systems Distribution Systems Storage Tanks and CIP/COP System المزيد...

Responsibilities: Manage end-to-end delivery of data management services concurrently for single/multi-service projects with little-to-no guidance ensuring quality deliverables on time and within budget to customer satisfaction. Provide comprehensive data management expertise to Clin المزيد...

Responsibilities: Perform validation and QC of the programs datasets and statistical reports per study requirements. Develop and review CDISC SDTM and ADaM mapping specifications. Responsible for study closeout and providing submission-ready statistical programming deliverables to th المزيد...

Job Description: As a Senior Supplier Quality Engineer you have a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDAs Quality System Regulation (QSR) ISO 13485 المزيد...

Responsibilities: Work as an onsite Process Engineer in a process plant environment. Deliver designs and Engineering packages related to process engineering for industrial plants. Define the scope of work discussing with customer coordinate with the offshore team and deliver the engi المزيد...

Roles & Responsibilities: Strong Experience with Test Method Validation and MSAs. Strong Risk Management Experience (Experience in Risk Documentation: Write review approve multiple quality records includes but not limited to: Design Files Risk Management files RPM P1 and P2 calculati المزيد...

Responsibilities: Review and ensure accurate and high-quality statistical programming deliverables from CRO. Perform generation validation and QC/QA of SDTM ADam and TFL output in accordance with SOPs SOIs and guidance documents. Create and maintain specifications as per SDTM/ADaM st المزيد...

Responsibilities: Lead and manage clinical data management activities for oncology clinical trials ensuring adherence to project timelines budgets and quality standards. Provide strategic oversight and direction to CRO clinical data management teams for assigned studies. Develop and المزيد...

Responsibilities: Manage all data management activities according to quality standards and regulatory requirements ensuring adherence to project timelines and budget. Oversee the development of CRFs and CCGs with other functional area representatives ensuring all data management data المزيد...

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 المزيد...

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS SAS/STAT SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM and ADaM standard datasets. Creates and validates tables figures and listings (TF المزيد...

Responsibilities: Prepare and review CMC submission documents registration dossiers health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Responsible for the global regulatory evaluatio المزيد...

Job Description: The Data Manager Data Management Oncology Early Development (OED) is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Ma المزيد...

Responsibilities: Review and validate vendor-provided system documentation for serialization/track & trace systems (e.g. Optel Systech Trace Link). Develop and execute a risk-based validation strategy aligned with company and regulatory standards. Create or refine UAT scripts execute المزيد...

Responsibilities: Under the direction of the applicable management the Clinical Data Manager (CDM) is responsible for executing end to end data management activities pertaining to clinical trials including but not limited to; data management tool and system development validation and المزيد...

Responsibilities: The Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistica المزيد...

Responsibilities: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products. This section cont المزيد...