cGxPServe

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...

Job Description: The Clinical Data Manager (CDM) is responsible for the oversight integrity and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate consistent and meets regulatory and protocol-specific requirements. This role col المزيد...

Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation to compliant to MDD and EU MDR. Defining worldwide regulatory requirements are necessary for regulatory approval of products. Participating in cross functional team المزيد...

Job Description: The Senior Supplier Quality Engineer will support External Manufacturing and Supplier Quality functions by executing both strategic and tactical quality activities. This includes base business support nonconformance (NC) root cause investigations and driving qua المزيد...

Responsibilities: Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with Emmes SDTM Implementation Guide project standard المزيد...

Job Description: Will be responsible to work in a team atmosphere on the production of medical equipment spare parts and accessories in accordance with quality specifications. Works within clearly defined SOPs and adheres to quality guidelines. High school diploma or equivalent. Zero المزيد...

Job Description: Experienced Component Engineer with strong expertise in equipment and process validation including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ). Proven ability to manage component selection supplier coordination and المزيد...

Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labelling project المزيد...

Responsibilities: The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials. This role is key to implementing programming standards and supporting the standardization of CDISC-compl المزيد...

Roles & Responsibilities: 7-10 years experience in Computer System Validation of SAAS systems and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like المزيد...

Job description: The Laboratory Coordinator will develop and administer various laboratory equipment support functions throughout AbbVie R&D sites. This position involves serving as liaison among internal AbbVie personnel as well as external organizations to aid in equipment selection المزيد...

Job Description: We are looking for a Validation Specialist IV who will lead validation and compliance activities for computerized systems analytical instruments and enterprise software. This includes supporting system implementation upgrades administration and retirement while ensuri المزيد...

Job Description: Ensures through global and local Product Development Process procedures and efforts that product software are developed tested and transferred according to established procedures that will assure that they meet all quality requirements. Responsible to assist in the m المزيد...

Job Description: Reporting directly to the division Sterilization Quality Engineer Lead this position involves support for the sterilization operations and product sterility assurance program. This position provides quality guidance for product and process sterility product resolutio المزيد...

Responsibilities: The Sr. SAS Programmer will be responsible for statistical programming for the clients clinical studies. In this role you will develop and validate SAS programs for data presentation analyses and provide programming support to project team members. Our Ideal candida المزيد...

Job Description: The role will include managing OEM Packaging opportunities for distributed products and / or development of sterile and non-sterile case and tray packaging for spinal implants and instruments. This includes the Design History File documentation to support the developm المزيد...

Responsibilities: The Regulatory Coordinator is responsible for the coordination preparation and maintenance of regulatory documentation and compliance for clinical trials. This role ensures adherence to local state and federal regulations including but not limited to FDA ICH and GCP المزيد...

Responsibilities: Clinical Data Manager providing oversight to ensure complete accurate and high-quality data collection for outsourced and in-house trials. Establish and maintain strong relationships with internal cross-functional teams vendors and clinical research site personnel f المزيد...

Responsibilities: The Associate Regulatory Affairs Manager will support the development review and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulatory projects ensuring compliance with FDA ISO 13485 and other global reg المزيد...

Roles & Responsibilities: Develop new processes assess and document new and existing processes of high-volume automated Injection Moulding. Implement and evaluate changes to existing processes designed to improve product quality productivity and overall equipment efficiency. Develop المزيد...