cGxPServe

Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning /sanitizing. Monitor machine functi More...

Responsibilities: Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides as well as FDA guidance and regulation regarding electronic submission of data. Keeps abreast of industry trends in data mapping data management standards complia More...

Responsibilities: Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products registration. Participate on product development teams providing regulatory strategies t More...

Responsibilities: Support the Senior Director in developing and executing regional regulatory strategies for QOL. initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team ensuring alignment with company objectives and regi 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 candidate will have the opportunity to develop and advance AI/ML technologies at the heart of computer-aided drug design. The candidate should have broad experience with computational techniques with a focus on structure-based virtual screening. The key responsi More...

Job Description: Conducting oversight of vendors who identify and collect adverse event and product quality complaint information and complete in-take of Pharmacovigilance safety and product complaint reports in Clients Systems. Conducting oversight of vendors to ensure collection as More...

Responsibilities: Lead the development validation and maintenance of statistical programs using SAS to generate tables listings and figures (TLFs) for clinical trial data analysis. Develop and maintain SDTM domains in accordance with CDISC guidance. Create and optimize ADaM datasets More...

Responsibilities: To support the Biostatistics team by carrying out programming activities of statistical programmers and overseeing external vendors (as required) and to ensure timely and accurate programming and validation activities for clinical studies and publications. Contribut More...

Responsibilities: Represent Data Management in study team meetings providing metrics and guidance on data-related issues. Oversee Data Management activities from study start-up to close-out. Develop and manage study timelines and ensure the quality and timeliness of data from service More...

Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning /sanitizing. Monitor machine functi More...

Responsibilities: Process Validation and IQ-OQ-PQ Experience in medical parts manufacturing experience is the key with process validation expertise around 8 to 10 yrs experience. Protocol Review & Compliance: Study and assess Installation Qualification (IQ) Operational Qualificat More...

Job Description: Self-sufficient go-getter with quality mindset. Associate will be working closely with the supplier quality team to address gaps within supplier quality and distribution systems. They will be expected to pull and review data and work with internal and external group More...

Responsibilities: Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems. Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy chromatography protein analyzers More...

Job Description: Protocol Review & Compliance: Study and assess Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for regulatory and procedural compliance. Process Audits & Documentation: Conduct thorough audits of More...

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and s More...

Responsibilities: Recipe Authoring using Syncade MES. Execute test scripts (design execution simulation wet testing). Own change requests and complete change request tasks to support project completion. Perform change request assessments. Deviations / Root Cause Analysis (RCAs). Assi More...

Job Description: The primary need is help with execution for equipment and process validation protocols. Role will work with the San Diego team and Ireland teams. Ability to manage different time zones and teams is very important. The ideal candidate will have less than 10 years of e More...

Job Description: Working with the Biometrics staff the candidate will provide programming support for Phase 1 to Phase 3 studies. Providing timely support to the project team on all statistical programming matters according to the project strategy. The candidate programs SDTM/ADaM/TL More...

Job Description: Develop and support all Quality Management System (QMS) / Regulatory Affairs (RA) activities and functions supporting the quality goals and quality metrics for site. Responsible for new product setup quality project management and regulatory compliance of serum produ More...