Responsibilities: Project specific activities include but not limited to: Lead plan development for US and Canada commercial teams. Work with cross-functional team to determine…
Responsibilities: Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision. Equipment Qualification / Re-Qua…
Responsibilities: Serves as the primary project team representative, delegating work as appropriate. Generates SDTM domains, ADaM data sets, and Define.xml files with proficienc…
Responsibilties: Strong understanding of building systems including life-safety, lighting, mechanical, electrical, plumbing, and HVAC Strong knowledge of critical utility system…
Responsibilities: Develop and maintain global clinical data standards, including operational (eCRF and external), post-process, Study Data Tabulation Model (SDTM), controlled ter…
Responsibilities: Works under general direction to guide design and development of advanced biomedical solutions that are needed to meet key business objectives relating to the e…
Responsibilities: Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities. This role will be respons…
Responsibilities: Basics on python concepts OOPs concepts with example. sample coding test. Decorators with example PyTest framework usage for End-to-end testing Questions o…
Responsibilities: Generate and validate tables, listings, and figures (TLF) based on statistical analysis plan (SAP) Work with statistician to provide statistical analysis suppo…
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health auth…
Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of a…
Roles & Responsibilities: Responsible to create and execute qualification protocols (IQ/OQ/PQ), including identification and resolution of non-conformances/deviations. Responsib…
Responsibilities: 7+ years of experience in Computer System Validation Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full …
Responsibilities: Execute and/or approve deliverables for the Site Validation Plan enabling overall strategic implementation of remediation and qualification activities within th…
Responsibilities: Subject matter expertise (SME) on packaging design for Class II and III medical device, pharmaceutical and combination products. Technical leader of the design…
Responsibilities: Collaborate with project team members to architect solutions per Business Requirements. Perform analysis and design (functional/non-functional) activities to c…
Responsibilities: Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions…
Responsibilities: Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global su…
Responsibilities: Lead statistical programming activities as product lead for full development project or groups of projects in Oncology Therapeutics. Attending multi-disciplina…
Responsibilities: Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, projec…