cGxPServe

Roles & Responsibilities: 10 years Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems Product Serialization systems MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowle More...

Job Description: This position reports to the Director Global PV Quality Assurance and frequently interacts with cross-functional teams. This role is a member of the GVP QA team providing Quality oversight of global post-marketing pharmacovigilance system including clinical safety fu More...

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 More...

Responsibilities: Follow all company safety rules regulations and job safety analysis. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including but not limited. Discarding obvio More...

Responsibilities: Verification & validation Engineer will have the following responsibilities: A strong technical background and experience g in the medical device industry (Translation of User/Business Needs to System Requirements Requirements Management System Architectural Develop 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: This role participates in the recruitment and screening activities to ensure successful enrolment of volunteers into studies scheduled at the Phase 1 Unit. Interfaces with research participants to support efforts to determine eligibility and consenting of study part More...

Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards regulatory requirements and statistical instructions. Develops and/ More...

Responsibilities: We are seeking a highly skilled and motivated Imaging Scientist at Scientist I level to join our Immunology Department. The successful candidate with a demonstrated ability to work in a matrix environment will work to develop and support small animal imaging project More...

Responsibilities: Ensure departmental or functional training plans in place and appropriate. Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget. Generate validate and/ More...

Responsibilities: Serve as the main contact for service-related inquiries from recruitment managers employees and other HR team members. Ensure the complete resolution of HR requests including tracking and tracing. Offer outstanding customer service by promptly resolving queries and More...

Job Description: We are seeking experienced CQV (Commissioning Qualification and Validation) Validation Engineers to join our team for immediate contract assignments. These roles are focused on the close-out phase of CQV activities for major capital projects within a fast-paced regula More...

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 More...

Roles & Responsibilities: 10 years of experience providing IT support for LIMS systems in a pharmaceutical biotech or laboratory setting. Experience with Lab Vantage LIMS is strongly preferred; experience with Lab Ware LIMS also considered. Strong understanding of laboratory processe More...

Job Description: Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry manufacturing and control (CMC) sections to ensure timely preparation of submission documents. This position will coordinate activiti 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: The MES Engineer will support the implementation maintenance troubleshooting and continuous improvement of Manufacturing Execution Systems (MES) in a pharmaceutical or manufacturing environment. Responsibilities include requirements gathering testing troubleshooting s More...

Responsibilities: Develop and implement regulatory filing timelines for new and existing products in key markets such as US EU and Asia markets. Prepare and submit new global market device applications and amendments. Prepare and oversee the review of Traditional 510(k) Premarket Not More...

Responsibilities: The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) in compliance with current Good Manufacturing Practices (cGMP). This entry-level role involves executing production processes operating and monitoring equipment performing b More...

Responsibilities Follow all company safety rules regulations and job safety analysis. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including but not limited. Discarding obviou More...