cGxPServe

Job Description: Responsible for the management and coordination of engineering activities related to CIP (Cleaning in Place) and SIP (Sterilization in Place) with external partners and internal stakeholders. Responsibilities: Review CIP/SIP design. Develop and implement CIP/SIP stra More...

Responsibilities: Team provides customized real-world data and real-world evidence solutions to address the most important research questions across clinical development market access and commercial use cases for our life sciences partners. Independently translate analytic specificat More...

Responsibilities: We are seeking an experienced Quality Engineer to join our team in Worcester MA supporting pharmaceutical biologics medical device and combination product manufacturing operations. The Quality Engineer will be responsible for ensuring compliance with FDA and interna More...

Responsibilities: In this critical role you will lead regulatory strategies product submissions and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA) EU (MDR) China (NMPA) an More...

Job Description: Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to determine conformance to specifications. Acts as a 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: 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 o 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: Ensure proper integration and support of quality regulations: drug biologics device and/or combination products. Assist project teams in planning preparation review and approval of quality documentation. Responsible for implementing and maintaining the effectiveness More...

Responsibilities: Leads all DM lifecycle activities from study start-up maintenance database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP) Case Report Forms (CRFs) CRF Completion Guidelines Edit Checks UAT specificatio More...

Job Description: It would be helpful at first step where we would like to see SQE related activities in their resume then only we can decide to go with initial interview or not. Please get us the resume which has projects that involves SQE activities. The CV needs to have these in the More...

Responsibilities: Evaluates potential new suppliers through technical capability assessments ensuring they meet the companys rigorous standards and can deliver high-quality components and assists in the supplier selection. Executes DFMAT (Design for Manufacturing and Assembly Techniq 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...

Job Description: The Senior Engineer External Manufacturing and Supplier Quality provides strategic and tactical support to External Manufacturing by executing quality activities such as base business support and nonconformance root cause investigation to maintain and improve customer More...

Job Description: The GXP Project Manager will oversee full lifecycle project management for pharmaceutical systems ensuring compliance with GXP and GMP regulations. The role requires expertise in managing multiple priorities and delivering complex projects successfully within regulate More...

Responsibilities: The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies. Primary duties are focused on all QMS related matters pertaining to supplier selection processing supplier change request qualific More...

Job Description: Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to determine conformance to specifications. Acts as a More...

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 More...

Job Description: In this role you will support and manage projects provide medical input on branded and unbranded content and participate in various initiatives. You will represent medical affairs in the Medical Legal and Regulatory (MLR) review process to ensure compliance with indus More...

Responsibilities: Assist in the development testing and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs). Support database setup activities including edit check specifications and user acceptance testing (UAT). Review incoming clinical data for complet More...