cGxPServe

Roles & Responsibilities: Bs degree with 9 years experience in Supplier quality from aerospace / automobile / medical. Experience in PPAP / APQP and new product development and CAPA. Supplier audits and new supplier onboard. Knowledge of quality tools such as 7 QC tools MSA SPC and o More...

Responsibilities: Lead the design of data collection and management systems and initiate process improvements as needed. Establish goals timelines and deliverables for data management of trials and oversee priorities and timelines for all data staff to provide cohesion across s More...

Job Description: We are seeking a detail-oriented and proactive contractor to support our Research & Development (R&D) team in documenting and standardizing key operational processes. This position plays a vital role in enhancing internal efficiency ensuring compliance and promoting More...

Responsibilities: Act as the point of contact for DM activities for multiple trials provide oversight of data collection and management per regulatory and industry standards. Provide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial More...

Responsibilities: Primary - Review and process first part approvals for Customer New Product Development (NPD) initiatives including development review and submission of all required supporting documentation. Work with Customer facilities as required to achieve acceptable outputs fro More...

Job Description: The Sr. Manager Regulatory Affairs for Getinges Endovascular product area within our global Acute Care Therapy business area will be responsible for partnering with R&D and Marketing as well as other cross-functional team members to develop and implement global r More...

Job Description: This role supports the Market Research (MR) Compliance and Operations Team under direction and guidance from the MR Compliance Lead. The coordinator works cross-functionally supporting Analytics activities related to Market Research and GVP Activities to ensure that i More...

Job Description: The Equipment Validation Specialist is responsible for ensuring that all critical GMP equipment and systems used in manufacturing are validated maintained and compliant with regulatory requirements. This role supports manufacturing operations by providing documented e More...

Responsibilities: Lead the development and implementation of submission-ready SDTM datasets in accordance with regulatory requirements (e.g. FDA EMA PMDA). Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. P More...

Job Description: Responsible for planning writing implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems. Serve as the CSV subject matter expert and provide guidance on and interpretation of global GxP guidance and regulations of computerized More...

Roles & Responsibilities: Lead design configuration and commissioning of DeltaV and PAS-X automation systems for GMP-critical manufacturing equipment and process controls. Support change controls deviations and CAPAs involving DeltaV and PAS-X logic batch strategies and alarm configu More...

Job Description: Design develop evaluate or improve assembly systems or related processes including human work factors quality control inventory control material flow cost analysis and production coordination. May work with commercial or industrial designers to refine process designs More...

Responsibilities: Support the plant manufacturing effort with ability to identify problems and specific focus will be in areas of improving quality waste and equipment efficiencies. Application of Transfer functions during troubleshooting and production support (i.e. Statistical Tole More...

Job Description: The Lead HR Generalist reporting to the Sr. HR Manager is responsible for delivering the end-to-end Human Resources agenda for assigned departments and functions at the site. The role involves implementing and maintaining procedures and programs for site employees in More...

Roles & Responsibilities: Were looking for an individual with experience in validations particularly with USP Water chiller (utilities) and C&S. Experience with drafting and executing IQ/OQ/PQ. CAD proficiency to support the update of various P&IDs. Problem solving and troubleshootin More...

Job description: The Biologics CMC Developability team is an integral part of the Biologics CMC Drug Product Development Org. The Biologics CMC Developability team is responsible for- (1) the identification of biophysical- and chemical liabilities in discovery-stage biologic drug cand More...

Roles & Responsibilities: Will be responsible to work in a team atmosphere on 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. More...

Responsibilities: Act as the point of contact for DM activities for multiple trials provide oversight of data collection and management per regulatory and industry standards. Provide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial More...

Responsibilities: Development of engineering Bill of Materials (BOM) in ERP management software. Identifying and quoting manufacturing methods and new materials with suppliers. Monitoring ordering and receipt of materials ensuring compliance and documentation. Coordinating engineerin More...

Job Description: As a Quality Engineer II you will be a key contributor to the implementation maintenance and continuous improvement of the Quality Management System (QMS). You will collaborate cross-functionally to ensure compliance with regulatory requirements drive root cause inve More...