cGxPServe

Job Description: Bs degree with 10 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 others. K More...

Responsibilities: Participate in clinical meetings with Sponsor and KPS personnel as required. Take necessary actions to ensure data management deliverables are met. Establish rules and procedures for secure and responsible data sharing with executives. Manage data management resourc More...

Roles & Responsibilities: Develops and Executes Process Validation Strategies Creates plans protocols (IQ OQ PQ) and risk assessments to ensure effective processes for medical devices and equipment. Ensures Regulatory Compliance Adheres to FDA (21 CFR 820) ISO 13485 and other relevan More...

Roles & Responsibilities: 5 to 6 years of medical device Supplier Quality experience. Experience in Interacting with US & Overseas supplier. Experience in Supplier Evaluation & Onboarding. Experience in Supplier audits. Experience in FAI Component qualification for components receive More...

Job Description: Documenting and validating instrument software per EMA guidelines. Migrating instrument software management into PPD IT SOP frameworks. Capturing requirements configurations and compliance documentation to ensure end-to-end traceability and regulatory compliance. R 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: The Risk Management Owner is responsible for leading and maintaining the fist management process for medical devices throughout their Lifecycle. This role ensures compliance with ISO 14971 FDA QSR EUNDR and other applicable standards. The Risk Management Owner collabo More...

Responsibilities: The Associate Regulatory Affairs Manager will support the development review and submission of regulatory documents for medical device and IVD products. This role will assist in managing regulatory projects ensuring compliance with FDA ISO 13485 and other global reg More...

Responsibilities: The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design manufacturing and sales of medical devices (including Class I and II devices software as a medical device a 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: Provide subject matter expertise on validation project risk and complexity. Ensure adherence to validation best practices and compliance standards. Gather project information and requirements from system stakeholders. Collaborate frequently with Business Analysts an More...

Responsibilities: This role is responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data sets for one or more compounds/indications or therapeutic areas. This role must effectively interface with team members fro More...

Job Description: As Qualification Specialist in the Equipment Integration team you are responsible for caring about the GMP requirements. The team is responsible for transferring existing Lab Equipment form Spark Network to Roche Connect Network (RCN). Including replacing the HW OS a More...

Responsibilities: The Clinical Data Manager actively participates in all aspects of the data management process from the development of project documentation system set-up User Acceptance Testing (UAT) and routine data review through database lock of clinical trials. The CDM has a br More...

Responsibilities: This person will be responsible for development and generation of analysis datasets tables listings and graphs from assigned clinical sources using SAS and/or R; leading development and maintenance of associated operating procedures; and participating in external in More...

Responsibilities: You are responsible for managing our Regulatory Affairs for the US facility and fulfill US Agent responsibilities for all foreign Siegfried sites. Additionally you will be managing all drug master files for the US facilities and maintain FDA Drug Registrations FDA S More...

Responsibilities: Remain onsite and embedded with the C&Q team on Line 8 to provide real-time support during commissioning and qualification activities. Act as the Cognex Vision Systems SME supporting setup configuration calibration and troubleshooting. Collaborate with the Automatio More...

Responsibilities: The Senior SAS Programmer / Statistical SAS Programmer is responsible for providing programming support for clinical trials and contributing to the development of departmental standards. This includes developing and validating SAS programs for statistical tables dat More...

Job Description: Under the general supervision of the Quality Manager perform electrical mechanical and visual inspections on in-process products and finished goods according to documented test and inspection methods to assure product safety and compliance to specifications GMPs and I More...

Job Description: We are seeking a highly skilled Lead Clinical Data Manager to join our team on a contract basis. The ideal candidate will have extensive experience in Clinical Data Management (CDM) within the Medical Device or Pharmaceutical industry with deep expertise in Medidata R More...