cGxPServe

Job Description: The Medical Project Office within Medical Program Management is charged with consolidating and standardizing repeatable activities to ensure high quality consistency accuracy and efficiency. The Manager Medical Ad Board & Symposium Execution is responsible for providi More...

Job Description: We are seeking a highly skilled Equipment and Automation Controls Engineer to join our team. This role involves designing implementing installing analyzing and/or optimizing manufacturing processes procedures equipment and programming. The ideal candidate will also ha 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...

Responsibilities: Lead the development validation and documentation of CDISC-compliant SDTM and Adam datasets for CNS clinical trials ensuring traceability from raw data through analysis outputs. Program and QC tables listings and figures (TLFs) for interim and final clinical study r More...

Job Description: Performs a variety of chemical analyses and GMP review in accordance with cGMP GLP DEA and company policies and procedures. Responsibilities: Perform routine testing (dissolution assay/degradant content uniformity and ID) of drug products in a cGMP laboratory. Comple 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: Develop implement and maintain quality systems and procedures in compliance with FDA EMA and cGMP regulations. Support deviation investigations CAPAs and change control activities. Review and approve manufacturing and quality documentation including SOPs batch recor More...

Job Description: The Hillsboro Innovative Therapies (HIT) team at the client site is at the forefront of bringing new medical advancements from development stages to commercial manufacturing. We work with cutting-edge technologies such as individualized DNA/RNA therapies cell therapi More...

Responsibilities: Provide leadership strategic planning direction and implementation of clinical systems for data collection which may include vendor selection budgeting resource planning vendor oversight EDC build and study timelines etc. Perform or provide oversight to staff for al More...

Job Description: The scientist will be responsible to run in vitro primary cell culture in 96-well plate format perform serial dilutions of drug molecules perform ELISA for cytokine analysis and perform FACS flow cytometry analysis to look at cell populations changes and cell phenotyp More...

Roles & Responsibilities: Mechanical Engineering Degree. Quality Control exposure. ISO 13485 awareness (not mandatory). College Graduate (freshers) to (less than) 10 years of experience. Experience with relevant Supplier Quality requirements is added advantage. Management of supplier More...

Responsibilities: Performing data manipulation analysis and reporting of clinical trial data for both safety and efficacy (ISS/Client) utilizing SAS programming. Generating and validating SDTM and Adam datasets/analysis files and tables listings and figures (TLFs). Production and QC More...

Job Description: Strong written and verbal communication skills. Possess strong analytical and problem-solving skills. Familiarity with one of SAS JMP or Minitab is strongly desired. Working knowledge of MS Office including Office Project software. Six Sigma Process Improvement Exper More...

Responsibilities: Lead projects in manufacturing process areas to achieve process efficiencies such as increase in process yield quality improvements cycle time/throughput and cost reduction initiatives. Gather and analyse process data using statistical process control methodology. D More...

Job Description: The Medical Imaging Specialist is responsible for providing CT and MR imaging expertise for the Intuitive 3D modelling service and operation team. This includes performing initial inspection of CT and MR scans received for 3D model segmentation providing in-process co More...

Job description: This position will play a key role in the development of complex in vitro models to support late-stage internal programs. The ideal candidate will have extensive experience with primary cell culture and complex in vitro models and the potential of applying these model More...

Responsibilities: Position leads complex studies in study design statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health More...

Roles & Responsibilities: Process non-conformances and CAPAs following approved procedures. Perform investigations and assist in problem solving following approved methodologies. Partners with engineering production maintenance etc. to maintain/increase the quality level within the o More...

Responsibilities: Collect enter and manage clinical trial data using electronic data capture (EDC) systems. Perform data validation and query management to ensure data quality and compliance with study protocols. Assist in the development of case report forms (CRFs) and data manageme More...

Position Overview: This position is responsible for reviewing and verifying documentation related to the Initial Sample Inspection Report (ISIR) process to ensure compliance with internal and industry standards. This role works closely with Engineering Quality Sourcing and suppliers. More...