cGxPServe

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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 المزيد...

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. المزيد...

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 المزيد...

Job Description: Client is seeking a Verification and Validation SR Engineer to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements based manu المزيد...

Responsibilities: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Creates revises and implements quality standards as well as procedures i.e. Standard Operating Procedures (SOPs) etc. for Erbe USAs Quality Management Sy المزيد...

Responsibilities: Leads the statistical programming activities for projects with lower complexity. Leads the statistical programming activities for studies. Develop SAS programs for the creation of Adam data sets following CDISC standards. Develop SAS programs for the creation of Tab المزيد...

Job Description: We are seeking a highly skilled Bioinformatics Data Analyst to join our team. The ideal candidate will be responsible for retrieving managing and visualizing large datasets while developing custom applications and the integration of laboratory equipment. Responsibilit المزيد...

Responsibilities: In this role you will perform specialized level work assignments and/or analyses evaluation preparation and submission of documentation for regulatory registration ensuring products and procedures comply with regulatory agency specifications. Supports necessary regu المزيد...

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/ المزيد...

Responsibilities: Collaborate with data managers statistical programmers biostatistics clinical operations and external vendors to review sign off on the data transfer specifications and transfer data from external sources ensuring data is received and validated for data integrity. C المزيد...

Responsibilities: Regulatory Labelling Documentation. Support the creation and maintenance of assigned labeling projects to enable worldwide regulatory submissions. Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labeling projects المزيد...