analysis programs commonly used in life sciences (e.g. SAS and R). Understanding of epidemiology or outcomes research and the...
. Experience in a manufacturing QC lab environment. Life sciences-specific experience with a strong understanding of data...
Job Description: Qualifications: Bachelor's degree in Quality Management, Regulatory Affairs, Life Sciences...
of GxP activities as per project plan What are the top skills required for this role? Life Sciences Domain knowledge...
Responsibilities and Requirements: Must be from Life science or Pharma domain experience. He should be capable...
Responsibilities: Responsible for the overall development life cycle of the solution and manage complex projects...
throughout the software development life cycle. Prepares validation plans, test cases and validation summary reports... and terminology and solid understanding of the software development life cycle (SDLC) Strong troubleshooting skills...
, or other regulated industries. Demonstrated experience in software quality assurance processes, Software Development Life Cycle (SDLC...
Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical...
life cycle management, considering all relevant guidance, commercial needs, and company objectives. Develop strategic...
Roles & Responsibilities: Master's degree in fields such as outcomes research, epidemiology, biostatistics, data science, predictive analytics or doctoral degree (PhD, DrPH, ScD). At least 5 years of experience programming with R or Pyth...
Responsibilities: Secondary Data Study Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and study report: Supports statistical activities for studies including study design, protocol dev...
Expert in CSA validation principles. Automated testing experience a must Develop a strategy to convert existing CSV approaches to lab validation into a CSA documented process. Developing, reviewing, and executing testing documentation. ...
Develop, validate, and implement analytical test methods for combination products in compliance with regulatory standards and internal quality requirements. Collaborate cross-functionally with device engineers, laboratory teams, and qualit...
CSV for SAP systems/projects To create| assign and track the project [module] work plans for delivery and also provide technical guidance for work completion. (1.) To ensure process improvement and compliance in the assigned module| and ...
Responsibilities: To create| assign and track the project [module] work plans for delivery and provide technical guidance for work completion. Ensure process improvement and compliance in the assigned module| and participate in technical...
Responsibilities: Serve as the primary support for the MES Syncade system, ensuring its seamless integration with manufacturing processes. Develop a deep understanding of manufacturing workflows to optimize and enhance processes with MES...
Responsible for managing end-to-end CSV deliverables for both new & existing applications. Responsible for Implementation of Lab, Enterprise and Manufacturing systems and supporting change management of existing systems. Manage and suppor...
Responsibilities: Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems. Author validation protocols ensuring that the technology solutions...
Responsibilities: Provides SAS programming support to all clinical studies. Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables. Provide statistical programming support for regulatory su...