cGxPServe

Responsibilities: Coordinates design review meetings to review all quality aspects of new products. Interfaces with Product Development Engineers to ensure quality considerations during the concept stage. Support Design Control activities by ensuring compliance with FDA and internati More...

Job Description: The Senior Manager/Associate Director Medical Communications Ad Promo represents the Medical function in the Material Review Process to guarantee medical clinical and scientific data accuracy relevance objectivity balance and alignment with product label. Functions as More...

Job Description: We are seeking a Research Associate III to join our team. This key member of the team will be responsible in designing and executing experiments to support various innovation projects for cell culture media and growth supplement products. Responsibilities: Design a More...

Responsibilities: Provide clinical programming expertise to support clinical trials global filings regulatory queries data collection and cleaning. Provide input from statistical programming to support clinical trials global filings regulatory queries labelling and payer analyses as More...

Responsibilities: The Regulatory Affairs Consultant will be responsible for providing strategic guidance on regulatory requirements and submissions for medical devices. This role involves ensuring compliance with global regulations preparing and managing regulatory submissions and ac More...

Roles& Responsibilities: Responsible for receipt transfer storage maintenance and inventories of samples received for QC including but not limited to raw materials stability inprocess samples and lot release. Perform and support general lab support activities such as housekeeping eq More...

Responsibilities: Lead the preparation review and submission of CMC sections of regulatory filings (e.g. INDs NDAs BLAs MAAs variations renewals) to global health authorities ensuring accuracy completeness and compliance with applicable regulations and guidelines. Provide regulatory More...

Job Description: This is your chance to drive impactful innovation by leading usability studies guiding risk analysis and collaborating crossfunctionally across R&D Regulatory and Marketing teams. Responsibilities: Lead formative and summative usability studies for medical devices. D More...

Roles & Responsibilities: Bachelors degree in mechanical engineering or related discipline or equivalent With Gratitude. Experience in drafting protocols & report generation (including Data Analysis.. Knowledge in Test method development & Validation. Experience to use of statistical More...

Roles & Responsibilities: The Packaging Operator I is responsible for performing on a daily basis all direct and indirect activities assigned to them in the packaging area with the ability to follow both written and verbal work instructions. The tasks required of this position includ More...

Responsibilities: Responsible for data management documentation including but not limited to data management plan(DMP) CRF eCRF design edit check specifications data issue logs and data review plans and ensures all documents follow study design and regulatory requirements. Maintain D More...

Responsibilities: Performs all SAS programming required for clinical trial analysis and reporting. Ensures that activities and processes performed are conducted according to sponsor requirements. Works closely with the Biostatistics and Data Management departments on various clinical More...

Roles & Responsibilities: Previous experience as a Quality Engineer to include: Putting together a Risk Assessment in Pharma Manufacturing and understanding the concept of assessing machinery for potential failure modes and quality issues. Working with automated pharmaceutical manufa More...

Responsibilities: Support activities within MSATUS regarding technical documentation SOPs and internal systems. Development of technical positions regarding packaging and Pharma process equipment material and component performance and Regulatory compliance for Company packaging proc More...

Responsibilities: Conduct electrical mechanical and visual inspections of raw material components inprocess products and finished goods following documented methods to ensure product safety and compliance with GMPs and ISO standards. Inspect incoming goods to verify quality and accu More...

Job description: This role supports the Quality Control Environmental Monitoring team in maintaining the cleanrooms for commercial manufacturing and environmental monitoring performance qualifications. This role will also be central in all processes associated with environmental moni More...

Roles & Responsibilities: 3 years of experience in the Pharma and/or Consumer Health industry. Strong understanding of regulatory requirements and industry standards. Previous experience in Document Management systems (e.g. Veeva Documentum Enovia) to create store and manage document More...

Responsibilities: The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for More...

Job Description: We are seeking a highly motivated Research Associate to join our team on a contract basis to support key cellular and biochemical studies. The contractor will be responsible for the isolation and characterization of primary human (and occasionally monkey) blood cells More...

Roles & Responsibilities: Experience with and expertise in designing and configuring workflows and implementing ARAVO thirdparty risk/performance management product solution. Implementing the workflowlevel system configuration and unit testing including enhancement and future de More...