cGxPServe

Job Description: Are you a skilled Senior Project Manager with deep experience in delivering complex crossfunctional projects in regulated industries Were looking for a proven leader to guide the implementation of the Apriso MES system enabling digital transformation at a steriliza More...

Job Description: Performs machine operation under minimal supervision including basic inspecting while working safely and efficiently. While using standard operating procedures applies basic knowledge and techniques to complete routine task and process requirements. Develops skills in More...

Responsibilities: Leads performs and oversees data management activities for clinical studies and/or clinical programs. Performs handson clinical data management tasks to support clinical studies including but not limited to: reviewing study protocols designing eCRFs performing and c More...

Job Description 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 clin 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...

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...

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...

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...

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...

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: Develops and improves manufacturing processes by studying product and manufacturing methods. Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design fabrication assembly tooling and materials; conferring w 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 Client packaging proces More...

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

Job Description: The Facilities Suite & Elastomer Maintenance Mechanic Level III provides support to the Engineering Services group by operating and performing daily checks on Direct and Indirect Maintenance equipment/systems and assists higher level mechanics with repairs in complia More...

Job Summary: We are seeking an experienced Lead Clinical Data Manager to oversee and manage all aspects of clinical data management activities for multiple clinical studies. The ideal candidate will ensure the accuracy integrity and quality of clinical trial data while collaborating More...

Responsibilities: We are seeking a dedicated Regulatory Affairs Specialist to manage and coordinate our regulatory submission processes. This role offers the flexibility of being fully remote or hybrid catering to your worklife balance needs. work hours: 8am to 4pm. Coordinate and p 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...