cGxPServe

Roles & Responsibilities: Plans and coordinates distribution of goods to ensure that current inventory levels are within set parameters to meet customer demands. Plans and forecasts for future inventory levels based on sales forecast current inventory levels and outstanding purchase More...

Responsibilities: Lead the design development and maintenance of the MHN Analytic Platform. Manage mentor and ensure technical and analytical development of a team of analysts. Work with teams to operationalize analytic and reporting innovations. Evaluate BI and machine learning solu More...

Roles & Responsibilities: Perform all routine tasks to convert planned orders into material plans including the creation and management of material planned requirements. Liaison with Supply Planner and Schedulers to ensure all material plans are up to date and responsive to changes More...

Responsibilities: The senior programmer position will be responsible for manipulating large databases and generating reports to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS and SQL programming skills and the ability to implement co More...

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout Modeling and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / U More...

Responsibilities: Responsible for the oversight of all data management CRO activities supporting companys clinical programs from database startup through database lock and CSR/submission. Serves as primary point of contact with the DM CROs 3rd party vendors and internal study teams. More...

Job description: Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to determine conformance to specifications. Acts as a More...

Position Overview: Looking for an individual with experience in validations particularly with USP Water chiller (utilities) and C&S. Responsibilities: Generation of qualification / validation documents of qualification / validation documents generation of reports adhering to proj More...

Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic subm More...

Responsibilities: Duration: 12 months contract extendable up to 36 months. The Client team is seeking a Regulatory Affairs Specialist to contribute to the development and of effective regulatory strategies for investigational products. The successful candidate will serve as a regula More...

Responsibilities: Provide quality oversight for commissioning qualification and validation of manufacturing and lab systems. Review and support investigations for deviations related to equipment utilities automation and lab instruments. Review/approve change controls and risk assess More...

Responsibilities: The SAS/Statistical Programmer will be responsible for providing programming support for clinical trials conducted within the pharmaceutical industry. The successful candidate will work closely with the Biostatisticians Data Managers and Clinical Research teams to d More...

Overview: Manufacturing Engineer will interact with Opco partner and get necessary information to perform the task and deliver output. He / She should interpret the product process requirement and create work instruction for weld shop / assembly of production lines. He / She should More...

Responsibilities: Develop test and validate SAS programs to generate analysis datasets (ADaM) TLFs and adhoc reports. Ensure datasets and outputs adhere to CDISC standards and regulatory guidelines (e.g. FDA EMA). Collaborate with Biostatisticians Data Management and Clinical Teams More...

Responsibilities: Lead the validation team in a strategic riskbased approach that optimizes legacy Computer System documentation CSA strategies and strong SAP ECC>S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review approva More...

Responsibilities: Research & Monitoring Proficiency. Ability to synthesize large volumes of information into concise actionable insights. Ability to create reports and alerts for crossfunctional teams. The Sr Associate Regulatory Intelligence role performs monitoring and analysis of More...

Responsibilities: Main responsibility includes design of Case Report Forms development of edit check specifications creation of test scripts and testing of study database query processing data reporting putting in place data management plans timelines and manage multiple projects th More...

Job Description: The Analyst Field Planning & Analytics is a role which will aid in data analytics and process reporting to help drive initiatives and strategy for Field Programming. The Analyst will work collaboratively with our field and marketing colleagues as well as home office More...

Job description: Our client is seeking a Temporary Attorney to join our legal team in support of our Cell & Gene Technologies (CGT) platform. This role provides general legal counsel with a focus on complex commercial agreements compliance and daytoday operational matters for a dynam More...

Responsibilities: Strong knowledge of PIMS (Process Information Management Systems) preferrable Aspen IP.21. Experience integrating PIMS systems with various other OT systems (ex. Automation/Controls systems). Experience with OPC communication and SQL is preferred. Support the imple More...