10 Wis Jobs

As a Regulatory Operations Assistant, your role will involve supporting daily operational activities within Regulatory Operations for preparing regulatory submissions required to market pharmaceutical products in domestic and international markets. You will be responsible for maintaining systems to ensure compliance with electronic submission requirements and document management systems. Additionally, you will lead and support the creation, implementation, and maintenance of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and operational processes in alignment with regulatory requirements and best practices. Key Responsibilities: - Serve as a seasoned regulatory o...

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. As a Compliance Associate at eClinical Solutions, you will assist the Sr. Compliance Manager with relevant laws, regulations, and internal policies. Your responsibilities will also include managing the Vendor Intake process, conducting vendor audits, and guiding ot...

The Opportunity: The Senior Manager is responsible for setting strategic goals, managing, leading and developing teams, driving operational efficiency, and making high-level decisions that affect the teams success. In addition, will be responsible for the supervision, critical review, & approval of established US Gx labeling documents filed under an ANDA/505(b)2s while adhering to federal regulations, internal processes, & meeting timelines driven by company goals. Additionally, the Sr. Manager will oversee any/all team databases and trackers. The candidate must possess a firm knowledge of FDA US labeling regulations & guidance for products filed under an ANDA/505(b)2 and should be a SME in ...

About Us Hyva Group is a leading global provider of innovative and highly efficient transport solutions for the commercial vehicle and environmental service industries. The company is committed to the development, production, marketing and distribution of components used in hydraulic loading and unloading systems on trucks and trailers. Its products are used worldwide across a range of sectors including transport, construction, mining, materials handling and environmental services providers. Founded in 1979, the company is headquartered in Alphen aan den Rijn in The Netherlands and operates in more than 110 countries with over 3,500 employees around the world. The Hyva Group encompasses more...

Gurugram Job ID: SS202500088 Function: Lab Testing Role: Lab Desired Skills: Lab Testing, Calibration, Product/Protype Testing,IQ,OQ,PQ,DLP,DGP,5S Job Description Mechanical testing & analysis of products/prototypes ? Test planning & scheduling for multiple projects ? Sample preparation & test equipment setup ? Equipment operation, preventive maintenance & troubleshooting ? Equipment qualification (IQ, OQ, PQ) ? Calibration execution & vendor results review ? Root Cause Analysis (RCA) ? Preparation & review of SOPs, WIs, and test protocols ? Compliance with GLP, GDP & 5S standards ? Safety procedures & hazard control ? Experiment planning & coordination with internal/external labs ? Support ...

We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers. Roles and Responsibilities Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with project teams to resolve discrepancies. Manage scheduling and time constraints across multiple pro...

We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers. Roles and Responsibilities Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with project teams to resolve discrepancies. Manage scheduling and time constraints across multiple pro...

We are seeking a Principal Stat Programmer to join a leading biopharmaceutical solutions organization. This role is for a highly experienced professional who can leverage SAS and other software to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers. Roles and Responsibilities Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets. Ensure outputs meet quality standards and project requirements. Perform validation programming and collaborate with project teams to resolve discrepancies. Manage scheduling and time constraints across multiple pro...

The Opportunity: The Manager is responsible for the supervision, critical review, and approval of established US Gx labeling documents filed under an ANDA/505(b)(2) by US and Mumbai/Bangalore (India locations) members while adhering to federal regulations, internal processes, and meeting timelines driven by company goals. The Manager will also be responsible for their own assignments, when needed, and working closely with other Managers surrounding the review and approval of labeling documents established for these projects. Additionally, the Manager will oversee all team databases and trackers and will update them when changes are required. The candidate must possess a firm knowledge of FDA...

Monitor the production quantity and quality during the product realization. Ensure optimal utilization of resources in plating and strive to exceed the department objectives Ensure QMS & EHS Policies are understood throughout the department Develop and maintain SOPs, WIs, Formats required for the department, along with the team Participate in goal setting process for the department & strive for excellence Develop FMEA, Control Plan and APQP documents related to Plating, along with the CFT Maintain house keeping standards & ensure safety measures PDCA for out of target conditions from DMB, initiate 8D for critical problems / QN's Identification of training needs of Plating department, work wi...