cGxPServe

Responsibilities: Join a leading biopharma company supporting critical regulatory systems initiatives. Were seeking a detailoriented consultant with expertise in Regulatory Systems eCTD submission management and experience working with global IT and crossfunctional teams to drive sy More...

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems ensuring they are designed validated operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation More...

Roles & Responsibilities: This is an entry level position in a clean environment that requires gown training. Contributes within the team using SAP DMS TrackWise and Syncade systems for receipt storage issuance and allocating components. Demonstrates organization communications and More...

Roles & Responsibilities: ISO 13485 Supplier Quality NC/CAPA Purchasing Control 21 CFR 820 Part or Component Qualification Equipment Verification & Validation activities. Knowledge of Supplier Quality Related activities. Exposure to ISO 13485 / 21 CFR 820 / Purchasing Control. Equip More...

Roles & Responsibilities: Minimum of five 5 years of related work experience as a maintenance planner/scheduler. Minimum three 3 years of pharmaceutical or BioTech industry experience. Proficient in the use of planning/scheduling software: ERP (Oracle/SAP) CMMS (Maximo) and Document More...

Responsibilities: Data preparation and cleaning. Cleaning and transforming raw clinical trial data from various sources to ensure accuracy and consistency for PK/PD analysis. Programming PK/PD analyses. Writing SAS code to perform descriptive analysis of PK/PD data and statistical an More...

Roles & Responsibilities: Will be responsible to work in a team atmosphere on production of medical equipment spare parts and accessories in accordance with quality specifications. Works within clearly defined SOPs and adheres to quality guidelines. High school diploma or equivalent. More...

Job Description: Sr. Quality Engineer will lead a project focused on improving the quality and compliance of the Dispensing Implementation process. This role involves collaborating with the Dispensing Implementation teams to identify document and implement compliancerelated improvemen More...

Job description: As a RealWorld Data (RWD) Scientist you will be part of a team powering data driven insights that lead to better faster decisions and therapies for our patients. Acting as a lead data scientist in your project area you will contribute RWD expertise to broader crossfu More...

Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS SDS and RTM documents. Create review and approve software validation documentation. Create and execute qualification protocols and document reports; review a More...

Job description: As a RealWorld Data (RWD) Scientist you will be part of a team powering data driven insights that lead to better faster decisions and therapies for our patients. Acting as a lead data scientist in your project area you will contribute RWD expertise to broader crossfu More...

Job Summary: The Packaging Technician I is responsible for performing routine bottling labeling and packaging processes according to established procedures and work instructions. He/she must be able to read understand and complete all packaging documentation including batch records st More...

Responsibilities: BS Engineering and 2 years of experience. Drawing and Specification reviews. Manufacturing Process Control Plan reviews. Measurement System Analysis (MSA) Test Method Validation (TMV) reviews. Manufacturing process validation reviews. Manufacturing process capabilit More...

Roles & Responsibilities: Work on QA Vaults for system and process development/refinement. Veeva Vault Quality suite of applications eQMS Quality Docs etc.

Roles & Responsibilities: Bachelors Degree in a relevant field. At least 8 years of relevant experience in data management ideally within clinical trials or observational studies. Perform or oversee data management tasks for global noninterventional observational studies. Handle da More...

Job Description: Engages cross functionally to investigate and document compliance events ensuring timely resolution to enable program timelines. Works with Databases and electronic systems. Follows through with business partners to receive investigation results actions planned and cl More...

Roles & Responsibilities: Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products. This sect More...

Responsibilities: The Data Manager will lead data management (DM) activities for clinical trials including database setup study conduct and closeout. The Data Manager will work collaboratively with a crossfunctional team to maintain project timelines and to deliver highquality DM del More...

Roles & Responsibilities: Bachelors degree in science or engineering (MS accepted PhD is overqualified). Minimum 2 years in Process Validation within the biotech/pharma industry. Writing and executing process validation documents. Strong Process Performance Qualification (P More...

Responsibilities: As a key member of our R&D team youll be responsible for developing and maintaining the embedded software architecture and design for our lifesaving CRRT devices. Youll work collaboratively with crossfunctional teams to create the best solutions possible and mentor More...