Job Description: Seeking an experienced Senior GxP Auditor to lead regulatory compliance activities, alignment of SOPs, and bracketing strategy across site and global teams in a highly regulated pharmaceutical manufacturing environment. R...
Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs act...
Responsibilities: Documents and analyses design requirements for implementation. RTL coding, simulating and implementation. Pin assignment based on hardware design. Keeps the HW/SW interface documents up to date. Develops interface an...
Roles & Responsibilities: Prior work experience working in pharma or other GMP setting. Strong working knowledge of analytical laboratory IT systems (i.e. Lab Vantage, Empower, Benching, Signals, L7, LabX, MODA, etc.). Solid knowledge o...
Job Description: A great opportunity for a Validation Engineer II to support QC laboratory equipment qualification activities within a world-class biopharmaceutical environment. This role ensures full compliance with cGMP, corporate qualit...
Responsibilities: Lead CDM activities for assigned clinical studies, ensuring data quality and compliance with study timelines. Design and/or support the design of clinical databases in alignment with study protocols and requirements, in...
Job Description: Responsible for operating machines and performing packaging tasks such as filling, labelling, packing, and wrapping. Follows batch records and cGMP guidelines to support manufacturing, QA, warehouse, and facility operation...
Roles & Responsibilities: 10+years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems. Perform review for GxP systems to ensu...
Job Description: Performs both production assembly operations and complete system analysis, testing and performance optimization. Performs basic electrical, mechanical or software troubleshooting to determine problems in non-functioning te...
Roles & Responsibilities: 7 years of experience in medical device industry . Lead and support design verification and validation activities, including test method development and execution. Perform sample size selection and statistical ...