Life Cycle (SDLC) deliverables of primarily Laboratory Instrument Systems and secondary for Application Systems support GxP... in a health authority regulated (e.g. GxP) environment Industry experience including computer system validation, System Life...
Responsibilities: Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs. Be responsible for overall project delivery, including clinical trial reports and other regulatory submission delivera...
Roles & Responsibilities: Independently draft and execute complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment. Balance competing priorities while ensuring global ...
. Automation experience in the pharmaceutical/life science industry, with a preference for API/bulk manufacturing environments...
Summary: A minimum of 8 years' work experience in GXP / Analytical lab environment. Experience handling medium to complex GMP instruments such as UV VIS, FTIR, NMR, Polarimeter, XRD, HPLC, GC, etc. Ability to manage a support team onsit...
integrity, shelf-life, and transit testing Prepare packaging verification/validation protocols and reports in compliance...
Job Summary We are seeking a Senior Supplier Quality Engineer to join our Supplier Quality Engineering team as a consultant. The role is within the Medical Devices / Orthopedics manufacturing domain, supporting external manufacturing suppl...
Job Description: The Dispensing Technician supports the manufacturing of therapeutic proteins (API) by accurately dispensing raw materials-liquids, powders, acids, and bases-under cGMP conditions. This role requires precision, compliance, ...
Education & Experience : Bachelor's degree (minimum) in Engineering or Biological Sciences 2+years of experience...
, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing...