OVERVIEW: The CSV (Computer Systems Validation) Manager, Trial Interactive leads and advances TransPerfects global Life Sciences compliance initiatives, including 21 CFR Part 11, GCP/ICH requirements, and the companys ISO 9001-certified Quality Management System (QMS). The role holds direct
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually
Mechanical Associate - Mannitab Plant LOCATION: Ingredion Malegaon,Nashik Plant REPORTS TO: Maintenance, Reliability & Utility Specialist DIRECT REPORTS: Fitter & Helper SCOPE: To ensure efficient operation, upkeep, and continuous improvement of plant utilities and equipment, enabling
At ALS, we encourage you to dream big. When you join us, you’ll be part of a global team harnessing the power of scientific testing and data-driven insights to build a healthier future. Job Description Job
Job Description JOB Responsibilities: • Responsible for compliance with cGMP and related elements like facilities, documentation, trainings, reports, records during manufacturing operations. Preparation and Review of GMP documents related to Mammalian and Drug Product Manufacturing Department.
Job Overview: Responsible for creation/revision/compilation/approval of Specifications/Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable. Summary of Responsibilities: These statements are intended to describe
About the Role: We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our
Agile Dev Team Members have collective responsibility for the design, development, testing and/or deployment of system functionality. Provides guidance, mentorship and training to a direct reporting staff of Agile Dev team members. Agile Dev Team Member V
Job Summary Agile Dev Team Members have collective responsibility for the design, development, testing and/or deployment of system functionality. Provides guidance, mentorship and training to a direct reporting staff of Agile Dev team members. Agile Dev Team
As a QA Qualification Specialist, you will be responsible for supporting, reviewing, and approving qualification documentation for facilities, utilities, computerized systems, and equipment in accordance with GMP requirements, Lonza standards, and governance. You will collaborate with site quality
Role Objective A key objective of this position is to lead and govern the Quality function at the manufacturing site, ensuring uncompromised product quality, patient safety, and compliance with global regulatory requirements (USFDA, EU-GMP, MHRA, WHO-GMP,