Qualification (PQ): Develop documents as coordinator/owner according to Takeda procedures, execute, and complete PQ protocols... protocols on time according to project schedule. Execution of PQ: Complete execution of PQ protocols on time according...
safety perspective. Support contract manufacturing in performing equipment IQ, OQ, and PQ. Maintain and update packaging... to provide technical solutions. Proficiency in SolidWorks to create packaging concepts and drawings. Experienced with IQ/OQ/PQ...
. Advanced knowledge and experience with IQ, OQ, and PQ validation, DV and TMV testing of medical devices including creating...
and implement long-term corrective and preventive actions (CAPAs). Support installation, qualification, and validation (IQ/OQ/PQ...
and reliability. Provide metrology expertise for new equipment installations, commissioning, and qualification (IQ/OQ/PQ). Participate...
including URS, FRS, IQ, OQ, and PQ. Support production planning, process orders, batch management, quality inspections...
Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring... and documentation practices. Roles & Responsibilities: Develop and maintain IQ/OQ/PQ documentation for AWS infrastructure components...
Summary : Validate CNC equipment and related processes used to manufacture medical devices. Focus: Ensure IQ/OQ/PQ...), and PQ (Performance Qualification) protocols and reports. Lead Master Validation Plan, risk assessments (FMEA), and ensure...
protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports...
PQ submissions as required. Serves as representative to gather and interpret new and changed regulations and guidelines... submissions (Pre-submissions, 510(k), De Novo, PMA, IVDR Class A, B, C or D or WHO PQ). Critical review of study protocols...