and Responsibilities Lead the installation and validation of new equipment/process development through SAT/IQ/OQ/PQ Develop/write...
and improvement Report the identified HW/SW issues during printing to PQ team lead or project manager Ad hoc duties to be assigned...
. Participate in improvement initiatives . Ability to meet qualifications to obtain (one of) CDI, Q, PQ or RI stamps...
processes. Work with QA, Compliance, and Validation teams to ensure required documentation (URS, FS, DS, IQ, OQ, PQ, change...
and prepare technical reports Perform IQ/OQ/PQ and maintain lab equipment Follow safety procedures and good laboratory practice...
validation (IQ/OQ/PQ). Define and generate all required documentation in support of manufacturing protocols, reports, changes...
and Optimize Work Design, Manufacturing Layout and Product Flow IQ, OQ, PQ Validations Work Instruction Documentation...
operating procedures. Experience with planning and executing process validations (TMV, IQ/OQ/PQ) including authoring of Master...
/Qualification activities: writing, coordinating, executing, creating reports, IQ, OQ, PQ, MVPR, etc. Experience in Risk.../qualification activities such as IQ, OQ, PQ, MVP, and Test Method Validations. Evaluate, review, and update quality records...
Validation and Verification processes, Process Validation (IQ/OQ/PQ) Documentation & Records Management: Proficient in creating...