Publikováno v: Ostatní v Chicago | Nejnovější změněné: |
Job Description
Key Responsibilities
Responsible for creation, planning & approval of validation documents to support validation requirements.
Responsible for participating in implementation & maintenance of effectiveness of the Quality system to meet applicable regulatory requirements.
Adhere to Good Manufacturing Practices (GMPs), ISO:13485, ISO:14971, & 21 CFR 820.
Ensure that practices & procedures comply with company policies & applicable regulations for the Quality areas.
Execute tasks as required to implement Validation Master Plan & maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing process to demonstrate that products will perform consistently as intended.
Supervise contract validation resources in the timely completion of activities in his/her area of responsibility.
Represent department in quality audits, both internal and external, regarding validation & engineering compliance.
Perform Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ).
Participate in implementation & maintenance of effectiveness of Quality System to meet all applicable regulatory requirements.
Ensure that all practices & procedures comply with company policies & applicable regulations for the Quality areas.
Document control of nonconforming products & implementation of corrective & preventative actions (CAPA) to address identified root causes compliant with ISO:13485 standards & 21 CFR 820.90.
Execute process monitoring plans based on quantifiable production & quality metrics.
Participate with plant & external engineering resources on new installations & systems to ensure that factory, site, & commissioning documentation is in accordance with current Good Manufacturing Practices (“cGMP”) & supports validation.