and PQ) Participate in teams chartered with commercializing new pharmaceutical products incl. non-sterile, sterile...
development through SAT/IQ/OQ/PQ. Ensure that the procedures and systems are in place to facilitate the introduction of new...
requirement Experience writing and executing validation protocols, including IQ/OQ/PQ documentation Expertise in risk assessment...
for prototype needs, launches, and production. Validate (IQ/OQ/PQ) production processes to meet customer requirements for technical...
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports. Act...
protocols (IQ/OQ/PQ) that comply with FDA regulations Troubleshoot technical issues and lead root cause/corrective action...
. Responsible to support facilities, utilities, and equipment IQ/OQ/PQ or any other validation activity as required. Ensure...
), and validation/verification of processes and inspection methods (IQ, OQ, PQ) Develop manufacturing documentation, including work...
(IQ, OQ, PQ) – review and approve protocols and reports. Act as liaison with regulatory bodies during audits...
, and delivery. Execute validation and qualification (IQ/OQ/PQ) protocols for new products, equipment, tooling, and processes...