, medical devices). Strong understanding of GMP, GxP, regulatory compliance, and validation practices (IQ/OQ/PQ). Project...
and workflows Lead validation strategy and execution (URS, FDS, IQ/OQ/PQ) Drive integration with SAP, DeltaV, and PLC systems Act...
, execute, and finalize comprehensive Validation Protocols and Reports (e.g., IQ, OQ, PQ, CSV), ensuring rigorous compliance...-on experience in generating and executing comprehensive validation lifecycle documents (IQ, OQ, PQ, and potentially CSV...
, and sterility testing. Coordinate specification, procurement, installation, and qualification (IQ/OQ/PQ) of laboratory equipment...
and lifecycle management of microbiological methods, equipment qualification (IQ/OQ/PQ), and method transfers. Review and approve...
. Validation, Quality & Compliance Own and execute Process Validation (IQ/OQ/PQ) and Test Method Validation activities. Author... through pilot and commercial launch. Proven experience leading process characterisation, validation (IQ/OQ/PQ), and risk...
. Oversee validation and lifecycle management of microbiological methods, equipment qualification (IQ/OQ/PQ), and method...
development, build, test, commissioning, validation activities (IQ/OQ/PQ), RCE documentation etc. as required. Drive activities...
/OQ/PQ documentation, and change control. Ensure compliance with GMP, 21 CFR Part 11, ALCOA+, and data integrity...
introductions (NPIs), and system upgrades. Validation & Compliance: Author and execute validation protocols (IQ/OQ/PQ) and lead...