Responsibilities: Lead the supplier qualification process by assessing manufacturing/technology capabilities. Conduct comprehensive gap assessments at target suppliers to identify areas for improvement and create individual supplier dev...
Responsibilities: CSV Deliverables and Activities for the Lab systems at the KOP Facility. Customization of Validation Plan (VP), Requirements Specification (RS), Functional Risk Assessment (FRA), Configuration Specification (CS), Instal...
Responsibilities: Performs routine production functions including filling, utility operations, packing, packaging, assembling, labeling and inspecting under general supervision. Maintains accurate records and logs in accordance with FDA ...
Responsibilities: We are seeking a Senior Quality Engineer with a strong background in IV bag or IV solutions manufacturing to join our healthcare manufacturing team. The ideal candidate will have experience in a regulated manufacturing e...
engineering, Life Sciences, or a related field. 5+ years of experience as a Validation Engineer in the pharmaceutical...
Responsibilities: leading/coordinating execution of (CMC) regulatory filing strategy and managing or supporting regulatory processes to achieve timely approval. preparing high quality CMC regulatory documents or packages in accordance w...
Roles & Responsibilities: Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Mentor QA personnel, including organizing and prioritizing daily tasks, and performing t...
Responsibilities: Strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions. The ability to lead and/or support multiple projects simultan...
. Bachelor's degree in Biological Sciences with 3+ years Regulatory Affairs experience OR Master's degree in Regulatory...
Responsibilities: Writes and executes commissioning, qualification, & validation protocols for facilities utilities, equipment, and computerized systems. Writes final reports. Resolves protocol discrepancies and deviations. Reviews ...