Director, Quality Assurance - GxP (GCP) Remote
Axsome Therapeutics IncFull Time
Senior (5 to 8 years)
Candidates must be residents eligible to work full-time in the UK or Ireland, possess a degree or BTEC (or equivalent) in a pharmaceutical or science-related subject, and have a minimum English proficiency equivalent to RQF Grade 2, EQF Grade 3, or SCQF Grade 5. A minimum of 2 years of experience in a GMP environment is required, with a preference for experience in Quality Assurance Production, Validation, Microbiology, or Aseptic Manufacture of medicinal products. Strong working knowledge of Microsoft Office programs, including Excel, and experience with TrackWise software are preferred.
The Quality Assurance Associate will support the continuous compliance of the Compounding Unit with cGMP and "Specials" manufacturing requirements, local procedures, and Baxter Corporate policies. They will assist in the release of manufactured products, perform in-process checks, and record any errors according to defined procedures. This role involves checking facility status, equipment, product, and manufacturing documentation, as well as supervising compounding processes from picking to release. The associate will escalate and resolve product quality issues, ensure GMP adherence, investigate product and service complaints, and implement corrective and preventative actions. They will also manage environmental monitoring schedules, conduct real-time risk assessments and GEMBA walks, and facilitate continuous improvement opportunities. Responsibilities include reviewing and approving controlled system work orders, raising and investigating non-conformance reports, supporting production process reviews, and assisting with qualification, maintenance, and calibration activities. Additionally, the associate will identify and escalate supplier issues and support investigations through SCARs or B2B processes.
Provides essential medical products and services
Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.