Our client, a specialty pharmaceutical manufacturer, is looking for a subject matter expert in Quality to join its growing team.
Essential Duties & Responsibilities:
• Lead the Quality Assurance Team by translating Operations need and cGMP compliance into projects and daily tasks and assigning them as required to meet scheduled activities.
• Ensure cGMP Compliance in the day to day operations performed at CPI facility dealing with the manufacturing, handling, packaging, labeling, storage, and distribution of components and drug products.
• Mentor and train Quality Assurance Team members ensuring their capability to perform their functions and help them in their professional development.
• Identify resources needed to achieve assigned responsibilities and manage expenses.
• Obtain and report KPIs and identify possible improvements to ensure Safety, Compliance, and Efficiency to support Operations.
• Ensure committed timelines for projects or daily tasks are met.
• Lead cGMP Documented Processes such as: Document Standards, Change Control, Labeling creation, revision and approval, Protocol/Report review and approval. Annual Product Reviews/Reports. Internal/External Audits, Supplier Qualifications, Document Control, Batch Record issuance and review. Approval/Rejection of Components, Labels, and Finished Product, Deviation Management, Complaints Management. Review and approval of Analytical data, Stability Program, CAPA System Management, etc.
• Manage outside testing of bulk API, Excipients, Finished Product as required.
• Manage relationship with CMO in regards to quality and compliance activities.
• Lead or facilitate Root Cause Analysis Investigations.
• Support regulatory audits as needed.
• Represent the VP Quality in his/her absence.
• Additional responsibilities assigned by VP Quality.