QA Supervisor

Job Description

1906 QA Supervisor

Education

• A Bachelor's degree in engineering, chemistry or other science is required. A Master's degree is preferred.

Experience

• A minimum of 6-10 years of Pharmaceutical/GMP experience
• At least 1 year in a supervision role is required.
• Excellent knowledge of manufacturing operations in a liquid solid dosage manufacturing facility.
• Provides support as needed during regulatory inspections, audits and regulatory filings related to manufacturing and product release activities; develops and monitors appropriate CAPA plans. Responsible to ensure timely and adequate responses to any audit/inspection observations relative to QA Operations; ensure corrective action is implemented and evaluated for effectiveness.
• Selects, develops, and motivates and retains qualified Quality operation staff to effectively carry out Quality Operation functions within their area of responsibility, and provide for the continuity of managerial and specialized skills.
• Assures compliance to U.S. GMPs (21 CFR 210/211) regulations. Maintains the Quality Operations area in an inspection ready state.
• Assesses compliance level of direct reports and overall operation through auditing internally, walk through and triage manufacturing / engineering events.
• Proactively ensures relevant SOPs reflect current practices and follow FDA and other regulatory requirements and guidance.