We are seeking a Senior Manager QA Media Operations
- Directs staff of QA media operations specialists that review and approve device master records, batch records, testing, and aseptic operations. Oversees batch release. Develops and plans strategy and departmental goals, establishes timelines and monitors progress and completion.
- Provides oversight of aseptic operations including managing QA on the floor team to observe aseptic processing, including media fills to meet US and international aseptic processing requirements (FDA Sterile Product Aseptic Processing Guidance and Eudralex, Annex 1,”Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820). Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations, and participates in the development of action plans to correct deficiencies and improve quality processes.
- Provides direction for complex deviations and complaint investigations; Managing media deviations, CAPAs and Complaint handling and ensuring that quality related deviations, complaints are escalated, investigated and resolved.
- Leads or supports regulatory or client audits as Aseptic Media subject matter expert.
- Develops and approves cGMP documents including, but not limited to, SOPs, batch records and specifications. Ensures process is efficient.
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
- Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.