BioPharma Senior Manufacturing Analyst
AbbVie
- Westport, Co Mayo
- Permanent
- Full-time
- Plan and schedule activities for Manufacturing Technicians, ensuring that all aspects of the area are fully staffed and that any constraints are managed appropriately or escalated to the TSL.
- Schedule activities in a multi-product facility, switching between product campaigns seamlessly
- Ensure all activities are completed in line with regulatory (QA & EHS) and corporate requirements
- Triage and troubleshoot equipment issues as they arise, escalate to maintenance
- Actively lead and/or participate in Root Cause Analysis of non-conformances, equipment issues, environmental monitoring out-of-limits and complaints as they arise. Engage other Departments to resolve issues as required.
- Using skills matrix for Operations Team, drive cross-training to ensure performance of team and individuals
- Lead and support continuous improvement initiatives as required to support the overall goals of Core 1
- Promote and develop a culture of Right First Time
- Provide leadership at Tier meetings to ensure focus is maintained on key objectives for the shift
- Compile metrics as required for Perfect Index and others
- Review and contribute to technical documents, including protocols, reports and batch manufacturing documents
- Other duties as assigned
- Bachelor's degree in a related scientific field is required; and/or a minimum of 4 years' experience in aseptic manufacturing environment. Must have experience in aseptic techniques, formulation, aseptic filling of sterile product and/or visual inspection of Parenteral products.
- Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.
- Comprehensive understanding of contamination control principles
- Possess strong technical knowledge and application of concepts, practices, and procedures.
- Good interpersonal skills to develop working relationships with people at all levels
- Previous people management experience is desirable