Pharmaceutical Operations Specialist
7 days ago
We are seeking a skilled professional to join our team as a Downstream Manufacturing Engineer in our biopharmaceutical organization based in Swords. As a key member of the Integrated Process Team (IPT), you will play a critical role in ensuring the timely delivery of production schedules while maintaining alignment with site safety and quality standards.
Main Responsibilities- Material Management Oversight: Provide leadership on material management, ensuring that quality and delivery metrics are consistently met.
- Quality Investigations: Own quality investigation processes from identification to root cause analysis, driving corrective and preventive actions.
- Production Quality Metrics: Oversee daily production quality metrics, ensuring timely documentation closure, line clearance, and material management adherence.
- Continuous Improvement Projects: Drive initiatives focused on improving schedule, equipment, and delivery capabilities within the DS IPT.
- Integration and Standardization: Facilitate seamless collaboration between shift operations and day teams, promoting standardization and integration across IPT teams.
- Root Cause Analysis: Conduct RCA sessions for safety and quality-related incidents, developing and implementing corrective actions.
- MPS Standards: Promote and enforce MPS standards within the area, ensuring team alignment.
- Change Controls and Documentation: Lead/support area change controls, CAPAs, QSAT actions, and document updates as required.
- Cross-Functional Support: Provide ongoing coaching and support to cross-functional team members, sharing process and operational best practices.
- Process Centered Teams: Act as a day operations member on PCTs, collaborating with technical operations and shift operations to resolve issues and develop corrective actions.
- Bachelor's Degree in Science, Engineering, or relevant field, or equivalent experience.
- At least three years of experience in the pharmaceutical industry, preferably in drug substance manufacturing.
- Desirable experience in multiple site functions, including quality, engineering, or supply chain.
- Proven track record in change management within a GMP environment.
- Technical writing skills for GMP documentation and quality investigations.
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