Posted on Apr 24, 2021 by Elevate Direct
Drug Product Lyophilization Specialist - Vaccines
Location: Louth, Ireland
Involvement in the manufacturing process design, construction of facility, co-leading C&Q, support on PQ, site operation, PEV, calibration activities.
Be responsible for the lyophilization production activities.
Plan and organize GMP/EHS training for group members.
Assign works to each member to fulfil the needs of production and equipment management.
Follow-up training and the qualities of operator, complete required skill trainings for each individual according to set training module.
Coordination and onsite support on preventative maintenance and repairing.
Coordination and onsite support on instrument
Participate in checking and arranging the document.
Be responsible for the management and assisting in the cleaning and maintenance including equipment in the area.
Be responsible for recovery and distribution.
Be responsible for executing 5S in the area.
Support validation in the area.
Participate in drafting and revising the document meeting cGMP.
Coordination and onsite support on instrument calibration.
Maintenance on equipment status labeling.
Be responsible for the shipping and locating of facilities and equipment in the area.
Introduction new facilities.
Change control compiling and implementation.
Department fixed assets management.
Prompt repair machine breakdown.
Continuously improve the performance department facilities.
Ensure data integrity of all facilities.
Degree or above, major in biology, pharmacy, chemistry or engineering,
In depth technical knowledge and experience in biopharmaceutical development, GMP manufacturing, and quality assurance and control.
At least 10 years experiences in Vaccine, Biotech or pharmaceutical industry.
Demonstrated excellent management skills and leadership.
Global perspective, Strategic thinking, Strong leadership.
Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
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