Manufacturing Specialist - Singapore - ABBVIE

ABBVIE

Verified Company

Singapore

1 week ago

Posted by:

Wei Jie

beBee Recruiter

Description

Purpose Statement

To perform investigations, change plans or other functional support associated with cGMP manufacturing operations within the biologics production facility and work cross functionality.

Major Responsibilities:

Perform technical writing and investigation of nonconformances in collaboration with Operations including material defects
Identify and put in place appropriate corrective and preventative actions in collaboration with Operations team
Owner of change plans in collaboration with cross functional teams, including global cross functional team, if required
Work with Quality systems (e.g. CAPA and change plans) and Operations Related System (LIMS, SAP, PI, Maximo, MS Office)
Participates in continuous improvement projects for operations
Trends Key Performance Indicators and implement measures to streamline work processes and procedures
Assist in regulatory inspections
Works under close supervision

For more experience individual, you are required to:

Supports new product introduction projects and leads continuous improvement projects for operations
Support in regulatory inspections, detailing investigations and change plans
Structure training program for new hires and conduct relevant trainings
Works with mínimal supervision
Bachelor in Science or Bachelor in Engineering with at least 2 years of relevant experience
Experience with cGMP documentation and record maintenance
Strong working knowledge of GMP systems (e.g. Trackwise, SAP, LIMS, MES systems)
Knowledge and experience in root cause analysis and investigation
Strong critical thinking, problem solving and technical writing skills
Ability to lead crossfunctional team discussions
Excellent attitude towards work, with strong workload management and to drive tasks to completion
Experience with regulatory inspections is required
Good interpersonal and communication skills