Senior Manufacturing Specialist

About the role

AbbVie is hiring a Senior Manufacturing Specialist in Singapore. The role ensures operational efficiency and compliance by managing technical documentation, addressing non-conformances and implementing corrective actions, while streamlining processes and driving continuous improvement across manufacturing operations.

Key responsibilities

• Write technical documents and investigate non-conformance issues with Operations and cross-functional teams
• Develop and implement corrective and preventive measures, manage change processes and prepare training modules for Operations and new employees
• Analyse key performance indicators and optimise workflows
• Author and revise GMP-related documents and electronic batch records
• Lead or take part in projects improving operations or introducing new products
• Use quality management and operations software such as Trackwise, LIMS, SAP, POMSnet or Delta-V
• Support regulatory inspections and internal audits, and act as the point of contact for change management documentation during audits and inspections
• Carry out regular GEMBA walkdowns, hold cross-functional meetings and ensure investigations and process improvements are completed on time
• Adhere to EHS policies and ensure investigations are thorough and accurate

Required profile

• Master's degree or equivalent with at least 5-7 years of relevant experience in a biologics production facility
• Experience with cGMP documentation and record maintenance
• Experience with regulatory inspections is required
• Strong ability to lead cross-functional teams, good presentation and technical writing skills

Required skills

• Good working knowledge of cGMP and manufacturing regulatory requirements (preferred)
• Strong working knowledge of GMP systems such as Trackwise, SAP, LIMS and MES (preferred)