Purpose Statement: 

• Ensures appropriate policies and standards are applied and that engineering activities have robust quality oversight.
• Responsible for adhering to Validation Plans for Process Equipment, Facility and Utility, Lab equipment and Shipping Validation for initial and periodic evaluation.
• Coordinate validation activities actively, ensure flawless execution of protocols and procedures
• Support on topics related to Qualification during inspections and audits
• Responsible to analyze trends, identify and resolve issues that potentially impact validated status of E/F/U systems.

Responsibilities: 

• Adhere to Validation plan and procedure related to E/F/U systems Qualification, Lab equipment Qualification and shipping Validation.
• Adhere to continually evolving GMP regulations and industry practices with particular relevance to qualification of E/F/U systems, lab equipment and shipping validation and contribute to the implementation of plans to address any gaps
• Adhere to appropriate validation master plans and validation execution plans related to E/F/U system, Lab equipment and Shipping validation in the AbbVie Operations Campus in Tuas, Singapore comprising of both API and Biologics manufacturing facilities.
• Generate and execute protocols for initial and subsequent re-qualification programs related to E/F/U systems, Lab system and Shipping validation.
• Work with cross functional team in providing Quality oversight in E/F/U and lab equipment
• Qualification related procedure and ensure compliance to GMP standards and AbbVie policies and procedures
• Actively engaged in developing specifications for E/F/U systems and assist in Commissioning (FAT / SAT etc., not limited) of related system as part of the new build-outs
• Collaborate with other AbbVie sites within the network to ensure a harmonized approach to Qualification.
• Act as one of the key focal points for Qualification and Validation (E/F/U, Lab equipment & Shipping validation) topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert, front regulatory audits, when needed.