Compliance Specialist (Audit)

Primary Function:

• To conduct internal and external audits and maintain the audits schedule.
• Responsible for compliance activities in the plant.
• Responsible for managing the supplier quality program.
• Responsible for SAP & POMS changes and verification of recipes, inspection plans, etc.
• To ensure all complaints are properly investigated per Abbott's requirements and responded to affiliates in a timely manner.
• Works with cross-functional teams to identify causes, track progress, and drive resolution of quality issues.
• To ensure metrics for complaints are collated and trended.
• Responsible for the QA-related activities for new product introduction.
• Knowledge of basic principles, methods, technologies, and practices of a professional/technical field.
• General knowledge of procedures and activities within own work area.
• Focused on learning the key aspects and duties of the job being performed.
• Applied research, information gathering, and analytical skills.
• Handle detailed, structured problems.
• Works on assignments where judgment is required a majority of the time.
• Works under general direction, seeking assistance as needed.
• Contributes to own team/closely related teams through quality and accuracy of own output.
• Conveys information in a concise and professional manner.
• Asks effective questions and solicits feedback to understand needs.
• Anticipates future needs based on past transactions.
• Ensure product registration is completed in a timely and accurate manner.
• Any other duty as assigned by supervisor.

Major Responsibilities:

• Ensure all quality systems are in compliance with Abbott's corporate and division policy, procedures, applicable regulatory standards.
• Responsible for document control and certifications (product quality related).
• Applies advanced knowledge of technical/administrative skills to leverage the skills of others, ensuring all document change packages are processed timely and accurately.
• Conduct internal and external audits and maintain the audits schedule. Responsible for compliance activities in the plant.
• Responsible for SAP changes and verification of recipes, inspection plans, etc.
• Develop an understanding of internal operations and how related teams interact to achieve results.
• Work is guided by operational and project objectives. Improves process efficiencies in support of objectives. Uses a variety of data analysis tools and methodologies. Applies independent judgment to solve systemic problems.
• Recommends actions and regularly exercises discretion with regards to key business processes within the team.
• Plans and oversees the daily activities of a team.

Requirements:

• Bachelor's Degree in Engineering/Science or related disciplines.
• Minimum 1-3 years of relevant experience in quality control/quality audit in pharmaceutical/food manufacturing preferred.
• Good leadership and problem-solving skills. Good communication and report writing skills.
• Project management skills or experience in project management is essential.
• Team player with initiative, drive, good communication skills, and a strong command of written English.
• Proven problem-solving capability, customer focus, and commitment to continuous improvement. Knowledge of HACCP and ISO systems preferred.
• Working exposure and understanding of manufacturing processes.
• Knowledge in food engineering, thermal heat processing, and fluid flow characterization, as well as experience in the dairy/nutritional industry, would be advantageous.

• Kindly note that this position is based in Tuas.