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Quality & Compliance Engineer

Posted on Nov. 27, 2024 by NO DEVIATION PTE. LTD.

Singapore, Singapore
N/A

Full Time

No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.

We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.

The Quality & Compliance Engineer position is within the Engineering Compliance & Support team, which is vital in assisting the Facilities & Engineering department to maintain quality and compliance across its operations and business processes. The candidate will help promote a culture of Continuous Improvement within the department. Reporting to the Senior Manager of Engineering Compliance & Support, this role will serve as the primary contact for Operational Excellence, training, continuous improvement initiatives, and the Engineering Innovation strategy within the Facilities & Engineering department.

Key Responsibilities:

Drive the implementation of Operational Excellence and Continuous Improvement initiatives, focusing on measuring labor productivity, identifying opportunities for enhancement, and establishing relevant metrics and measurement systems
Support Change Management efforts for key functional initiatives and Lean Transformation certification
Oversee the maintenance of visual boards and measurement systems for effective daily management
Manage departmental Business Performance metrics, providing regular reports and escalating issues as needed to senior leadership.
Develop and manage risk mitigation strategies, Business Continuity Plans, and disaster recovery modules, including conducting risk management assessments and business impact analysis
Identify and provide educational opportunities to the department on how digital solutions may impact team workflows, while supporting the integration of these changes
Assess and review the department’s current digital capabilities and expertise levels
Collaborate closely with departmental stakeholders to develop a digitalization strategy and key initiatives
Work with stakeholders to understand operational processes, pinpoint inefficiencies, and partner in driving digital transformation efforts
Define and implement digital initiatives to deliver the desired business outcomes
Coordinate effectively within the project team and maintain strong collaboration with external functions
Manage daily project activities and resources, while leading project management team meetings
Continuously monitor project progress and provide regular status updates to key stakeholders
Assist the department in preparing for site Inspection Readiness meetings and serve as the auditee for ASM internal audits
Participate as a member of the F&E Triage team for all regulatory inspections, managing inspection requests, preparing responses, and advising Subject Matter Experts on response strategies
Support inspection readiness and conduct pre-audit walkdowns to ensure F&E complies with required standards
Track and support F&E Quality Management Review metrics, ensuring appropriate visual boards are maintained
Lead deviation investigations for F&E with the collaboration of Functional Area Owners and other SMEs, and provide support for F&E deviation triages

Requirements:

Master’s degree in Computer Science, Engineering, or a related field
Bachelor’s degree with 2 years of directly related experience in a pharmaceutical manufacturing environment
Associate degree with 6 years of directly related experience in a pharmaceutical manufacturing environment
Familiarity with documentation in highly regulated settings
Ability to work both independently and collaboratively
Strong understanding of customer needs and quality requirements
Excellent team player, capable of working effectively within and across teams
Good planning and tracking skills, with the ability to use appropriate program management tools and manage multiple programs based on priorities
Highly organized with the ability to manage timelines, deliverables, and resources effectively
Strong interpersonal, verbal, and written communication skills, with the ability to simplify complex information
Skilled in prioritizing and multitasking to enhance productivity and manage workload in a fast-paced, rapidly changing environment
Demonstrates critical and creative thinking, problem-solving abilities, and clear, concise written and verbal communication
Customer-oriented with a strong focus on meeting customer needs
Knowledge and experience in operational excellence and project management
Ability to tactfully negotiate and positively influence peers, with added advantages for knowledge and experience in digitalization