Senior Design AssuranceEngineer

West Pharmaceutical Services Singapore Pte Ltd; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Singapore seeks a Senior Quality Engineering Specialist to ensure proprietary design and development projects meet compliance standards. The role involves guiding teams on design quality issues, managing quality aspects, and driving compliance and continuous improvement within the company. Candidates should have a degree in Chemistry, Engineering, or Quality discipline, with 5 to 7 years' experience in regulated manufacturing as well as knowledge of ISO standards.

Qualifications

• 5 to 7 years working in a high-volume regulated manufacturing environment.
• Practical experience working with design teams according to regulatory requirements.
• Risk Management experience within design and development.

Responsibilities

• Ensure compliance with relevant regulations and internal procedures.
• Identify and support improved quality practices during design control activities.
• Review and approve design history file documents and product specifications.

Skills

Design assurance support

ISO 13485

Project Management

Risk Management

Analytical tools

Education

Degree in Chemistry, Engineering or Quality discipline

Tools

Minitab

Job description

Reporting to the Design & Quality Assurance Director, the job holder will be the QA lead supporting West proprietary design & development projects (in Elastomer & Primary Containment) with key focus and responsibility around the interpretation, application of and compliance to relevant standards, regulations and internal procedures. The Senior Quality Engineering Specialist will manage the quality aspects of West proprietary design & development projects; will provide West proprietary design & development teams with guidance on design quality-related issues and design control best practices; and drive a culture of compliance and continuous improvement within West proprietary design & development teams.

Essential Duties and Responsibilities:

• Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.
• Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
• Report on the progress of projects; identify successes; and drive compliance.
• Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.
• Review and approve relevant design history file documents; product drawings; component specifications; labelling; procedures.
• Support design transfer activities for commercial and launch readiness and sustainment.
• Review and approve test method validations (protocols and reports).
• Review and approve design verification and design / process validation documents (e.g. protocols & technical reports).
• Facilitate and support the completion of projects up to and including PQ.
• Responsible for reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects.
• Facilitate and/or participate in risk assessment meetings with proprietary design & development teams.

Education and Experience:

• Degree in Chemistry, Engineering or Quality discipline
• 5 to 7 years working in a high-volume regulated manufacturing environment.
• Desirable: Regulatory Affairs experience

Preferred Knowledge, Skills, and Abilities:

• Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
• Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
• Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
• Experience in Project Management
• Experience in process technology, by preference with elastomers.
• Risk Management experience within design and development with good working knowledge of ISO 14971.
• An excellent understanding of rubber and plastic manufacturing technologies, analytical methods and testing.
• Knowledge of analytical tools and methods, including statistics (Minitab preferred).
• Support and contribute to Lean Sigma programs and activities.
• According to the principles of health and safety at work (substantiated by the Safety Leadership Statement), the job holder is aware of his/her particular responsibility regarding work safety and acts accordingly at all times
• Able to comply with the company’s quality policy at all times.
• The job holder is aware of his/her special responsibility for quality according to the company’s quality policy and conducts his/her activities in accordance with the company quality policy at all times.
• The job holder respects all responsibilities arising from cGMP requirements and from ISO 13485, ISO 9001, ISO 15378, ISO 14971 and 21 CFR Part 820, as per the current versions and to any future amendments.

Travel Requirements:

Must be able to travel up 5%