Senior Compliance Specialist – Quality Assurance

2 weeks ago

Singapur, Singapore Lonza Full time

Senior Compliance Specialist – Quality Assurance Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. As a Senior QA Specialist, you will support day‑to‑day Quality Assurance activities in accordance with approved SOPs / Policies for a multi‑product, cGxP contract manufacturing facility in Quality Compliance (External). Key Responsibilities Highly motivated and possess superior skills relevant to the role. Member of cross‑functional site teams on projects/issues. Lead complex deviation investigations, change controls and CAPA proposals. Superior ability to troubleshoot. Reviewer and approver of SOPs or records. Coordinate between departments for multiple parallel activities. Understand advanced topics pertaining to cGMP. Participate in Customer / Agency Audits and Inspections as required. Identify process pathways and develop improvements in strategy. Assist in leadership of other process areas. Assume supervisory responsibility in the absence of a supervisor. Understand and articulate company business strategy; maintain a broad view of business to recognize changes and trends. Uphold data integrity principles in accordance with Lonza policies; proactively evaluate, identify and improve data integrity processes. Perform material release and qualification; conduct joint inspections to identify material defects and review vendor’s investigation reports as required. Coordinate to deliver Supplier Quality Agreements in a timely manner. Own documents of the assigned quality processes when applicable. Develop skills to become a qualified trainer in the area of expertise. Act as a subject‑matter expert in one or more areas. Perform any other tasks as and when assigned by a supervisor. Key Requirements Degree in Engineering/Science or higher from a recognized institution with 5 to 10 years’ experience in quality in the biopharmaceutical industry. Familiarity with regulatory requirements and local codes & standards (e.g., FDA, EMEA, ICH Q7). Good knowledge and experience of the practical and theoretical requirements of a quality management system in a GMP facility. Good interpersonal skills. Effective communicator (oral and written). Evidence of good quality decision‑making traits. Meticulous, systematic, and analytical mind. Team player who can operate independently, with a strong focus on safety, quality, and timelines. #J-18808-Ljbffr

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