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The Position

The Opportunity:

The Compliance Engineer (Senior) / Compliance Engineer (Associate Principal) will play a leading role as change agent in supporting the site towards the zero defects goal. The team will focus on discrepancy management, trending, and proactive continuous improvement across the organization representing all functions. The position requires proficiency in conceptual, analytical thinking toward identifying root cause, teamwork, collaboration to identify and implement solutions, and technical writing capabilities to write clear and concise quality records. The position will provide skill and professional development in Technical Writing, Quality Systems, RCA Methodologies, Risk Management, Continuous Improvement Methodologies, Project Management, and presenting to Health Authorities and Compliance Audits.

As the Compliance Engineer (Senior) / Compliance Engineer (Associate Principal), you will be responsible for:

Drive end-to-end (E2E) ownership of deviations and continuous improvement (CI) for the site.
Assure robust root cause analysis (RCA) is performed and continuously improved
Apply CI strategies to proactively identify/ follow through initiatives to prevent deviations and improve the overall effectiveness of deviation management at RSTO.
Support cGMP compliance and inspection readiness for areas of accountability at all times.
Support preparation, execution, and follow-up of inspections (audit responses), audits, and self-inspections for areas of accountability and site.
Establish, sustain, and leverage effective partnerships with network counterparts to share best practices and influence the design and implementation of our network compliance policies, standards, and processes.

Who You Are:

At least a degree in a relevant science/engineering discipline with at least 8-10 years of relevant experience in the pharmaceutical industry. Experience with mammalian/bacterial biopharmaceutical production is strongly preferred.
Exhibits good knowledge of international cGMP and compliance requirements. Proficiency of the technical process and workflow of deviation management.
Display a good level of problem solving ability and provide suggestion/alternative solutions on complex issues resolution.
Displays strong interpersonal, exceptional teamwork and collaboration skills.
Ability to communicate clearly and professionally in both writing and verbally.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

Roche Singapore Technical Operations, Pte.

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Compliance Engineer (Senior) / Compliance Engineer (Associate Principal)