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Assc MSAT Manager - Validation Expert at Roche - ApplyBlast

Assc MSAT Manager - Validation Expert

Roche

11 hours ago

4.1 on Glassdoor

Suzhou, Jiangsu, China

Onsite

Full Time

Manager

0 applicants

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About this role

The Assc MSAT Manager - Validation Expert oversees the site-level validation framework and defines technical strategies for Process, Cleaning, and Test Method Validation within a highly regulated manufacturing environment. This role serves as the core Subject Matter Expert for validation methodologies, statistical tools, and regulatory compliance, ensuring operational excellence and adherence to GMP standards. The position involves driving competence development, leading continuous improvement initiatives, and providing strategic support for manufacturing changes and technology introductions.

Responsibilities

Oversee site-level validation framework and define technical strategies for PV, CV, and TMV
Serve as core Subject Matter Expert during internal and regulatory audits
Lead root cause analyses and drive corrective and preventive actions for validation non-conformances

Skills

About Roche

roche.com

Headquarters

Basel, Basel-Stadt, Switzerland

Company Size

10001+ employees

Founded

1896

View Profile

As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.