Quality Engineer at Datwyler ensuring compliance with regulatory requirements and supporting manufacturing processes. Collaborating to drive continuous improvement initiatives in a regulated environment.
About the role
- Quality Assurance Manager ensuring compliance with GMP and regulatory standards for pharmaceutical products. Overseeing QA activities and maintaining a strong quality culture at the site.
Responsibilities
- Supports and strengthens the site’s Quality function by ensuring compliance with GMP, regulatory requirements, internal quality standards, and customer expectations
- Oversees day-to-day Quality Assurance (QA) activities depending on the organization’s structure
- Drives continuous improvement, maintains a strong quality culture, and ensures the consistent manufacture of safe, effective pharmaceutical products
- Leads Regulatory and External Customer Audits including preparation, execution and follow-up
- Maintains and continuously improves the site’s Quality Management System (QMS) in alignment with ISO 9001, ISO 15378, and other applicable regulations
- Ensures timely and compliant batch record review and product release processes
- Manages and develops QA staff, providing coaching, training, and performance evaluations.
Requirements
- Bachelor’s Degree required
- Science or engineering-related field a plus
- 5-7 years of relevant work experience, in a Q Manager/Engineer role
- Thorough knowledge of cGMP regulations and current industry practice
- Knowledge of ISO 9001 and ISO 15378
- Good knowledge of domain-specific legislation, standards rules and procedures
- Fluent in English, both verbal and written
- International travel propensity required
- Experience in customer-facing role desirable
Benefits
- Diversity and a wide range of career opportunities
- Interesting development opportunities with training and assignments in a global environment
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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