Job Post Information* : Posted Date
1 week ago(7/11/2018 6:27 PM)
# of Openings
PRIMARY PURPOSE OF POSITION
In this role, you will support the Quality Assurance organization at Dynavax Düsseldorf manufacturing facility. This role requires the successful candidate to:
MAJOR DUTIES OF POSITION
To support or contribute the preparation, review, and approval of qualification and validation related documents
To ensure that appropriate quality standards are applied in accordance with regulatory, corporate and industry requirements.
To assist in and drive quality-related activities including the preparation, review, and approval of cGMP documentation.
To perform or assist in general organizational tasks including oversight and escalation of open tasks and timelines, tracking of tasks, generation of technical reports, and reporting of quality metrics.
To participate in meetings to report on, contribute to, and / or resolve quality-related matters and represent QA in various internal and external meetings to provide QA - related expertise
KNOWLEDGE AND SKILL REQUIREMENTS
Bachelor’s degree or higher in Biology, Chemistry, Engineering, Industrial Management, Operations, Quality, or Manufacturing (other degrees in combination with relevant experience acceptable) or equivalent experience in pharmaceutical industry.
5+ years of relevant work experience in Quality Assurance or in combination with relevant education.
Experience in qualification and/or validation practices
Experience in Quality Assurance for Validation
Working knowledge of current federal, local, and international regulations regarding the production, testing, and release of drug substances and drug products
Good understanding of cGMPs, industry and regulatory standards and guidelines
Excellent interpersonal skills
Experience working with cross-functional teams
Strong ethical foundation and a sound compliance understanding
Mandatory business fluent in English, German fluent preferred