QA 31436

Location: Leiden Salary: competitive
Sector: Pharma & Biotech Type: Contract

Job Title: (Senior) QA Associate
Main purpose:
The Senior QA Associate provides support for special quality projects and is the process owner for
several quality processes. Performs in various quality functional areas and maintains expertise.
He/she enforces quality requirements, establishes quality systems for new technologies, reviews
development data, approves quality documentation and supports activities related to regulatory
submissions and inspections. Uses intrinsic quality to interact with stakeholders and support the
site's overall quality level.

Key responsibilities:
* Serves as a dedicated quality representative on project teams responsible for design and
development of drug products.
* Preferably lead auditor for GMP manufacturing for sterile manufacturing and fill finish activities.
* Serves as the primary quality assurance contact for internal and external business partners and
* Responsible for QA review of vaccines drug substance manufacturing and qualification and
validation projects
* Focuses on technical issues relative to interpretation of policies, compliance and current
industry standard.
* Serves a project leadership role as well as assists or participates in special quality projects like
the implementation of Intrinsic Quality.
* Maintains and interprets KPI's and takes measures to improve.
* Effective stake holder management. Contact person for production, analytical and technical
global quality initiatives.
* Challenges the status-quo. Involved in conception of new ideas with respect to production,
analytical and technical quality processes.
Specific professional/technical requirements:

Education: Minimally MSc in a relevant discipline, like biomedical sciences, (medical) biology or life
Languages: English, Dutch is recommended
Experience: Requires (6-8) years QA experience, content knowledge, can be a QP
Pro-active, agile, and enjoys working in a team. Good organizational and communication skills,
creativity, problem-solving capabilities and a process-thinking mindset are key for this position.