We are seeking a Senior Associate QA to provide
quality oversight for equipment validation, packaging
qualification, and PASX master data management. This role ensures
compliance with GMP, corporate, and regulatory requirements while
supporting validation, change control, and deviation management
processes. Key
Responsibilities:
Review and
approve validation documentation for equipment, processes, and
systems.
Ensure GMP compliance for equipment
changes and provide QA guidance for technical
assessments.
Review and approve master data in
the PASX electronic batch record
system.
Conduct final QA review of technical
change controls and validate assessments from multiple
stakeholders.
Act as QA contact for deviation
records and ensure compliance with quality
standards.
Manage device and combination
product responsibilities, ensuring alignment with GMP
regulations.
Requirements
Requirements:
MBO
or Bachelor’s degree in Life Sciences, Process Technology, or
equivalent.
Minimum 3 years in the
pharmaceutical or medical device industry with a focus on equipment
and automation validation.
Strong understanding
of GMP, equipment validation, automation systems, and computer
compliance.
Logical problem-solving, risk-based
decision-making, and effective communication at multiple
organizational levels.
Fluency in English, both
written and
verbal.
Benefits
A
challenging work environment with excellent career development
programs.
Hybrid position, but at least 3 times
per week on site in Breda.
For this role, the
company offers a competitive salary
package.
Reimbursement of travel expenses is
dependable on travel distance.
The contract
will be through
Undutchables.
Application
Procedure
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