The QA Engineer Specialist provides Quality Assurance oversight for GMP-regulated change-controlled projects and validation activities within a pharmaceutical manufacturing environment. The role focuses on ensuring compliance of systems, processes, documentation, and change implementations with cGMP regulations and internal quality standards. The position acts as a QA representative within multidisciplinary project teams and supports validation, qualification, CAPA management, and Data Integrity activities. The role also contributes to continuous improvement initiatives and audit readiness.
Non-Negotiable Skills, Qualifications, and Experience
- Experience working within a GMP-regulated pharmaceutical or biopharmaceutical environment
- Experience in Quality Assurance (QA) within pharmaceutical manufacturing
- Experience with Change Control processes
- Experience reviewing and approving validation protocols and reports
- Experience reviewing and approving qualification documentation
- Experience with CAPA management
- Experience participating in validation and qualification activities
- Experience performing quality impact assessments and risk assessments
- Experience with Data Integrity principles in GMP environments
- Experience reviewing GMP documentation such as change controls, validation reports, methods, or stability reports
- Knowledge of cGMP regulations and compliance requirements
- Experience working within a Quality Management System (QMS)
- Experience supporting audits or inspections
- Bachelor’s degree or higher in Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Engineering, or related field
Desirable Skills, Qualifications, and Experience
- Experience acting as QA representative in multidisciplinary or global projects
- Experience as Subject Matter Expert (SME) for Change Control processes
- Experience within manufacturing, production, or engineering-related QA environments
- Experience with continuous improvement projects
- Experience providing training or coaching within QA or GMP environments
- Experience with Master Data management or governance
- Experience with deviation management
- Experience working with cross-functional stakeholder groups
- Experience in system release activities for GMP use
- Experience in pharmaceutical engineering or technical operations environments
Practicalities
- Start Date: ASAP
- Contract Duration: 6 months
- Location: On-site
Interested in discussing this opportunity confidentially?
? m.vansloun@panda-int.com
? +31 20 204 4502