Quality Assurance Specialist – GMP Manufacturing, Breda, Noord-Brabant

Company
A leading organization in the pharmaceutical manufacturing sector, committed to producing high-quality, safe medicinal products in a regulated environment. They prioritize continuous improvement, technological innovation, and a collaborative team culture to serve patients effectively.

Job Description
We are seeking a proactive and detail-oriented Quality Assurance Specialist to join the Plant QA team. This role involves providing essential quality oversight during packaging and labeling operations, supporting compliance initiatives, and ensuring documentation accuracy to meet GMP standards.

Responsibilities
- Conduct final quality checks on labeling and packaging processes before product release.
- Review batch records to verify data accuracy, completeness, and compliance with procedures.
- Handle quality issues by investigating deviations, documenting findings, and following up on corrective actions.
- Collaborate closely with Production, Maintenance, and QA colleagues, providing guidance and escalation when necessary to halt production if quality concerns arise.
- Maintain clear deviation documentation and support corrective and preventive actions.
- Participate in ongoing GMP compliance activities, including GMP training, incident investigations, and quality improvement projects.
- Review and approve operational SOPs and work instructions as needed.
- Prepare and analyze weekly and monthly QA metrics and maintain departmental performance boards.
- Act as a key point of contact for production-related quality queries and support cross-departmental cooperation.

Requirements
- MBO or BSc degree in Pharmaceutical, Life Sciences, or a related field, or equivalent experience.
- Approximately 3 years of QA or manufacturing experience within the pharmaceutical or medical device sectors, with a focus on batch record review and investigations.
- Strong knowledge of GMP, GDP, and/or GCP regulations, and experience applying them in routine activities.
- Excellent attention to detail and technical knowledge in manufacturing and quality processes.
- Fluent in English, with good communication and collaboration skills.
- Resilience under pressure and assertiveness to address quality concerns confidently.

Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.

This role involves working on a 3-shift schedule: early, late, and night shifts, with a fixed schedule for each week. 

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