Quality Assurance Specialist, Boxmeer, Noord-Brabant

The Company
A leading global pharmaceutical and life sciences organization recognized for its strong presence in both human and animal health, with extensive expertise in manufacturing, quality operations, and strict adherence to international GMP and regulatory standards, driving innovation and excellence across the entire product lifecycle.

Role Description
As you are responsible for ensuring all production activities comply with cGMP and global regulatory standards across the entire product lifecycle, from manufacturing to distribution, you will work closely with the Qualified Person, Operational Coaches, (Senior) Operators, and the IPT Improvement team to drive quality, compliance, and continuous improvement, reporting directly to the QA-IPT Lead.

Responsibilities
- Conduct routine audits of data, procedures, systems, equipment, and facilities to ensure compliance with SOPs, GMP, and global regulations
- Review and approve production and analytical documentation for API and clinical supply batches prior to release
- Support equipment installation, qualification, and validation activities as a quality expert
- Review and approve validation and qualification protocols and reports
- Support root cause investigations for deviations and approve conclusions
- Ensure effective implementation of corrective and preventive actions (CAPAs)
- Escalate quality, safety, or compliance risks to the Qualified Person or QA specialists
- Review and approve change controls
- Review and approve master batch records and production/filling instructions
- Ensure documentation complies with GMP, internal standards, and regulatory requirements
- Perform audits and inspections independently or within a team
- Document findings, communicate observations, and support corrective actions
- Report audit results and key findings to management

Requirements
- Bachelor’s degree (HBO level), preferably in Life Sciences, Pharmacy, or a related field
- Strong knowledge of GMP and regulatory requirements
- Experience or familiarity with biological and/or pharmaceutical manufacturing processes
- Ability to support and adapt to organizational changes
- Strong analytical and problem-solving skills, particularly in root cause analysis
- Excellent communication and stakeholder management skills
- Excellent command of both Dutch and English (written and spoken)

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

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