QA & Compliance Lead, IMP – GMP & GxP Expert

Basic Pharma; Netherlands; Remote; EUR 65,000 - 95,000; Full time

Benefits offered by this job

Internal courses

Career development

Team environment

Job summary

Basic Pharma is a Dutch pharmaceutical company seeking a QA & Compliance Officer for the IMP/ BPT area to ensure GMP-compliant production and QA processes. You will lead QMS improvements, support change controls, and supervise customer audits on site.

Requirements include at least 5 years in a quality-controlled production environment (GxP/ISO), knowledge of EU GMP and ICH guidelines, and strong English. Dutch language is a plus; HBO level education preferred.

Qualifications

• At least 5 years of experience in a quality-controlled production environment (GxP, HACCP and/or ISO).
• Knowledge of EU GMP and ICH guidelines.
• High degree of independence.
• Good knowledge of English, both spoken and written. Dutch is an advantage.
• Thorough knowledge of Windows, Word and Excel.
• Good communication skills (for colleague and customer contact).
• Diplomatic, but assertive, and a team player.

Responsibilities

• Providing QA support for the introduction of new products and processes within the IMP department.
• Registering and supporting/reviewing changes and root cause investigations in response to deviations, CAPAs, OOSs and complaints.
• Keeping track of developments within the field and in legislation and regulations and identifying bottlenecks within the IMP/BPT department.
• Implementing, maintaining and continuously improving the QMS system in accordance with these standards.
• Advising and supporting changes to protocols, procedures and work instructions.
• Providing QMS training to IMP/BPT employees.
• Independently organizing and supervising customer audits, including reporting and monitoring follow-up.
• Carrying out self-inspections.
• Monitoring progress in the handling of product and production-related quality issues.
• Guiding and performing process and product risk assessments.
• Monitoring and timely reporting of approaching deadlines for quality issues and changes.
• Supporting the review of change control documentation.
• Measuring (KPIs) and optimizing processes by setting up QA workflows with process owners.
• Supporting the QP where necessary.
• Supporting other QA processes where desired.

Skills

English proficiency

Communication skills

Independence

Team player

Problem solving

Project management

Education

HBO level education

Tools

Windows

Word

Excel

Job description

Basic Pharma is a Dutch pharmaceutical company seeking a QA & Compliance Officer for the IMP/ BPT area to ensure GMP-compliant production and QA processes. You will lead QMS improvements, support change controls, and supervise customer audits on site.

Requirements include at least 5 years in a quality-controlled production environment (GxP/ISO), knowledge of EU GMP and ICH guidelines, and strong English. Dutch language is a plus; HBO level education preferred.