Senior Associate QA Breda • SIRE Life Sciences

The Client 
The client is a global biotechnology company dedicated to developing innovative therapies to address serious illnesses. With a focus on advancing science and improving lives, the company works on cutting-edge research and development in areas like oncology, cardiovascular disease, and inflammation. The company is committed to delivering life-changing medicines and making a positive impact on patients' health worldwide.

The Role
The Senior Associate QA role involves ensuring quality assurance compliance in a biotech production environment, you'll support GMP activities, review production records, and maintain product quality standards across all shifts.

Responsibilities  

• Ensure adherence to Good Manufacturing Practices (GMP) in the production process.

• Review and approve batch records for compliance and accuracy.

• Provide ongoing quality support and guidance to production teams.

• Serve as the main point of contact for quality-related inquiries during production.

• Perform checks on finished products throughout production runs.

• Conduct GMP audits and ensure regulatory compliance within the production area.

• Manage and investigate deviations, initiating corrective actions when needed.

• Develop and review Standard Operating Procedures (SOPs) and Work Instructions.

• Assist in delivering GMP training to QA and production staff.

• Maintain and report on departmental performance metrics.

• MBO or Bachelor's degree in Pharmaceutical/Life Sciences or a related field, or an equivalent combination of education and experience.

• A minimum of 3 years’ experience in Quality Assurance or manufacturing, ideally within the pharmaceutical or medical device industry.

• In-depth knowledge of Good Manufacturing Practices (GMP), Good Distribution Practice (GDP), and Good Clinical Practice (GCP).

• Experience in reviewing batch records, investigating deviations, and ensuring regulatory compliance.

• Proficiency in English, both written and spoken.

• Willingness to work a 3-shift schedule, including early, late, and night shifts.

54847