As Senior QA Specialist at our client company in Bladel, Noord-Brabant, you will maintain and continuously improve the quality system for pharmaceutical manufacturing. Handle complaints and deviations, review batch documentation, and support audits, product introductions and GMP training.
The role
At our client company in Bladel, Noord-Brabant, you will maintain, promote and continuously improve the quality management system. You will work in line with internal requirements and GMP, EU-GMP and FDA guidelines to help ensure consistent product and service quality. You will report to the QA Manager.
You will keep quality requirements up to date and manage complaints from receipt through closure and evaluation. You will also support Qualified Persons (QPs) with preparatory work. You will manage the supplier qualification system, prepare Quality Product Compliance Summaries and follow them up. In addition, you will draft new procedures and requirements and maintain existing documentation.
You will review production and packaging documentation as part of batch reviews, and handle and investigate deviations. You will represent QA in project teams working on new product introductions, change controls and improvement proposals. You will initiate GMP training, promote quality awareness across operational departments and share knowledge of EU-GMP and FDA-GMP across the site. Internal and external audits, including audits at raw-material suppliers, are also part of the role.
What you bring
- A relevant bachelor’s degree and targeted further training; a master’s degree is preferred.
- Extensive experience in a comparable pharmaceutical production environment.
- Knowledge of risk-analysis techniques and experience developing investigation protocols and reports.
- Demonstrable GMP knowledge and experience with quality systems and regulations.
- Strong communication skills and the ability to work well in a team.
- The ability to motivate colleagues and strengthen awareness of quality requirements and compliance.
- A good command of Dutch and English, both spoken and written.
What is offered
Your work contributes to animal welfare. You will work alongside well-trained colleagues in an international setting and have room for personal growth.
- Excellent employment conditions.
- A good salary.
- 30 days of annual leave for a full-time position.
- 8% holiday allowance.
- An attractive pension scheme.
- An active staff association that organizes a range of activities.
- Travel expense reimbursement.
- Training and courses.