The Company
The company is a global biotechnology company dedicated to improving the lives of patients. In Breda they focus on preparing, planning, and coordinating the shipping and distribution of clinical trial materials.
Role Description
The Specialist QA - Validation ensures compliance with corporate, site, and regulatory standards by providing quality assurance oversight for equipment, automation, and information systems validation. This role acts as a key partner to operations, offering guidance on quality policies and supporting investigations and testing strategies. The position requires strong expertise in GMP compliance and quality engineering principles to maintain high standards across processes and systems.
Responsibilities
- Defining strategies and reviewing documentation for process, equipment, and IS validation in collaboration with relevant departments, ensuring GMP compliance.
- Approving equipment changes, parameter adjustments, and updates to maintenance procedures, including preventive and corrective actions.
- Managing device-related responsibilities and ensuring adherence to GMP regulations.
- Representing QA in risk assessments (e.g., pFMEA, QRAES) and ensuring site activities align with corporate policies.
- Performing final QA reviews of technical changes, consolidating input from stakeholders, and confirming completeness of records.
- Providing expertise for testing strategies and investigations, applying risk-based approaches.
Requirements
- Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or equivalent; 5–8 years in a GMP environment.
- Proven experience in equipment and automation validation, computer system compliance (Annex 11, Part 11), and risk management tools (e.g., FMEA).
- Ability to interpret complex situations using multiple data sources; proficiency with statistical tools for sampling and hypothesis testing.
- Strong attention to detail, effective communication across levels, decision-making using risk-based approaches, and collaborative teamwork.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.