Our client is a global biotechnology leader dedicated to advancing innovative therapies that improve patient outcomes worldwide. With decades of scientific excellence, the organization focuses on developing cutting‑edge biologics and breakthrough medicines supported by state‑of‑the‑art manufacturing facilities. The company fosters a culture rooted in quality, integrity, and continuous improvement, driving meaningful impact in healthcare across multiple therapeutic areas.
Role DescriptionAs a QA Operations Specialist, you will play a key role in ensuring high standards of quality and compliance across equipment, automation systems, and validation activities within a GMP‑regulated environment. You will oversee validation processes, support engineering and operations teams, and contribute to quality investigations and risk management activities. In this role, you will act as a subject‑matter expert, ensuring all systems, processes, and documentation meet regulatory, corporate, and industry requirements. This position requires strong analytical capabilities, a structured mindset, and the ability to collaborate across multiple technical disciplines.
Responsibilities- Provide QA oversight for validation of equipment, automation, and information systems.
- Review and approve validation documents, ensuring alignment with site, corporate, and regulatory expectations.
- Support the development of validation strategies in collaboration with cross‑functional teams.
- Review and approve equipment modifications, parameter updates, and like‑for‑like assessments.
- Approve updates to maintenance procedures, including preventive and corrective activities.
- Manage responsibilities related to device and combination product quality, ensuring alignment with GMP and global quality standards.
- Represent QA in QRM processes such as pFMEA, QRAES, and computer system compliance assessments.
- Ensure site risk management activities align with corporate policies and regulatory expectations.
- Review and endorse quality risk assessment reports.
- Conduct final QA reviews of technical change controls, validating completeness and accuracy.
- Act as QA SME, gathering insights across QA functions to deliver risk‑based, compliant assessments.
- Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or related field.
- 5–8 years of experience in a GMP‑regulated environment.
- Strong background in equipment and automation validation.
- Solid understanding of GMP regulations, computer system compliance (Annex 11, Part 11), and validation best practices.
- Experience with risk management tools such as FMEA.
- Knowledge of statistical tools for sampling strategies and hypothesis testing.
Looking for a new career challenge? This opportunity may be the next step in your professional growth.
If you’re interested, please click the button below to apply.
#J-18808-Ljbffr€50000 - €75000 monthly