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Join a cutting-edge pharmaceutical team where your precision and passion for quality will help shape the future of life-saving medicines! Proclinical is seeking a Quality Assurance Associate specializing in Qualification and Validation to join a dynamic quality team. In this role, you will play a key part in ensuring equipment, systems, processes, and facilities meet regulatory standards and internal quality requirements. This position focuses on validation activities, documentation, and collaboration with cross-functional teams to maintain product quality and compliance.
Job Responsibility:
Create and document qualification and validation protocols, master plans, and reports
Support validation lifecycle activities, including risk assessments, test plan creation, execution, and summary reporting
Review and approve validation protocols and reports for accuracy and completeness
Develop and maintain SOPs related to qualification and validation activities
Assist in audit preparation and participate in internal audits as needed
Collaborate with engineering, manufacturing, and R&D teams to ensure proper equipment qualification
Provide QA oversight for validation activities conducted by third-party vendors or contractors
Train and guide team members on validation processes
Act as a backup for other QA team members during absences or peak workload periods
Requirements:
Degree in Life Sciences, Engineering, or a related field
Deep knowledge of validation principles, regulatory requirements, and quality systems
Knowledge of risk management tools and methodologies (e.g., FMEA)
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Excellent organizational, analytical, and communication skills
Ability to work independently and collaboratively in a team environment
Quick learner, adaptable to fast-changing environments, and willing to adhere to strict safety and regulatory protocols