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.
Responsibilities:
1. Create and document qualification and validation protocols, master plans, and reports.
2. Support validation lifecycle activities, including risk assessments, test plan creation, execution, and summary reporting.
3. Review and approve validation protocols and reports for accuracy and completeness.
4. Develop and maintain SOPs related to qualification and validation activities.
5. Assist in audit preparation and participate in internal audits as needed.
6. Collaborate with engineering, manufacturing, and R&D teams to ensure proper equipment qualification.
7. Provide QA oversight for validation activities conducted by third-party vendors or contractors.
8. Train and guide team members on validation processes.
9. Act as a backup for other QA team members during absences or peak workload periods.
Key Skills and Requirements:
10. Degree in Life Sciences, Engineering, or a related field.
11. Deep knowledge of validation principles, regulatory requirements, and quality systems.
12. Knowledge of risk management tools and methodologies (e.g., FMEA).
13. Proficiency in Microsoft Office (Word, Excel, PowerPoint).
14. Excellent organizational, analytical, and communication skills.
15. Ability to work independently and collaboratively in a team environment.
16. Quick learner, adaptable to fast-changing environments, and willing to adhere to strict safety and regulatory protocols.