The QA Specialist will report directly to the Director Quality Assurance (QA) and will, play a key role in ensuring that clinical research activities are conducted in compliance with Good Clinical Practice (GCP), regulatory requirements (e.g., FDA, EMA), and internal quality standards. This position demands excellent attention to detail, exceptional communication skills, strong organizational abilities and critical thinking.
Reports To: Director Quality Assurance
Function: Quality Assurance
Level: Specialist/Senior Specialist
Location: Lausanne, Switzerland
The role works closely with the Director QA and other members of the quality team, as well as cross-functional development teams, to successfully implement and support Oculis’ development programs.
The ideal candidate has a bachelor’s degree (or higher) in life sciences, pharmacy or a related field and a strong understanding in data integrity principles and risk based quality management.
Key Responsibilities
* Review clinical trial documentation (e.g., protocols, investigator brochures, clinical study reports) for compliance and accuracy.
* Identify quality issues, deviations, and trends, and ensure appropriate corrective and preventive actions (CAPAs) are implemented.
* Coordinate the preparation and execution of audits, along with the follow-up actions.
* Prepare for and support sponsor, regulatory authority, and partner audits/inspections.
* Contribute to the development, implementation, and maintenance of the Quality Management System (QMS) including documentation and training management
* Monitor quality metrics, analyze trends, and recommend process improvements.
Necessary Skill Set
* Experience:
Minimum 5+ years of experience in QA within clinical research or pharmaceutical/biotech industries. Experience with electronic quality systems and electronic Trial Master Files (eTMF) and Electronic Data Capture (EDC) systems is an advantage.
* Skills:
Attention to detail and critical thinking skills, ensuring a thorough and analytical approach to quality assurance activities. organizational, time management, and project management abilities, enabling to effectively prioritize tasks. a proactive problem-solving mindset and the adaptability required to thrive in a fast-paced, dynamic environment.
* Education:
Bachelor’s degree (or higher) in life sciences, pharmacy or a related field.
Oculis is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other characteristic protected by applicable laws. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and supported. All qualified applicants will receive consideration for employment without regard to any of the aforementioned factors. We encourage individuals from all backgrounds to apply.
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