Quality Assurance Specialist - Product Development
We are seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a crucial role in ensuring the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development.
Main Responsibilities:
* GMP Oversight: Ensure the GMP oversight of different laboratories and production pilots, including packaging, and outsourcing.
* GSP Oversight: Ensure the GSP oversight (non-GMP activities) of different development entities located on various sites.
You will also be responsible for driving continuous quality improvement processes, ensuring that the Quality Management System in support of product development and clinical supplies operates efficiently, effectively, and meets regulatory requirements and expectations.
Key Accountabilities:
* Quality Improvement: Drive continuous quality improvement processes to ensure the Quality Management System supports product development and clinical supplies.
* Process Development: Develop and maintain adequate Quality systems and processes in place for the documentation of company development activities and ensure compliance with regulatory and corporate requirements.
* Regulatory Compliance: Ensure data integrity and compliance with regulatory requirements and industry best practices.
Your Profile:
* Education: Master's or bachelor's degree in a relevant field such as Life Sciences, Engineering, or Quality Management.
* Experience: Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry.
* Languages: Fluency in French and English.
* Skills: Good understanding of current regulatory requirements and expectations, ability to interpret regulations, and strong communication skills.
Our Offer:
We offer a permanent contract as consultant with an attractive salary package and access to training in technical matters and soft skills. We value your career growth and look forward to supporting you throughout your journey.