Quality Assurance Expert for Biotech Operations
Vor 2 Tagen
As a Bio DS Local Quality Specialist, you will play a crucial role in ensuring the quality and integrity of our products. You will work closely with cross-functional teams to develop and implement quality systems, oversee product documentation, and lead the site Change Control Committee.
Key Responsibilities:
* Develop and implement quality systems to ensure compliance with regulatory requirements and internal policies.
* Oversee product documentation to ensure full product knowledge and implement improvements in response to business needs, operational excellence, quality, or regulatory requirements.
* Lead the site Change Control Committee, ensuring smooth and coherent management of changes and regulatory impacts.
Requirements:
* Bachelor's degree in Quality Management, Pharmaceutical Sciences, Biotechnologies, or related field.
* At least 4 years of experience in quality assurance, with a focus on project management related to the qualification and validation of manufacturing processes.
* Strong understanding of GMP environment and demonstrated ability to write technical documents.
* Proven ability to independently manage multiple tasks and coordinate complex projects while meeting critical deadlines.
* Excellent communication skills (oral and written) in both French and English, with strong meeting preparation, presentation, and negotiation skills.
Why Join Us?
* We offer competitive compensation and benefits packages.
* Opportunities for career growth and professional development.
* A dynamic and supportive work environment.
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